On track to report top line data in Phase II OPTION Study in September 2019
NEW YORK, Aug. 13, 2019 (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, reported financial results for the three and six months ended June 30, 2019 and highlighted recent corporate progress.
Recent Corporate Progress
- Announced that the first patients were dosed in an open-label, cross-over Phase II OPTION Study with MS1819-SD for exocrine pancreatic insufficiency (“EPI”) in cystic fibrosis (“CF”) in February 2019 and that the study enrollment target was met in May 2019. The Company continues to expect results from the study in September 2019.
- Initiated a Phase 2 clinical trial in July 2019 to investigate MS1819-SD in combination with standard porcine enzyme replacement therapy (“PERT”) for patients with CF who suffer from EPI but continue to experience clinical symptoms of fat malabsorption, despite taking the maximum daily dose of PERT.
- Notice of Allowance for U.S. and Japan patents covering a MTAN inhibitor for treating H. pylori infections, the primary cause of stomach ulcers, in June 2019.
- Presented Positive Secondary Endpoint Data in its Phase II MS1819-SD Chronic Pancreatitis Study at the May 2019 Digestive Disease Week Conference.
- Expanded commercialization rights to MS1819-SD as a result of the acquisition of intellectual property surrounding MS1819-SD from Laboratoires Mayoly Spindler, SAS; AzurRx now has full development control of the MS1819 program as of April 2019.
“AzurRx continues to make great strides in our clinical programs,” said Thijs Spoor, the CEO of AzurRx. “Our current Phase II OPTION Study of MS1819-SD is progressing as planned, we have not seen any serious adverse events and the withdrawal rates have been low, which is compatible with, or below, other trials of synthetic enzymes. We remain on track to announce final data analysis of the OPTION Study in September 2019. Last month, we announced that we initiated a Phase 2 clinical trial to investigate MS1819-SD in combination with PERT, the existing standard of care for treating severe EPI in CF patients. That trial will focus on the clinical needs of the third of patients whose nutritional requirements cannot be met with PERT alone and we expect to announce preliminary data in early 2020. Our goal is to address the needs of CF patients by exploring the efficacy of both MS1819-SD replacement and combination therapies.”
During the second quarter, the Company announced that it acquired the intellectual property surrounding MS1819-SD. Mr. Spoor stated that, “Ownership of the patents to MS1819-SD further streamlines the project terms and more fully corresponds with our respective strategic and geographic objectives. We were also pleased to announce the Notices of Allowance in the U.S. and Japan for patents covering our MTAN inhibitor for treating H. pylori infections. We are excited to explore this indication as we believe that the MTAN technology has significant potential to reduce the number of H. pylori infections, and we plan to further develop the technology for narrow-spectrum anti-infectives against other diseases that have been prioritized by the WHO and the CDC. This expansion adds significant value to our portfolio of non-systemic, narrow spectrum therapeutic drugs that target gastrointestinal and bacterial infections and prevent dysbiosis in patients’ microbiomes.”
“Finally, AzurRx is pleased to report that we completed a public offering in July 2019 resulting in gross proceeds of $5 million, which consisted of straight equity and no warrants or other convertible instruments,” Mr. Spoor added.
Second Quarter 2019 Financial Results
Second quarter 2019 research and development expense increased to $2.7 million from $926 thousand in the second quarter of 2018. The second quarter increase was primarily due to increased development activities both for the MS1819-SD OPTION trial in the United States and Poland and the initiation of the MS1819-SD combination therapy study in Hungary.
General and administrative expense for the second quarter 2019 was approximately $2.2 million, compared with approximately $2.2 million in the second quarter of 2018.
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 PERT-based standard of care, does not contain any animal products.
In a Phase 2 trial of MS1819-SD in patients with chronic pancreatitis, MS1819-SD showed a favorable safety profile with good tolerability. Additionally, a statistically significant (p=0.002) improvement in the coefficient of fat absorption of 21.8% was observed at the highest studied dose (per protocol).
The Company is also currently conducting the OPTION Study, the Company’s Phase 2 multi-center study to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current PERT standard of care for EPI in CF patients. The Company recently announced the completion of patient enrollment in the OPTION Study, with top-line results expected late Summer 2019. AzurRx also recently started a combination study of MS1819-SD and PERT in CF patients who are not adequately treated with PERT therapy.
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. 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.
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, New York, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com.
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-SD 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
Brooklyn, NY 11226
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
250 West 55th Street - Suite 16B
New York, NY 10019