AzurRx BioPharma Announces Completion of Enrollment in Phase 2 Clinical Trial of MS1819 in Combination with PERT in the Treatment of Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

Top-line data expected in Q2 2021

DELRAY BEACH, Fla., March 22, 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, today announced it has completed enrollment in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

“We are very pleased to have completed enrollment in our Phase 2 MS1819 plus PERT combination therapy clinical trial,” said James Sapirstein, President, CEO and Chairman of AzurRx. “Based on the very encouraging clinical results to date, we believe that the combination therapy has significant potential to help the 25-30% of refractory cystic fibrosis patients with severe EPI who are unable to achieve adequate nutrition using PERT alone. Adding a small dose of MS1819 can help these patients meet their nutritional needs, reduce the debilitating symptoms of EPI and improve their overall quality of life, with an increased safety profile.”

Mr. Sapirstein continued, “The combination therapy program represents a second therapeutic opportunity for the MS1819 program. We reported the completion of enrollment of our Phase 2 monotherapy program – OPTION 2 – last week and will announce topline results for that trial at the end of March. We continue to remain on target to report topline results from the combination therapy study during the second quarter of 2021.”

“The overarching goal of our MS1819 program is to provide a safe and effective therapy to control EPI, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can result in numerous, life-altering complications, including malnutrition,” added Dr. James Pennington, Chief Medical Officer of AzurRx. “Early clinical evidence has been promising, and with the combination and OPTION 2 monotherapy trials progressing, we may soon have the opportunity to introduce a drug product that could potentially improve the lives of thousands of patients suffering from cystic fibrosis.”