Benzinga | Nov 17, 2020 08:03AM EST

AzurRx BioPharma Reports Will Submit Protocol Amendment Request To FDA For Its Phase 2b OPTION 2 Trial Of MS1819 For Treatment Of Exocrine Pancreatic Insufficiency In Patients With Cystic Fibrosis

AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be submitting a protocol amendment request to the U.S. Food and Drug Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. The proposed amendment will add a study arm that uses 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.

"We are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed," said Dr. James Pennington, Chief Medical Officer of AzurRx. "As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819."

Dr. Pennington added, "The key objectives of any Phase 2 program are to test for safety and efficacy, but another important goal is to determine appropriate doses and drug delivery method prior to entering the Phase 3 portion of the clinical program. If the amendment is accepted by the FDA, we anticipate enrollment into the new study arm to begin in December 2020."

James Sapirstein, CEO of AzurRx commented, "The protocol amendment represents an opportunity to gain valuable additional clinical data with no significant increase in overall trial costs or delays to our timeline projections. We remain on target to release top line data in the first quarter of 2021, as has been our guidance to date."