Benzinga | Aug 13, 2020 08:01AM EDT

AzurRx BioPharma Announces First Patients Dosed in Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis

* First three patients enrolled in dose escalation trial using delayed-release enteric capsules

* Topline data expected in 1H 2021

NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinanttherapies forgastrointestinal diseases, today announced that is has enrolled the first three patients in its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial will enroll approximately 30 CF patients with top line data from the study anticipated in 1H 2021.

The Phase 2b multi-center study is designed to investigate the safety, tolerability, and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA).

"Enrolling the first patient in our Phase 2b OPTION 2 trial is an important milestone and we appreciate the support from our clinical trial specialists and centers. We are optimistic that our delayed-release delivery of MS1819 will achieve our primary and secondary efficacy endpoints in this study," said Dr. James Pennington, Chief Medical Officer of AzurRx. "We anticipate data from this trial will inform the optimal dose for our pivotal Phase 3 study, and look forward to top line results in the first quarter of next year."

James Sapirstein, Chief Executive Officer of AzurRx, added, "We are very pleased to announce that patient dosing in the OPTION 2 trial has begun in the U.S. This represents an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis. Despite the challenges posed by the COVID-19 pandemic, the AzurRx team has been able to successfully activate new clinical trial sites and work with investigators to safely admit patients into the trial."