Benzinga | Aug 17, 2020 08:02AM EDT

AzurRx BioPharma Initiates European Arm Of Phase 2b OPTION 2 Clinical Trial Of MS1819 In Cystic Fibrosis

* Three clinical trial sites activated in Poland, with patient screening initiated

* Follows activation of six clinical sites in the U.S. and dosing of first three patients

* Topline data expected in Q1 2021

NEW YORK, Aug. 17, 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 its initial European trial sites are active and screening patients for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). A total of nine of the expected fifteen sites globally are now active and recruiting patients. Top line data from the study are anticipated in Q1 2021.



"We are moving forward swiftly with our OPTION 2 clinical trial and are pleased to have activated the first three European clinical trials sites in Poland," said Dr. James Pennington, Chief Medical Officer of AzurRx. "We now have nine clinical sites activated globally, six of which are in the U.S., and are optimistic that all fifteen clinical trial sites will be screening patients in September. With our first three patients dosed already, we anticipate having top line data from this trial in Q1 2021 as expected."

James Sapirstein, Chief Executive Officer of AzurRx, added, "Our team is successfully advancing both of our MS1819 clinical programs and actively initiating new clinical trial sites and screening and enrolling patients. We look forward to the successful completion of the OPTION 2 monotherapy trial and the Combination therapy trial in 2021."

Phase 2b OPTION 2 Trial Design

The Phase 2b OPTION 2 multi-center trial is 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 primary efficacy endpoint is the coefficient of fat absorption (CFA).



It will be an open-label, crossover study, conducted in15sites in the U.S. and Europe. A total of30CF patients 18 years or older will be enrolled.

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