AzurRx BioPharma to Report Topline Data from Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis
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:
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
About Exocrine Pancreatic Insufficiency
There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.
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