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
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. 

  • On track to initiate the OPTION 2 trial by the end of Q2 2020
  • OPTION 2 trial to compare efficacy of standard of care to 2.2 and 4.4 gram doses of MS1819 in enteric capsules
  • Trial completion and top-line data expected in Q1 2021

NEW YORK, April 29, 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 the Company received approval to conduct of its Phase 2 OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI) in Therapeutics Development Network (TDN) clinical sites. The TDN is a collaborative network of CF clinical trial specialists supported by the Cystic Fibrosis Foundation (CFF). TDN support (formally called ‘sanction’ by the TDN) allows for access to 91 accredited U.S. care centers with established expertise in CF clinical research that facilitate recruitment and implementation of studies. 

The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819 using 2.2 and 4.4 gram doses in enteric capsules head-to-head against the current standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills. The study is expected to enroll 30 CF patients with target enrollment expected in Q4 2020 and study completion anticipated in Q1 2021.

“We are very pleased to receive the continued support of the Therapeutics Development Network for our Phase 2b OPTION 2 trial, which will allow for full study participation in the TDN sites,” said James Pennington, M.D., Chief Medical Officer of AzurRx. “We are optimistic that either the 2.2g or 4.4g dose of MS1819, in conjunction with the use of enteric capsules for delayed-release drug delivery, will enable us to successfully achieve our primary and secondary efficacy endpoints. A study conducted through the TDN provides a valuable platform for conduct of OPTION 2 in the U.S. and we look forward to beginning our enrollment.”

James Sapirstein, Chief Executive Officer of AzurRx, commented that “TDN approval is an important milestone for the Company and we look forward to initiating our OPTION 2 clinical trial in the CF patient population. Patients have expressed a desire for non-porcine derived alternatives to the current PERT therapies given ongoing safety and dietary concerns and now more recent concerns around availability given supply chain issues in China due to the COVID-19 pandemic and prior swine flus. We believe that our yeast-based recombinant enzyme therapy has the potential to become an effective and safer therapy for CF patients, with a more consistent and reliable manufacturing process and supply chain.”

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 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.

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, April 21, 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 hope that all is well with you and your families during these difficult and unprecedented times of the COVID-19 pandemic.  When I last wrote to you six months ago (on October 22, 2019), as the newly appointed President and CEO of AzurRx, I spoke about my strong belief in the potential of MS1819, our focus on building shareholder value and in raising sufficient capital to achieve our milestones.  I am pleased to say we have made progress towards all of these goals.  Let me now provide a more detailed update on our progress and share with you our goals for 2020 and 2021, including our plans to develop MS1819 into a Phase 3 ready asset that can potentially be monetized.

Clinical Trials

OPTION 2 Trial

Despite COVID-19, we currently anticipate only minor delays in initiating and completing our dose-escalating Phase 2 OPTION 2 monotherapy clinical trial, using 2.2g and 4.4g doses of MS1819 in enteric capsules in the U.S. and Poland.  During Q1 2020, we executed contracts with our clinical research organizations (CROs) and began preparation for the trial, including identifying the trial sites and investigators.  In addition, the clinical trial protocol has been reviewed by the FDA with no comments, and we intend to begin Institutional Review Board (IRB) reviews shortly.  Barring any significant coronavirus developments, we should be able to initiate the OPTION 2 Trial by the end of Q2 2020 and expect top line data in Q1 2021.

Combination Trial

In Q4 2019 we dosed the first patient in our Phase 2 combination therapy clinical trial in Hungary. In January 2020 we reported that the data from the first five patients in the study, for primary and secondary efficacy endpoints, was positive and that there were no safety issues.  We are completing the trial in sites in Hungary and plan to open new trial sites in Spain, and possibly in Turkey, in Q3 2020. We plan to release interim data during Q3 2020, anticipate completion of the Combination Trial by the end of 2020 and top line data in Q1 2021.

Although we are very pleased with our current clinical trial progress, the impact of COVID-19 on clinical trials changes on a daily basis and could in the future impact the progress of our trials.  We intend to provide updates if required as the COVID-19 pandemic continues to develop. 

Clinical Supply Chain (CMC)

Earlier this month we signed a manufacturing agreement with Delpharm, a leading contract development manufacturing organization (CDMO), for the clinical drug supply of MS1819 for the OPTION 2 clinical trial scheduled to initiate in Q2 2020. This marks the first time that MS1819 will be manufactured with enteric capsules, which we believe should prevent the MS1819 lipase from breaking down prior to reaching the duodenum so that substantially more (~50%) drug product can be released.  Our supply chain remains intact and, as of today, has not been impacted by COVID-19.

Relatedly, COVID-19 highlights both the health risk of animal pathogens in medicinal products and the risk of supply chain disruption, when animals are either quarantined or culled. For example, in 2019 the Chinese government ordered the culling of half of their pig population following a swine flu epidemic.  Chinese pigs are the source of a majority of the world’s porcine pancreases used in pancreatic enzyme replacement therapy (PERT) products.  In contrast, MS1819 is a synthetic recombinant yeast that can be safely and reliably produced in fermenters under the strictest quality control.

Personnel

We have taken several steps to strengthen our team, broaden our talent pool and consolidate and streamline our operations:

  • Finance: hiring Daniel Schneiderman as our Chief Financial Officer and a new Controller;
  • Clinical Operations: consolidation of all U.S.-European clinical trial programs under Jim Pennington, M.D., our Chief Medical Officer;
  • Chemistry, Manufacturing & Controls (CMC): hiring Ted Stover to serve as global Product Development Manager for MS1819; and
  • Board of Directors: appointing Greg Oakes, a seasoned biotech executive with significant experience and a track record in pharma commercialization and partnering.

Finance

We have made considerable progress in strengthening our balance sheet, realigning and reducing operating expenses and improving our financial controls.

Capital Raised

In November 2019, we entered into a purchase agreement for a $15 million equity line of credit with Lincoln Park Capital Fund, a Chicago-based institutional investor and a long-standing investor in AzurRx.  This has provided us with access to sufficient capital to move forward with our two Phase 2 clinical trials for MS1819.

As a follow up to the Lincoln Park equity line, in December 2019 and January 2020, we closed a $6.9 million private placement consisting of senior convertible promissory notes and warrants. The convertible notes are convertible into common stock at $0.97 per share, accrue interest at 9% per annum and mature on September 20, 2020. Many of our long-standing investors participated in this round, and we greatly appreciate their continued support of AzurRx.

With these funds, we have been able to continue investing in our clinical trials – by funding both the combination therapy study in Europe and preparations for the upcoming OPTION 2 monotherapy study in the United States and Poland.  Simultaneous to our fundraising efforts, we also significantly reduced our liabilities – by restructuring and paying off most of our short-term obligations, including accounts payable and promissory notes.

In addition, in Q1 2020, we received an aggregate total of $1.77 million in non-dilutive funding from our French R&D tax credit (CIR) for the years 2017 and 2018. We anticipate receiving our 2019 CIR towards the end of the year.

Finally, in April 2020, we received a CARES Act Paycheck Protection Program (PPP) loan of approximately $180,000 through the Small Business Administration (SBA). This loan, which may be forgivable, will be used to pay employees and other eligible expenses such as rent during the COVID-19 crisis.

Financial Controls and Spend

Upon joining AzurRx, one of my first objectives was to hire a new financial team to both improve our financial controls and bring them fully in-house.  As mentioned above, in Q1 2020 we hired a new CFO and Controller and they have rationalized our budgeting process, introduced cost saving measures, and introduced the appropriate controls across our U.S. and French operations. 

As part of our strategic review, we made the decision to discontinue both our AZX1103 beta-lactamase and MTAN pre-clinical programs in order to fully concentrate our resources on the development of MS1819.

As a result of these efforts, we have been able to reduce our monthly expenses, while continuing to advance our clinical programs for MS1819.  Our workforce has successfully transferred to a work-at-home setting, and I would also like to emphasize that our progress and clinical trial preparations are continuing even in the current COVID-19 environment.

Looking Ahead

I would like to reiterate my firm and continued belief in the potential for MS1819 as we remain focused on building shareholder value and executing upon our corporate objectives and milestones.  We believe that the successful completion and release of key efficacy data from the Phase 2 monotherapy and combination therapy trials in Q1 2021 represent inflection points that can increase the value of AzurRx and provides the fundamental basis for developing MS1819 into a Phase 3 ready asset.

In addition to executing on our clinical studies and releasing data, we plan to spend 2020 and early 2021 focusing on the necessary CMC and regulatory objectives needed to fully develop MS1819 for Phase 3 and commercialization.  To that end, we are planning for a new manufacturing campaign to optimize our long-term drug supply chain and evaluate process improvements to further reduce manufacturing costs.  Additionally, this campaign will support the toxicity studies needed to provide the clinical drug supply necessary to initiate our Phase 3 trial. Finally, we will be drafting a pediatric study plan to support a successful end of Phase 2 meeting with the FDA.

I believe achieving these clinical, CMC and regulatory milestones are critical in order to maximize the value of AzurRx and reward the patience and support of our investors and stakeholders.

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.

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 and the results of its clinical trials, 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, April 20, 2020 (GLOBE NEWSWIRE) -- Argus Research, an independent investment research firm, has launched Equity Research Report coverage on AzurRx BioPharma, Inc.  (NasdaqCM: AZRX)

Click here to view Full Argus Report.

Highlights, as conveyed by Argus Analyst Steve Silver, include:

COMPANY HIGHLIGHTS

 AZRX: Supporting Patients with Pancreas-Mediated Digestion Disorders

  • In our view, AzurRx’s lead product candidate, MS1819, provides a potential alternative to the current standard-of-care treatment for patients with gastrointestinal disorders orig­inating in the pancreas. The current standard of care is a porcine-based pancreatic enzyme replacement therapy (PERT), which exposes patients to the risk of infection, allergies, and potential adverse events when used at high doses; it and carries a high pill burden that can lead to patient noncompliance.
  • In December 2019 and January 2020, AzurRx raised $6.9 million in a private placement. In addition, the company received $1.8 million in R&D tax credits from the French gov­ernment for past research in March 2020. It also has access to up to $15 million in funding through an equity purchase program with Lincoln Park Capital. As such, we believe that AzurRx will have sufficient cash to advance MS1819 to value-inflection points in late 2020/early 2021.
  • We think that AzurRx’s recent valuation does not reflect the commercial prospects for the MS1819 asset given the product’s clear path to market. Our net present value analysis yields a fair value estimate for AZRX of $2.50 per share.

INVESTMENT THESIS (click here to view full Argus Equity Research Report & Investment Thesis)

About AzurRx BioPharma, Inc.  (NasdaqCM: AZRXwww.azurrx.com

AzurRx BioPharma Inc, founded in 2014, is a development-stage bio­pharmaceutical company focused on the development of recombinant proteins for the treatment of gastrointestinal diseases. The company’s lead asset is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis pa­tients). The company is headquartered in New York City, with scientific operations in Langlade, France and clinical operations in Hayward, California.

AZRX Contacts:

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. 

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NEW YORK, April 16, 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 a manufacturing agreement with Delpharm (“Delpharm”), a leading contract development manufacturing organization (CDMO), for the clinical drug product supply of its MS1819 therapy for exocrine pancreatic insufficiency (EPI). 

Under the terms of the agreement, Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis (CF).  As preparation for the cGMP batch, the drug product manufacturing process was transferred to Delpharm and they have successfully produced a non-GMP batch.  This marks the first time in which MS1819 has been manufactured with enteric capsules, which will be used in the OPTION 2 Trial to deliver MS1819 drug product during the duodenal phase of digestion.

“We are very pleased to have Delpharm continue to be our MS1819 manufacturing partner as we prepare for the launch of our OPTION 2 Clinical Trial,” said James Sapirstein, CEO of AzurRx BioPharma. “We greatly appreciate Delpharm’s commitment to continue working through the COVID-19 pandemic to produce our clinical study drug product, which will enable us to meet our planned timelines and initiate the study in Q2 2020, as expected.”

“Delpharm is very proud to play a role in supporting AzurRx’s clinical trial and helping cystic fibrosis patients gain access to this promising new treatment,” added Sébastien Aguettant, CEO of Delpharm.

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.

About Delpharm
Delpharm is a European leader in contract manufacturing and development of medicines for pharmaceutical companies, generating €750m turnover and is wholly owned by its management. Delpharm operates 17 manufacturing plants across Europe and Canada providing the majority of dosage forms available on the market, clinical batches manufacturing for Phases 1-3, and full development services.   Additional information on Delpharm can be found at www.delpharm.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 and the results of its clinical trials, 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. 

BROOKLYN, NY / ACCESSWIRE / April 15, 2020 / AzurRx BioPharma, Inc. (NASDAQ:AZRX), is a clinical stage biopharmaceutical company focused on the development of recombinant proteins for the treatment of gastrointestinal diseases, today announced that it will be presenting at the Planet MicroCap Showcase 2020 on Wednesday, April 22 at 2 PM EST. James Sapirstein, CEO and President of AzurRx BioPharma, will be hosting the presentation and answering questions from investors.

To access the live presentation, please use the following information:

Planet MicroCap Showcase Virtual Investor Conference 2020
Date: Wednesday, April 22, 2020
Time: 2:00 PM Eastern Time / (11:00 AM Pacific Time)
Webcast: https://www.webcaster4.com/Webcast/Page/2059/34159

AzurRx's lead therapeutic is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis patients). The company is currently conducting a Phase 2 combination therapy study in cystic fibrosis and plans to initiate a Phase 2b monotherapy study in cystic fibrosis in Q2 2020.

If you would like to book 1on1 investor meetings with AzurRx BioPharma, Inc. please make sure you are registered for the virtual event here: https://www.planetmicrocapshowcase.com/signup

1on1 meetings will be scheduled and conducted via private, secure video conference through the conference event platform.

If you can't make the live presentation, all company presentations "webcasts" will be available directly on the conference event platform on this link under the tab "Schedule": https://www.planetmicrocapshowcase.com/presenting-companies

News Compliments of ACCESSWIRE

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's lead drug candidate, MS1819, is 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 Planet MicroCap Showcase

Planet MicroCap Showcase brings together promising companies with well-known and influential microcap, investors, fund managers and newsletter writers for three days of company presentations, one-on-one meetings, and networking.

If you would like to attend the Planet MicroCap Showcase, please register here: https://planetmicrocapshowcase.com/signup

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.

Seasoned veteran with decades of strategic and global leadership experience

NEW YORK, April 09, 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 appointment of Gregory Oakes to the Board of Directors effective April 13, 2020.

“Greg is a strong and welcomed addition to our board,” said James Sapirstein, CEO of AzurRx BioPharma. “His broad experience in pharmaceutical commercialization and acquisitions will help AzurRx as we advance MS1819 through two Phase 2 clinical studies in 2020 and intensify our partnering discussions.”

"I am excited to join the AzurRx Board with its compelling potential synthetic alternative to PERT therapy,” said Mr. Oakes. “I look forward to helping the Company realize the full commercial potential of the MS1819 program."

Mr. Oakes brings to the AzurRx Board over 25 years of pharmaceutical industry and leadership experience.  He currently serves as Corporate Vice President – Global integration Lead for Otezla at Amgen where he is overseeing the integration and continued success of the $2B brand and positioning it for sustained growth.  Prior to Amgen, Mr. Oakes was Corporate Vice President and US General Manager at Celgene.  Mr. Oakes also served as the Global Commercial Integration Lead at Celgene where he helped steer the $74B acquisition by Bristol-Myers Squibb and the $13.4B divestiture of Otezla.  Prior to Celgene, Mr. Oakes held several positions at Novartis, most recently as Head of Sandoz Biopharmaceuticals, North America.  He began his career at Schering-Plough (Merck) where he held executive roles both in the US and Europe.  He holds a bachelor’s degree in Marketing and Business Administration from Edinboro University and a M.B.A. from Clemson University.  He currently sits on the Board of BioNJ and served on various Executive Committees at Celgene, Novartis, and Schering-Plough (Merck).

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’s lead drug candidate, MS1819, is 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. 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 and the results of its clinical trials, 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 ~$1.8 million in aggregate CIR payments in 2020
  • CIR offers support for on-going MS1819 Phase 2 clinical studies in Europe

NEW YORK, April 01, 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 it has received approximately 581,000 Euros for its 2017 CIR (French Research Tax Credit) following the successful conclusion of its audit. This marks the second CIR payment AzurRx has received in 2020. In March 2020, the Company announced it had received $1.13 million for its 2018 CIR for an aggregate total of $1.77 million in non-dilutive funding received in 2020.  In addition, the Company anticipates it will receive the 2019 CIR payment by the end of 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.

The CIR has been used to fund AzurRx’s ongoing MS1819 clinical trials, 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’s lead drug candidate, MS1819, is 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. 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 and the results of its clinical trials, 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, NY / ACCESSWIRE / March 18, 2020 / AzurRx BioPharma (NASDAQ:AZRX) will be presenting at this year's Spring Investor Summit on March 25th-26th.

During the current climate of concern, The Spring Investor Summit will now take place virtually, featuring over 500 registered executives and investors.

Investors will still be able to view all the company presentations directly in the conference event platform on the event days. 1:1's will now be scheduled and conducted via phone lines with a dedicated PIN for each meeting.

You can view our company presentation via webcast here: https://www.webcaster4.com/Webcast/Page/2038/33633 on March 25th, 2020 at 12:35 p.m. EST.

About AzurRx BioPharma

AzurRx BioPharma is a development stage biopharmaceutical company focused on the development of recombinant proteins for the treatment of gastrointestinal diseases and microbiome related conditions. AzurRx's lead therapeutic is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis patients). The company is currently conducting a Phase 2 combination therapy study in cystic fibrosis and will initiate a Phase 2b cystic fibrosis monotherapy study in 2020.

The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors.

To register as a presenting company: please contact Cassandra Miller (This email address is being protected from spambots. You need JavaScript enabled to view it.)

To request complimentary investor registration: please visit our website at www.microcapconf.com

News Compliments of ACCESSWIRE

FOR MORE INFORMATION

Please visit: www.microcapconf.com

Or, contact Cassandra Miller at This email address is being protected from spambots. You need JavaScript enabled to view it.

  • CIR provides up to 30% in non-dilutive R&D tax relief to eligible research-based French companies
  • CIR offers significant source of support for on-going MS1819 Phase 2 clinical studies in Europe

NEW YORK, March 02, 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 it has received over 1 million Euros in 2018 CIR (French Research Tax Credit) following the successful conclusion of an audit. 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.

“The 30% tax relief on R&D activities provides a significant non-dilutive funding source for our on-going research and clinical trial activities in France and Europe through our AzurRx SAS subsidiary,” said James Sapirstein, the CEO of AzurRx. “The CIR allows the Company additional flexibility to hire top-tier research scientists in France and to fund our ongoing clinical trials such as our Phase 2 MS1819 studies in Chronic Pancreatitis and Cystic Fibrosis, and our AZX1103 pre-clinical development program. We are greatly appreciative of the French government’s continued support of AzurRx SAS.”

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 MS1819
MS1819, supplied as an oral non-systemic biologic capsule, is a recombinant lipase enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.

About Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency 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 CF according to the Cystic Fibrosis Foundation. The current therapeutic standard of care for these patients are porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. 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 and final results of the Phase 2 OPTION study, are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 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. 

  • Presentation to focus on Phase II Trial of MS1819 in Cystic Fibrosis (CF)
  • Discussion of safety and efficacy endpoints of bridging dose safety study

NEW YORK, Feb. 18, 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 an oral presentation at the 2020 Digestive Disease Week (DDW) Conference being held in Chicago from May 2-5, 2020.

The presentation, entitled: “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,” will be delivered by Dr. Michael Konstan, Vice Dean for Translational Research and Professor of Pediatrics at Case Western Reserve University in Cleveland, Ohio.

Dr. Konstan will discuss the data from the Company’s Phase II study of MS1819 in patients with cystic fibrosis, which demonstrated safety, a coefficient of fat absorption (CFA) which was similar to the value at the same dose in a prior study in chronic pancreatitis, and positive unexpected findings on the coefficient of nitrogen absorption (CNA).

Presentation details:

Presentation
Title:

A PHASE 2, OPEN-LABEL, MULTICENTER, 2X2 CROSSOVER TRIAL TO ASSESS THE SAFETY AND EFFICACY OF MS1819 IN PATIENTS WITH
EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS

Presenter:

Dr. Michael Konstan, Vice Dean for Translational Research and Professor of Pediatrics at Case Western Reserve University in Cleveland, Ohio.
Session Type:Clinical Symposium
Session Title:Ion Channels, Transporters and Diarrheal Disease
Session
Date/Time:
May 5, 2020 from 2:00 PM to 3:30 PM
Presentation
Time
2:22 PM to 2:33 PM CDT
Location:McCormick Place, Chicago, IL

Phase 2 OPTION Study Design
The Phase 2 OPTION trial (NCT03746483) was an open-label, crossover study, conducted in 14 sites in the U.S. and Europe. Patients were first randomized to either the MS1819 arm, where they received a 2 gram daily oral dose of MS1819 for three weeks; or to the porcine enzyme replacement therapy (PERT) arm, where they received their pre-study dose of PERT for three weeks. After three weeks, stools were collected for analysis, and patients were then crossed over to another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were collected again for analysis. Patients were then followed for an additional two weeks for post study safety observation. A total of 32 patients, ages 18 years or older, completed the study. Topline data compared the CFA of the MS1819 treatment phase, 56%, to the CFA of the PERT treatment phase, 86%. In addition, CNAs were 93% in the MS1819 group, compared to 97% in the PERT group. Of note, MS1819 contains no protease. Safety in the OPTION trial was excellent, with no severe adverse events (SAEs) and few overall adverse events.
 
About MS1819
MS1819, supplied as an oral non-systemic biologic capsule, is a recombinant lipase enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.

About Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency 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 CF according to the Cystic Fibrosis Foundation. The current therapeutic standard of care for these patients are porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. 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 and final results of the Phase 2 OPTION study, are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 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, Jan. 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 the closing of a private placement financing (the “Offering”) resulting in gross proceeds of approximately $6.9 million from certain accredited investors. Alexander Capital, LP acted as sole placement agent in the Offering. Net proceeds from the Offering will be used to eliminate short- and long-term indebtedness, and for general working capital purposes, including product development.

James Sapirstein, the President and CEO of AzurRx, said “We are very grateful for the continued support of our investors. This financing allows us to achieve our short-term goals and continue the development of our MS1819 program for the treatment of exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients.”

The Offering consisted of Senior Convertible Promissory Notes (the “Notes”) and warrants (the “Warrants”) to purchase shares of the Company’s common stock (the “Common Stock”). The Notes mature on September 30, 2020, accrue interest at a rate of 9% per annum, and are convertible into Common Stock at $0.97 per share (the “Conversion Shares”). Warrants were issued to the investors in an amount equal to 50% of the number of Conversion Shares. The Warrants have an exercise price of $1.07 per share and expire three years from the date of issuance.

In aggregate, the Company issued $6,904,000 principal amount of Notes convertible into 7,117,559 Conversion Shares and Warrants to purchase up to 3,558,795 shares of Common Stock to the investors in the Offering.

For more detailed information on the Offering, please see the Company’s Current Report of Form 8-K to be filed with the Securities and Exchange Commission (SEC) on or about the date hereof.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. AzurRx has agreed to file one or more registration statements with the SEC registering the resale of the Conversion Shares issuable upon conversion of the Notes and the shares of Common Stock issuable upon exercise of the Warrants purchased in the Offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819-SD recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, the potential commercialization of any product we may successfully develop as well as other risk factors included in the Company's most recent quarterly report on Form 10-Q and other filings with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

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.
www.lifesciadvisors.com

 

  • Initial data from the first five patients indicate positive trends for all primary and secondary safety and efficacy endpoints in AzurRx’s Phase 2 Clinical Study for MS1819-SD, in combination with standard PERT for Cystic Fibrosis patients with severe exocrine pancreatic insufficiency.
  • New data underscore the potential of MS1819 to provide meaningful clinical benefits to patients suffering from severe exocrine pancreatic insufficiency (EPI) as an add-on therapy.

NEW YORK, Jan. 09, 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 it will present new data from five patients enrolled in its Phase 2 study for its lead development candidate MS1819-SD at the 2020 Biotech Showcase Conference being held at the Hilton San Francisco Union Square Hotel (Yosemite C - Ballroom Level) on Monday, January 13th at 3:00 p.m. Pacific Time. 

The Phase 2 clinical trial is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase the coefficient of fat absorption (CFA) and relieve abdominal symptoms in Cystic Fibrosis (CF) patients suffering from severe exocrine pancreatic insufficiency (EPI).  Patients enrolled in the study continue to experience clinical symptoms of fat malabsorption, despite efforts to control their symptoms with commercially-available PERTs.  

Data from the initial five patients showed positive trends regarding the primary efficacy endpoint of CFA improvement with no adverse events reported. Trends were also positive in the secondary endpoints of improvements in body weight and stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea. Additionally, multiple patients reported experiencing less abdominal pain while being on the combination therapy.

Dr. James Pennington, Chief Medical Officer of AzurRx, will provide an overview of the new data and the Company’s clinical development programs during a live presentation scheduled for 3:00 p.m. at the Biotech Showcase Conference. After the presentation, Dr. Pennington and James Sapirstein, the Company’s Chief Executive Officer, will be available for one-on-one meetings with investors registered for the conference.

About the MS1819-SD 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).

The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase the patient’s CFA levels and relieve abdominal symptoms. A combination therapy of PERT and MS1819-SD 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 2020.

About MS1819-SD
MS1819-SD, supplied as an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.

About Exocrine Pancreatic Insufficiency:
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency 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 engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819-SD recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop.  We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

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 
www.lifesciadvisors.com 
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