RedHill set to progress Bekinda after Phase II meeting with FDA

Israeli gastrointestinal focused biotech firm RedHill Biopharma (TASE: RDHL) says that it recently concluded a positive end-of-phase II/pre-phase III (Type B) meeting with the US Food and Drug Administration discussing the clinical and regulatory pathway towards potential US approval of Bekinda (RHB-102)for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

In light of the clarity provided by the FDA, RedHill plans to finalize the design of two pivotal Phase III studies with Bekinda, an extended-release formulation of the antiemetic drug ondansetron, and to accelerate global pharma partnership discussions, including US co-promotion opportunities, with the news sending RedHill’s shares up 7% in pre-market trading on Wednesday.

The FDA meeting followed the positive results of the randomized, double-blind, placebo-controlled Phase II study with Bekinda for IBS-D. The study, which was conducted in the USA and enrolled 126 subjects, successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency response (per FDA guidance definition) by an absolute difference of 20.7% versus placebo (p = 0.036). Results from the Phase II study suggest that they compare favorably with previously reported efficacy outcome values from studies of Xifaxan(rifaximin) and Viberzi(eluxadoline) across all three efficacy endpoints.