• Globally recognized experts in cystic fibrosis and chronic pancreatitis care and research to support AzurRx in advancing the clinical development of MS1819

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced the formation of a Scientific Advisory Board (SAB) including three of the leading global experts in exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

“We are thrilled to have this distinguished group of scientific leaders helping to guide our research and clinical development efforts as we advance our MS1819 program for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis patients,” said James Sapirstein, Chief Executive Officer of AzurRx.

Dr. James Pennington, Chief Medical Officer of AzurRx added, “We are proud to have attracted this illustrious team of experts to our SAB. Their deep expertise and insights will be invaluable as we continue progressing our clinical program in exocrine pancreatic insufficiency (EPI) from Phase 2 to a pivotal Phase 3 clinical trial.”

The AzurRx SAB members will include:

Michael Konstan, M.D. is Vice Dean for Translational Research and the Gertrude Lee Chandler Tucker Professor of Pediatrics at Case Western Reserve University School of Medicine, and the Austin Ricci Chair in Pediatric Pulmonary Care and Research at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, OH. Dr. Konstan has spent his entire professional career in the care and research of people with cystic fibrosis (CF). He has led numerous national and international clinical trials of potentially new therapies for CF, and his seminal work has led to several therapies that are in use today, including the only therapy recommended in guidelines for treating the lung inflammation in CF using high doses of ibuprofen. Dr. Konstan was the first recipient of the Cystic Fibrosis Foundation’s Harry Shwachman Clinical Investigator Award, and later in his career he received the Richard C. Talamo Distinguished Clinical Achievement Award from the Foundation. He has published extensively in the medical literature with more than 200 peer-reviewed publications, nearly all related to cystic fibrosis. He has served on multiple advisory boards and committees for the CF Foundation, the NIH and the FDA, all related to advancing the treatment of CF. He currently serves on the CF Foundation’s Clinical Research Executive Committee. Dr. Konstan received his bachelor’s and medical degrees from Case Western Reserve University (CWRU). After completing his internship and residency in Pediatrics at The Children’s Hospital of Buffalo, he returned to CWRU and Rainbow Babies and Children’s Hospital for Fellowship training in Pediatric Pulmonology.

Darwin L. Conwell, M.D. is a physician-scientist in gastroenterology specializing in pancreas disorders and currently Professor of Medicine with tenure at The Ohio State University College of Medicine where he serves as Director of the Division of Gastroenterology, Hepatology and Nutrition at The Ohio State Wexner Medical Center. He is an NIH-funded physician-scientist with over 200 peer reviewed publications. He has achieved extramural funding from the NIH-NIDDK, NCI, NIH-CATS, Harvard Digestive Disease Center, American College of Gastroenterology, ChiRhoClin, Inc., Solvay Pharmaceuticals and the National Pancreas Foundation.  He is a member of the NIDDK/NCI U01 Chronic Pancreatitis, Diabetes and Pancreas Cancer (CPDPC) Consortium, where he serves as the PI for The Ohio State Clinical Center. He also is a member of the NIDDK U01 Type 1 Diabetes Acute Pancreatitis Consortium, where he serves as a multi-PI.  Dr. Conwell is the former holder of the Charles Austin Doan Chair in Medicine and currently is the Floyd Beman Endowed Chair in Gastroenterology. Dr. Conwell is active in numerous gastrointestinal societies and is former President of The American Pancreatic Association.  He has served on several committees and boards at the American College of Gastroenterology and American Pancreatic Association. Dr. Conwell received a Bachelor of Science in Chemistry with Honors from Ohio University, Medical Degree from the University of Cincinnati College of Medicine and a Master’s Degree in Clinical Research from the University of Michigan.  Dr. Conwell completed internship and residency at The Christ Hospital in Cincinnati, Ohio and gastroenterology fellowship at the Cleveland Clinic Foundation. Dr. Conwell served as faculty at Cleveland Clinic for 15 years and started the Pancreas Clinic.  He later served on staff at Brigham and Women’s Hospital in Boston as an Associate Professor of Medicine at Harvard Medical School.

Michael Wilschanski, M.D. is Director of Pediatric Gastroenterology at Hadassah Hebrew University Medical Center. He has led numerous national and international studies of potentially new therapies in CF. He is the Director of the Electrophysiology Laboratory in Hadassah where he performs in vivo and in vitro measurements of electrolyte transport which is used diagnostically and therapeutically in CF. He is the past Chairman of the European Cystic Fibrosis Society Diagnostic Network, and past Chairman of ESPGHAN (European Society of Pediatric Gastroenterology, Hepatology and Nutrition) Working Group on Cystic Fibrosis and Pancreatic Disease. He is recipient of numerous international research grant to investigate pancreatic disease in children including a collaborative study from the NIH and has published nearly 150 articles extensively on all aspects of pediatric gastroenterology. Dr Wilschanski graduated from the University of London (Royal Free Medical School) and completed his Pediatric residency at Shaare Zedek Hospital in Jerusalem. He completed his 3-year fellowship in pediatric gastroenterology at The Hospital for Sick Children in Toronto, Canada. Dr. Wilschanski returned to Israel and worked as a senior pediatric gastroenterologist at Shaare Zedek before being appointed Director of Pediatric Gastroenterology Unit at the Hadassah University Hospitals (Ein Kerem and Mount Scopus) in 2003.

About MS1819

MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


  • Two clinical trial sites activated in Turkey, with patient screening initiated
  • Follows activation of six clinical sites in Hungary and dosing of first eight patients
  • Topline data expected in Q2 2021

NEW YORK, Oct. 14, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has activated two trial sites in Turkey for its Phase 2 Combination Therapy clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with severe exocrine pancreatic insufficiency (EPI). A total of eight of the expected twelve sites in Europe are now active and recruiting patients.

“We are truly pleased and encouraged by the interest in our expanding global Phase 2 Combination Trial,” said Dr. James Pennington, Chief Medical Officer of AzurRx. “The recently reported interim data suggests promising results and the full data readout is expected in the second quarter of next year. Our investigators in Turkey have been extremely diligent in driving the start-up of this trial in a very efficient and effective manner, and we look forward to our continued work with them.”

About the MS1819 Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available porcine pancreatic enzyme replacement therapy (PERTs). Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs(1,2).  Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function(3,4).

A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in Q2 2021.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.

References
(1) Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228
(2) Littlewood, J. et al, 2006, Pediatric Pulmonology, 2006, 41:35-49
(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520
(4) Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143 


NEW YORK, Oct. 07, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

Dear AzurRx Shareholders,

This week marks my one-year anniversary as President and Chief Executive Officer of AzurRx. I’d like to take this opportunity to reflect on our team’s accomplishments over the past year and to provide an update on the current status of our business operations. I am pleased to report that we have been successful in achieving many of the milestones I have originally shared with you, which I will highlight in this letter. Based on the clinical results we’ve seen to date, I continue to believe that MS1819 has the potential to replace porcine-derived pancreatic enzyme replacement therapy (PERT) as the standard of care for exocrine pancreatic insufficiency (EPI), and that we will increase shareholder value as we continue to advance the drug’s development.

Financial

Capital Raised in Past 12 Months

  • $6.9M from convertible promissory notes and warrants (December 2019 - January 2020)
  • $15.2M from Series B convertible preferred stock and warrants (July 2020)
  • $2.5M in CIR (French Research Tax Credit) (Received in 2020 for years 2017-2019)

One of the most evident indicators of our evolution over the past year is reflected in our vastly improved financial position. To that end, we have raised gross cash capital of approximately $22.1 million through our convertible notes and Series B convertible preferred stock financings, plus an additional $2.5 million in cash from the receipt in 2020 of French Research Tax Credits for the years 2017-2019. In July 2020, we received net proceeds from our Series B convertible preferred stock financing of approximately $13.5 million. Additionally, in July 2020, we solidified our financial position creating an effectively debt-free balance sheet by exchanging substantially all of our outstanding convertible notes into the Series B convertible preferred stock financing.

Ensuring the company has sufficient capital to support our business operations has been a key focus. On that note, I would like to reiterate that we are in a financially secure position to complete our two Phase 2 MS1819 clinical trial programs; the OPTION 2 monotherapy trial and the Combination therapy trial, and to begin preparations in 2021 for a pivotal Phase 3 study. While we have the ability to access up to approximately $14 million in additional capital through an equity line program with Lincoln Park Capital, we do not anticipate accessing such financing and are suspending any near term draw-downs as we have enough cash on hand to fund the Company’s existing operational and clinical plans through Q3 2021.

Sizing Down Scientific Operations

As our company has successfully shifted from researching preclinical assets to developing clinical assets, we made the decision to discontinue both our AZX1103 beta-lactamase and MTAN pre-clinical programs earlier this year and to close our laboratory located in France by the end of this year. While we will maintain a small administrative office to oversee our European clinical trials, closing the laboratory and reducing headcount will further cut our expenses as we continue to prudently manage our finances.

Clinical

We have made significant progress in advancing our MS1819 clinical program during the past year.

Phase 2b Cystic Fibrosis OPTION 2 Trial

  • Trial initiated Q3 2020
  • Dose escalation trial, using enteric capsules, designed to investigate the safety, tolerability and efficacy of MS1819 in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills (30 patients)
  • Primary efficacy endpoint is the coefficient of fat absorption (CFA)
  • Eight sites in the U.S. and three sites in Europe activated
  • Enrollment is ongoing
  • Top line data expected in Q1 2021

The Phase 2b OPTION 2 monotherapy dose escalation trial, using enteric capsules in a head-to-head comparison to PERT, was initiated in July. To date, we have activated a total of 11 sites and patient enrollment and dosing are ongoing. Despite the challenges of running a clinical trial during the COVID-19 pandemic, we are encouraged by the pace of enrollment and anticipate top line data in Q1 2021.

Phase 2 Cystic Fibrosis Combination Trial

  • Trial initiated Q4 2019
  • Dose escalation study, atop a stable dose of PERT, in patients with severe EPI (20 patients)
  • Primary efficacy endpoint is the coefficient of fat absorption (CFA)
  • Positive CFA interim data on first 5 patients (25% of study)
    • Clinically meaningful data in first five patients; primary and secondary efficacy endpoints met with no safety issues
  • Enrollment is ongoing
  • Sites in Hungary activated, Spain and Turkey pending
  • Top line data expected in Q2 2021

In August, we released positive interim data on the first five patients in the Phase 2 Combination trial. As reported, the primary efficacy endpoint was met, with CFAs greater than 80% for all patients across all visits, which are clinically meaningful. For secondary efficacy endpoints, we observed that stool weight decreased, the number of stools per day decreased, steatorrhea improved, and body weight increased. Additionally, no serious adverse events were reported. We are continuing to enroll patients in Hungary and seeking to initiate sites in Spain and other European countries. Unfortunately, Spain has recently reported a surge of COVID-19 cases again and any potential lockdowns may affect our site initiation and enrollment. To mitigate this risk, we are planning to open sites in Turkey and also evaluating additional sites in Eastern Europe. We are taking all the necessary steps to minimize delays and ensure continued recruitment into the trial in order to have top line data in Q2 2021.

Management and Board Additions

One of the most important assets of any company is its personnel, and over the last twelve months we’ve made some great additions to our team, namely Daniel Schneiderman as Chief Financial Officer and Gregory Oakes, to our Board of Directors. We have also made additional new hires to strengthen our internal financial controls and to effectively manage our manufacturing program. I am very proud of our team and culture; we work collaboratively, and everyone is dedicated to the continued success of AzurRx.

Outlook Ahead

Despite obvious challenges presented by COVID-19, we have made tremendous progress this year and expect to continue moving forward. We are committed to the business and clinical developments outlined in my previous letters and are confident that 2021 will bring additional value building catalysts and events as we advance the clinical development of MS1819, undergo animal toxicity studies, and create a pediatric plan before an anticipated end of Phase 2 meeting with the FDA in 2021.

We will continue our investor and public relations initiatives and position the company to attract new investors through conferences and individual meetings. In parallel, we are continuing our partnering outreach to PERT strategics and GI specialty pharma companies and anticipate further discussions following the release of topline data from our two Phase 2 clinical trials.

We look forward to sharing our future successes and thank you for your continued support.

Sincerely,

James Sapirstein
President & CEO
AzurRx BioPharma, Inc.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in Brooklyn, NY and clinical operations in Hayward, CA.  Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements

This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it. 


Abstracts to Focus on:

Results from Phase 2, Open-Label, Multicenter, 2x2 Cross-Over Trial to Assess Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

&

Best Enteric Capsule for Targeted Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme

NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that two abstracts have been accepted for presentation at the North American Cystic Fibrosis Conference (NACFC) to be held virtually October 7 – October 23, 2020. The abstracts will be showcased in the NACFC virtual poster gallery and electronically published as a supplement to Pediatric Pulmonology.

“We are pleased to present the results from the Phase 2 OPTION clinical trial demonstrating that the non-porcine MS1819 lipase is well-tolerated with no clinically significant safety signals at the 2g daily dose,” said James Sapirstein, President & CEO of AzurRx. “Furthermore, we have evaluated four different enteric capsules and identified the best suitable formulation for MS1819 that provides gastroprotection of enzyme content and delayed release into the duodenum. Our clinical program continues to advance, and we are determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy (PERT), significantly reducing the pill burden of cystic fibrosis patients.”

Presentation Poster Details Below:

Title:Results From a Phase 2, Open-Label, Multicenter, 2X2 Cross-Over Trial to Assess the Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis”
Poster #:228
Presenter:Michael Konstan, MD – Case Western Reserve University
Time:Available virtually to registered attendees starting on October 7, 2020


Title:“Evaluation and Selection of An Enteric Capsule for Targeting Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme”
Poster #:243
Presenter:Mathieu Schué, PhD – Head of Laboratory, AzurRx BioPharma, Inc.
Time:Available virtually to registered attendees starting on October 7, 2020

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110
Phone: 617-430-7578
This email address is being protected from spambots. You need JavaScript enabled to view it.


NEW YORK, Aug. 31, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be making company presentations at two upcoming investor conferences: the 2020 H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14th at 4:30 p.m. Eastern Time and the 2020 LD 500 Virtual Conference on Friday, September 4th at 11:40 a.m. Eastern Time.

AzurRx CEO and President James Sapirstein will be presenting to a live virtual audience and will be participating in one-on-one meetings with investors who are registered to attend the two conferences.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


Update (8/27/20): AzurRx’s LD 500 Presentation has been moved to Friday, September 4th at 11:40 AM Eastern Time/8:40 AM Pacific Time.

LOS ANGELES, CA / ACCESSWIRE / August 18, 2020 / AzurRx BioPharma, Inc. (NASDAQ:AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be presenting at the LD 500 investor conference on Tuesday, September 1st at 2:20 PM Eastern Time/11:20 AM Pacific Time. AzurRx CEO and President James Sapirstein will be presenting to a live virtual audience and will be participating in one-on-one meetings with investors who are registered to attend the conference.

Register here: https://ld-micro-conference.events.issuerdirect.com/

"We have been waiting for this moment all year long. Due to COVID, it has been nearly impossible for physical conferences to even take place. I want to show the world that you can still learn, have a great time, and see some of the most unique companies in the capital markets today. All without having to step foot outside. For the first time, LD Micro is accessible to everyone, and we are honored to welcome you to one of the most trusted platforms in the space." stated Chris Lahiji, Founder of LD.

The LD 500 will take place on September 1st through the 4th.

View AzurRx's profile here: http://www.ldmicro.com/profile/AZRX

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis patients). AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy (PERT), the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

About LD Micro

Back in 2006, LD Micro began with the sole purpose of being an independent resource to the microcap world.

What started as a newsletter highlighting unique companies, has transformed into the pre-eminent event platform in the space.

The upcoming "500" in September is the Company's most ambitious project yet, and the first event that is accessible to everyone.

For those interested in attending, please contact David Scher at This email address is being protected from spambots. You need JavaScript enabled to view it. or visit www.ldmicro.com for more information.

Contact:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110
Phone: 617-430-7578
This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: AzurRx BioPharma via LD Micro

  • Three clinical trial sites activated in Poland, with patient screening initiated
  • Follows activation of six clinical sites in the U.S. and dosing of first three patients
  • Topline data expected in Q1 2021

NEW YORK, Aug. 17, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its initial European trial sites are active and screening patients for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). A total of nine of the expected fifteen sites globally are now active and recruiting patients. Top line data from the study are anticipated in Q1 2021.

“We are moving forward swiftly with our OPTION 2 clinical trial and are pleased to have activated the first three European clinical trials sites in Poland,” said Dr. James Pennington, Chief Medical Officer of AzurRx. “We now have nine clinical sites activated globally, six of which are in the U.S., and are optimistic that all fifteen clinical trial sites will be screening patients in September.  With our first three patients dosed already, we anticipate having top line data from this trial in Q1 2021 as expected.”

James Sapirstein, Chief Executive Officer of AzurRx, added, “Our team is successfully advancing both of our MS1819 clinical programs and actively initiating new clinical trial sites and screening and enrolling patients. We look forward to the successful completion of the OPTION 2 monotherapy trial and the Combination therapy trial in 2021.”

Phase 2b OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The primary efficacy endpoint is the coefficient of fat absorption (CFA).

It will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  

MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


  • First three patients enrolled in dose escalation trial using delayed-release enteric capsules
  • Topline data expected in 1H 2021

NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that is has enrolled the first three patients in its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial will enroll approximately 30 CF patients with top line data from the study anticipated in 1H 2021.

The Phase 2b multi-center study is designed to investigate the safety, tolerability, and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care.  The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA).

“Enrolling the first patient in our Phase 2b OPTION 2 trial is an important milestone and we appreciate the support from our clinical trial specialists and centers. We are optimistic that our delayed-release delivery of MS1819 will achieve our primary and secondary efficacy endpoints in this study,” said Dr. James Pennington, Chief Medical Officer of AzurRx. “We anticipate data from this trial will inform the optimal dose for our pivotal Phase 3 study, and look forward to top line results in the first quarter of next year.”

James Sapirstein, Chief Executive Officer of AzurRx, added, “We are very pleased to announce that patient dosing in the OPTION 2 trial has begun in the U.S. This represents an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis. Despite the challenges posed by the COVID-19 pandemic, the AzurRx team has been able to successfully activate new clinical trial sites and work with investigators to safely admit patients into the trial.”

Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum.  Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819.  All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:
LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


NEW YORK, Aug. 12, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

Dear AzurRx Shareholders,

I am writing to provide clarification on yesterday’s press release and conference call where we discussed the positive interim data from the first patient cohort of our combination therapy trial.  We have also received a number of questions from investors regarding the study, our clinical trial timelines, our financing needs and recent changes to our proposed 2020 equity incentive plan and I would like to take this opportunity to clarify any misunderstandings and update you on recent developments.

Clinical Trials

Combination Therapy Trial

As reported yesterday, we believe that the interim data from the first cohort of five patients in the trial (of daily dose of PERT with MS1819 in patients with cystic fibrosis with severe exocrine pancreatic insufficiency) is positive and clinically meaningful.  Our data and analysis shows that MS1819 is clearly responsible for the change in the Coefficient of Fat Absorption (CFA) and the improvements in the primary and secondary efficacy endpoints were consistent for all patients, across all visits.  By way of summary:

  • The Primary Efficacy Endpoint was met
    • CFA > 80% for all patients, across all visits
       
  • The Secondary Efficacy Endpoints all showed positive changes
    • Stool Weight decreased
    • The number of Stools/Day decreased
    • Steatorrhea improved
    • Body Weight increased

  • Safety – MS1819 is safe, with no serious adverse events

Option 2 Trial

On July 22nd, we announced the initiation of the Phase 2b OPTION 2 clinical trial of MS1819 in patients with cystic fibrosis, with the first patient screened and the first three clinical trial sites activated.  The trial is proceeding according to schedule and we will be providing updates in due course.

Clinical Trial Timelines

Prior to COVID-19 we anticipated top-line results from both Phase 2 clinical trials by the end of Q4 2020. Subsequently, we have revised this to the release of topline data for OPTION 2 in Q1 2021 and the release of topline data for the combination therapy trial in Q2 2021 (1H 2021), barring any major disruptions from a second wave of COVID-19. Based on communication with our clinical trials sites in the U.S. and Europe we do not anticipate delays to these new timelines.  As discussed on yesterday’s call, European sites are re-opening and being initiated for the Combination Therapy trial and the OPTION 2 clinical trials sites in the U.S. are being activated and patients are currently been screened for enrollment.

Financing and Capitalization

On July 16th, we completed a private placement (the “Series B Private Placement”) of Series B Preferred Stock and warrants that resulted in gross cash proceeds of approximately $15.2 million and net cash proceeds of $13.5 million, and we additionally exchanged approximately $6.9 million principal amount plus accrued interest of senior convertible promissory notes into the Series B Private Placement.

As a result of the Series B Private Placement, the Company is in a secure financial position with a debt-free balance sheet and sufficient cash on hand to fund our operations for over a one-year period (currently expected through Q3 2021) that will enable us to complete our two Phase 2 clinical trials and initiate preparations for a pivotal Phase 3 clinical trial of MS1819.

As such, I want to reiterate that we are not looking to raise any additional capital to fund the Phase 2 MS1819 clinical programs. 

Following the Series B Preferred Stock transactions, we currently have a total of approximately 87.5 million shares of common stock or reserved for issuance upon exercise or conversion of currently outstanding Series B Preferred Stock, warrants and stock options.

Equity Incentive Plan

I want to clarify a few things regarding the amended and restated 2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which has been designed with an expected life of ten years.

Firstly, we are very mindful of the potential dilution resulting from the 2020 Plan and other capital raises. We have proposed an initial 10,000,000 shares, which is approximately 11-12% of the current fully diluted outstanding.

Secondly, the 2020 Plan aims to initially authorize 10,000,000 shares with potential increases to maintain availability of up to a maximum of 10% of the fully diluted share outstanding, on an as converted basis (not including shares issued and reserved under the 2020 Plan). This is consistent with the increases that have to date been automatically made under the current 2014 Omnibus Equity Incentive Plan (the “2014 Plan”). However, the proposed 2020 Plan increases are only effected on an annual basis every January 1st, rather than on a rolling basis, as per the current 2014 Plan. The proposed 2020 Plan also gives our board of directors discretion not to have such increases take effect, whereas under the 2014 Plan such increases were automatic.  Both are key differences, which impose greater limitations on potentially dilutive increases under the 2020 Plan, as compared to what the 2014 Plan allows.

Lastly, the number of permitted to be issued as “incentive stock options” (“ISOs”) under the 2020 Plan has been reduced, in our amended and restated proxy statement just refiled earlier this morning, to 15,000,000 from 100,000,000. I want to be very clear that this number in no way means that these shares have been authorized to be issued, but rather establishes a permanent maximum limit for reasonable capital expansion over the expected ten-year life of the 2020 Plan.

Looking Ahead

We are committed to delivering on our milestones and focused on executing our plan to have topline data for the Phase 2b OPTION 2 monotherapy trial in Q1 2021 and the Phase 2 combination therapy trial in Q2 2021. We have raised sufficient capital to fully fund both trials and to begin preparations for a pivotal Phase 3 trial by the end of 2021. Our interim data from the combination therapy trial is positive and demonstrates that MS1819 has efficacy and is safe.  The OPTION 2 monotherapy trial is actively recruiting patients.

I believe that we are on track and will be successful in meeting our objectives and increasing shareholder value.

Once again, I want to extend my personal thanks to all of you for your support of AzurRx and my personal wish that you and your loved ones stay healthy and safe.

Best regards,

James Sapirstein
President & CEO
AzurRx BioPharma, Inc.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California.  Additional information on the Company can be found at www.azurrx.com.

Important Information about the 2020 Annual Meeting

The Company has filed with the Securities and Exchange Commission (the “SEC”) a definitive proxy statement in connection with the matters to be considered at the 2020 Annual Meeting of Stockholders (the “2020 Annual Meeting”), which it anticipates to mail its stockholders on or about August 11, 2020.  The definitive proxy statement contains important information about the Company and the matters to be considered at the 2020 Annual Meeting. Stockholders are urged to read the proxy statement carefully. Stockholders are able to obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the SEC’s website at www.sec.report. In addition, Stockholders are able to obtain free copies of the proxy statement from the Company by contacting the Chief Financial Officer at (646) 699-7855.

The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies with respect to the matters to be considered at the 2020 Annual Meeting. Additional information regarding interests of such participants is included in the Company’s definitive proxy statement, which was initially filed with the SEC on August 7, 2020, as amended and restated on August 11, 2020.

Forward-Looking Statements

This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:
LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it. 

 


  • Data from first five patients demonstrate positive results with primary efficacy and secondary safety endpoints achieved
  • Clinically meaningful improvement (>80%) in coefficient of fat absorption (CFA) for all patients across all dose levels of MS1819
  • Topline data from full dataset anticipated in 1Q 2021

Management to discuss the interim results on call scheduled for today, August 11, 2020, at 4:30 p.m. Eastern Time

NEW YORK, Aug. 11, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced positive results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (CFA) at each of the three dose levels, with no adverse safety events reported. Additionally, patients showed improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea.

Results from the initial five patients in the trial show an improvement in CFA above 80% (the FDA’s measure for adequate nutrition) across all dose levels and on all visits. Mean CFA at the 700mg/day, 1200 mg/day and 2240 mg/day doses of MS1819 plus standard of care were 88.4%, 87.2% and 86.5% respectively, compared to baseline level (78.4%). This represents an average increase of 9 points in CFA during the trial.

“We are thrilled to see such consistently positive responses from these initial patients in our ongoing Phase 2 combination therapy trial with MS1819. EPI is a very challenging disease with many CF patients unable to achieve healthy nutrition even when using the maximum number of allowed or tolerated PERT capsules, especially those in the moderate-severe categories,” said James Sapirstein, Chief Executive Officer of AzurRx. “We look forward to completing treatment of all patients and announcing top line data in 2021.”

Dr. James Pennington, Chief Medical Officer of AzurRx added, “To see these results in the first five patients is quite compelling. With its safety and efficacy profile, MS1819 has the potential to meaningfully improve the quality of life for many patients with severe EPI. The pill burden of PERT therapy alone is quite challenging for most patients, and for severe EPI patients the symptoms of the disease can be debilitating. We believe that a small daily dose of MS1819, when added to their daily dose of PERT, has the potential to safely help CF patients meet their nutritional needs, decrease abdominal pain and alleviate multiple morbidities caused by severe EPI. We are excited to continue developing this exciting therapy and are committed to bringing this therapy to market.”

The Phase 2 clinical trial of MS1819 in combination with PERT therapy in the treatment of CF patients with severe exocrine pancreatic insufficiency is a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819, in conjunction with a stable dose of PERTs in order to increase the patient’s CFA levels and relieve abdominal symptoms. The study is expected to enroll 24 patients, 12 years of age or older, with severe EPI, with the goal of having at least 20 patients completing. Patients enrolled in the study receive escalating doses of 700mg, 1200mg, and 2240mg of MS1819 once a day for 15 days per dosing level, in addition to their standard PERT therapy. Baseline CFA is established by measuring CFA levels while on standard of care therapy only, before beginning combination therapy. Eligibility requires a CFA of less than 80%. The primary efficacy endpoint of the trial is improvement in CFA; secondary endpoints of the study are improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.

Additional information about the ongoing Combination Therapy study can be found at: https://clinicaltrials.gov/ct2/show/NCT04302662

Conference Call and Webcast Information
The management team will host a conference call to discuss results from the five patients in the Phase 2 study of MS1819 in combination with PERT therapy, today, Tuesday, August 11, 2020 at 4:30 pm Eastern Time.  To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13707811.  The live conference call can be accessed via audio webcast at http://public.viavid.com/index.php?id=141064. A replay of the call will be available on the “Investor Relations section of the Company’s website (www.azurrx.com).

About the MS1819 Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs(1,2).  Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function(3,4).

A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in 1Q 2021.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.
There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.

References
(1) Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228
(2) Littlewood, J. et al, 2006, Pediatric Pulmonology, 2006, 41:35-49
(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520
(4) Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143 


  • Three OPTION 2 clinical trial sites activated in the U.S.
  • Topline data expected in Q1 2021

NEW YORK, July 22, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has initiated its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI) with the activation of three clinical sites and initial screening of the first patient.  Top line data from the study are anticipated in Q1 2021.

The Phase 2b multi-center study is designed to investigate the safety, tolerability, and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint is the coefficient of fat absorption (CFA). Planned enrollment is expected to include approximately 30 CF patients in the U.S. and Poland.

“We are excited to be a clinical trial site in the OPTION 2 study and to continue participating in AzurRx’s ongoing efforts to find a safe non-porcine enzyme replacement therapy for our patients with cystic fibrosis,” commented Steven R. Boas, M.D., FAAP, FACCP, President and CEO, The Cystic Fibrosis Institute. “I believe that the clinical protocol provides optimal safety conditions for participating patients and care providers, given concerns about COVID-19, and I am confident that we will be able to meet our enrollment targets for the trial in a timely fashion.”

Dr. James Pennington, Chief Medical Officer of AzurRx, added, “We have designed the OPTION 2 efficacy study based on the results from the OPTION bridging dose safety study, and are optimistic that the enteric capsules delayed-release delivery of the 2.2g and 4.4g doses of MS1819 will enable us to achieve our primary and secondary efficacy endpoints in this study. We thank our clinical collaborators and participating patients for their support of OPTION 2 and look forward to our clinical results.”

“The initiation of the OPTION 2 trial is a major clinical milestone for the Company,” said James Sapirstein, Chief Executive Officer of AzurRx. “Previous clinical trials have demonstrated that MS1819 is safe and well tolerated. With this trial, we are moving ahead to determine the optimal dose for MS1819 in preparation for a pivotal Phase 3 study. We look forward to the successful completion of the trial and to reporting our topline results of OPTION 2 in Q1 2021.”

Phase 2 OPTION 2 Trial Design

The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum.  Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819.  All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819

MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


  • Private placement resulting in gross cash proceeds of $15.2 million to advance two Phase 2 clinical trials of MS1819 in patients with cystic fibrosis
  • Exchange of $6.9 million principal amount of outstanding promissory notes into private placement strengthens balance sheet

NEW YORK, July 20, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma (NASDAQ: AZRX), (“AzurRx” or the “Company”), today announced that on July 16, 2020, it entered into a Convertible Preferred Stock and Warrant Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited and institutional investors relating to the private placement (the “Private Placement”) of certain shares of convertible preferred stock and warrants for cash and in exchange for certain outstanding promissory notes as described below.

Pursuant to the Purchase Agreement, the Company issued an aggregate of 2,912.583124 shares of Series B Convertible Preferred Stock (the “Series B Preferred Stock”), at a price of $7,700.00 per share, initially convertible into an aggregate of 29,125,833 shares of the Company’s common stock (the “Common Stock”) at $0.77 per share, together with warrants (the “Series B Warrants”) to purchase an aggregate of 14,562,957 shares of Common Stock at an exercise price of $0.85 per share and a term of five years. The gross cash proceeds of the Private Placement were approximately $15.2 million, before deducting placement agent compensation and other offering expenses. 

Additionally, in connection with the Private Placement, the Company entered into an exchange addendum to the Purchase Agreement with certain investors, relating to the exchange of, as consideration in the Private Placement, of approximately $6.9 million aggregate in principal amount, plus all accrued and unpaid interest thereon, of its outstanding Senior Convertible Promissory Notes (the “Promissory Notes”), originally due in September 2020 (the “Exchange”).  As additional consideration for entering into the Exchange, the Company also issued to those investors certain additional warrants (the “Exchange Warrants”) to purchase an aggregate of 1,772,972 shares of Common Stock. The Exchange Warrants have the same terms as the Series B Warrants. The Company anticipates prepaying the outstanding balance of $25,000 aggregate principal amount of Promissory Notes, together with accrued and unpaid interest thereon through such prepayment date, held by non-participating holders in the Exchange, following which no Promissory Notes will remain outstanding.

“We are excited to have attracted the support of both new and existing investors for this financing, which funds our two Phase 2 clinical trials and Phase 3 preparations. In addition, the promissory note exchange furthers strengthens our balance sheet by removing $6.9 million in near-term debt obligations,” said James Sapirstein, Chief Executive Officer of AzurRx. “We thank the team at Alexander Capital for their continued support of the Company and their dedication to making these transactions a success.”

AzurRx currently intends to use the net cash proceeds from the Private Placement for research and development expenses associated with its continuing clinical development and testing of MS1819 and for other general corporate purposes and capital expenditures.

Alexander Capital L.P. acted as sole placement agent for the Private Placement and financial advisor for the Exchange.

Pursuant to the Private Placement and the Purchase Agreement, and for purposes of complying with Nasdaq Listing Rule 5635(c) and 5635(d), the Company is required to hold a meeting of its stockholders not later than 60 days following the closing of the Private Placement to seek approval (the “Stockholder Approval”) for, among other things, the issuance of shares of Common Stock upon full conversion of the Series B Preferred Stock and full exercise of the Series B Warrants and the Exchange Warrants, which the Company will include in the matters to be voted on at its upcoming annual meeting.

The Company simultaneously announced that its annual meeting of stockholders for 2020 (the “Annual Meeting”) will be held on September 11, 2020 at 9:00 a.m., Eastern Time at the offices of Lowenstein Sandler LLP located at One Lowenstein Drive, Roseland, New Jersey, 07068, or at such other time and location to be determined by the authorized officers of the Company and set forth in the Company's proxy statement for the Annual Meeting, and established July 31, 2020, as the record date for determining stockholders entitled to notice of, and to vote at, the 2020 Annual Meeting.

Because the date of the 2020 Annual Meeting will be more than 30 days from the anniversary of the Company’s 2019 annual meeting of stockholders, the deadline for submission of proposals by stockholders for inclusion in the Company’s proxy materials in accordance with Rule 14a-8 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), will be 5:00 p.m. Eastern Time on July 24, 2020 (the “Proposal Deadline”), which the Company has determined to be a reasonable time before it expects to begin to print and distribute its proxy materials prior to the 2020 Annual Meeting. Any such proposal must also meet the requirements set forth in the rules and regulations of the Exchange Act in order to be eligible for inclusion in the proxy materials for the 2020 Annual Meeting, and should be sent in writing to the Corporate Secretary at the following address: AzurRx BioPharma, Inc., Attention: Chief Financial Officer, 760 Parkside Avenue, Downstate Biotechnology Incubator, Suite 304, Brooklyn, NY 11226.

The securities sold in the Private Placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (SEC) registering the resale of the securities sold in the private placement no later than 10 days after the closing of the private placement and cause such registration statement to be declared effective by the SEC promptly following the Stockholder Approval, but in no event later than 30 days after the date of the Stockholder Approval (or 60 days after the date of the Stockholder Approval if the SEC conducts a full review of the registration statement). Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

For more information regarding the Private Placement and Exchange, please see our Form 8-K filed with the SEC on or about July 20, 2020.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Additional Information about the Private Placement and the Exchange  and Where to Find It
The Company will file with the SEC and mail to its stockholders a proxy statement in connection with the Private Placement and the Exchange. THE PROXY STATEMENT WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE PRIVATE PLACEMENT, THE EXCHANGE AND RELATED MATTERS. INVESTORS AND OTHER SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT CAREFULLY WHEN IT IS AVAILABLE. Investors and other security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the SEC’s website at www.sec.gov. In addition, Investors and other security holders will be able to obtain free copies of the proxy statement from the Company by contacting the Chief Financial Officer at (646) 699-7855. The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies with respect to Private Placement and the Exchange. Additional information regarding interests of such participants is included in the Company’s Annual Report on Form 10-K, as amended, for the year ended December 31, 2019, which was filed with the SEC on March 30, 2020 and amended on April 29, 2020.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: 646-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.


NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has entered into an agreement with Creapharm Clinical Supplies (“Creapharm”), a leader in clinical trial supply services, for the packaging, labelling and distribution of Phase 2 clinical trial drug product supply of its MS1819 therapy for the treatment of exocrine pancreatic insufficiency (EPI). 

Under the terms of the agreement, Creapharm will package, label, provide qualified person (QP) release and distribute AzurRx’s MS1819 clinical trial drug product for both the upcoming Phase 2b OPTION 2 Monotherapy and the ongoing Phase 2 Combination Therapy clinical trials for the treatment of EPI in patients with Cystic Fibrosis (CF). MS1819 clinical trial drug supply will be sent directly to clinical sites in the U.S. and in Europe, including, Poland, Hungary, Spain and Turkey from Creapharm’s U.S. and European depots, respectively.

James Sapirstein, CEO of AzurRx BioPharma stated, “We are very pleased to have Creapharm as our clinical trial packaging and distribution partner for both the Phase 2b OPTION 2 trial in the U.S. and Poland and the Phase 2 Combination Therapy trial in Hungary and additional countries in Europe including Spain and possibly Turkey. Despite the disruptions in global supply and distribution from the COVID-19 pandemic our clinical trial supply chain is firmly in place and we are on track to both initiate the OPTION 2 trial and to expand the Combination Therapy trial.”

“We are delighted to support AzurRx in managing drug product supply for these two clinical trials and proud that our team has successfully been able to take up the challenge of meeting AzurRx’s specifications and timelines.“ said Eric Placet, CEO of CREAPHARM GROUP.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is focused on the development of its lead drug product candidate, MS1819, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

About CREAPHARM
CREAPHARM CLINICAL SUPPLIES provides pharma and biotech companies worldwide with a variety of services including clinical primary and secondary packaging, EU QP-Release and global distribution services. CREAPHARM CLINICAL SUPPLIES, a division of the CREAPHARM GROUP, is headquartered in France with three pharmaceutical plants: Reims (France), Le Haillan (France) and Atlanta (USA). Additional information can be found at www.creapharm.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.

  • Received ~$2.52 million in aggregate CIR payments in 2020
  • CIR to be used to fund on-going MS1819 Phase 2 clinical studies in Europe

NEW YORK, May 05, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced AzurRx SAS, its wholly-owned subsidiary in France, has received approximately 661,000 Euros ($721,000 US) for its 2019 CIR (French Research Tax Credit). This marks the third CIR payment AzurRx SAS has received in 2020.  Since March including the 2019 CIR, the Company has received approximately $2.52 million in non-dilutive funding in research tax credits from the French government.

James Sapirstein, Chief Executive Officer of AzurRx commented, “We are very pleased to receive the 2019 CIR and very appreciative of the French government’s support, as we originally anticipated that we would receive the 2019 CIR towards the end of the year.  We plan to re-invest the CIR in our ongoing European Phase 2 MS1819 combination therapy trial and the Phase 2b OPTION 2 monotherapy clinical trial which will be initiating in several weeks.”

Mr. Sapirstein added, “With the addition of these CIR funds and in light of the recent guidance from the U.S. Department of Treasury and the Small Business Administration, we will be returning in full the loan which we received through the CARES Act Paycheck Protection Program in April 2020.”

The French R&D tax credit initiative (“Crédit d’Impôt Recherche”, or CIR) gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities in France and the European Union.

The CIR has previously been used to fund AzurRx’s ongoing MS1819 clinical trials in Europe, including its Phase 2 Combination therapy study in Cystic Fibrosis.

About CIR
The Research Tax Credit (CIR) is a tax incentive provided by the French Government to encourage the growth of businesses' competitiveness by favoring research and development (R&D) and innovative activities. It is particularly adapted to the needs of small and medium-sized enterprises.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders.  The Company is focused on the development of its lead drug product candidate, MS1819, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California.  Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019  under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
This email address is being protected from spambots. You need JavaScript enabled to view it.

  • IRB protocol approval provides green-light to initiate trial at U.S. clinical sites

NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has received Institutional Review Board (IRB) approval of its Phase 2 OPTION 2 clinical trial protocol to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).

“We are very pleased to receive IRB approval and look forward to entering the clinic,” said James Pennington, M.D., Chief Medical Officer of AzurRx. “We believe it is important to have a synthetic recombinant alternative to the current porcine derived PERT treatment, and optimizing our MS1819 dose is one more step forward towards realizing this goal.  We look forward to working with our clinical collaborators and participating patients to test the efficacy of a higher dose of MS1819 and enteric capsules in this study.”

James Sapirstein, Chief Executive Officer of AzurRx added, “We are moving all the critical regulatory, clinical and manufacturing pieces into place to initiate the OPTION 2 trial.  The FDA has reviewed the clinical trial protocol with no comments;  IRB protocol approval allows us to initiate the trial at U.S. clinical sites; and the recently announced support by the Therapeutics Development Network (TDN) to conduct our clinical study allows for access to its 91 accredited U.S. care centers with established expertise in CF clinical research.  We are now actively engaging clinical sites in the U.S. and Europe for the trial and, barring any coronavirus delays, look forward to initiating this trial in the coming weeks.”

Phase 2 OPTION 2 Trial Design
The Phase 2 OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head manner versus the current standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills. The OPTION 2 trial will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum.  Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption (CFA).  Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819.  All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by a deficiency of the pancreatic digestive enzymes in the intestinal tract needed to breakdown the nutrients in food so that they can be properly absorbed.  This deficiency results in abdominal discomfort and pain, frequent bowel movements, steatorrhea, poor fat absorption, weight loss and chronic malnutrition.

There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation, and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. The current therapeutic standard of care for these patients are porcine pancreatic enzyme replacement therapy (PERT) pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California.  Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019  under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Company contact:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 304
Brooklyn, NY 11226
Phone: (646)-699-7855
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Investor Relations contact:
LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
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