AzurRx BioPharma to Report Topline Data from Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis

AzurRx to Host Conference Call and Live Audio Webcast Today, Wednesday, March 31, 2021 at 4:30 p.m. ET

DELRAY BEACH, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that the Company will host a conference call and live audio webcast today, Wednesday, March 31, 2021, at 4:30 p.m. ET, to discuss the topline results from its Phase 2b OPTION 2 clinical trial investigating MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).

Interested participants and investors may access the conference call by dialing either:

• [phone] (U.S.)
• [phone] (international)
• Conference ID: 5145118
  

OPTION 2 was designed as a Phase 2b multi-center study to investigate the safety, tolerability and efficacy of MS1819 (in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint was the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). The trial also included an extension arm that used an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

An audio webcast of the conference call will be accessible via the Investors section of the AzurRx website https://azurrx.com/. An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on March 31, 2021.

Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial was 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 was 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 were enrolled. MS1819 was administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients were first randomized into two cohorts: to either the MS1819 arm, where they received a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of coefficient of fat absorption. Patients were then crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.