RedHill's Bekinda meets in Phase II for IBS-D

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) reported top-line data from a Phase II trial in 126 patients with irritable bowel syndrome with diarrhea (IBS-D) showing that once-daily 12 mg oral Bekinda ondansetron met the primary endpoint of a greater proportion of stool consistency responders vs. placebo (54.7% vs. 35.3%, p=0.05). On secondary endpoints, Bekinda led to a worst overall abdominal response rate of 50.7% vs. 39.2% for placebo (p=0.28). The overall response rate (ORR), a composite measure of stool consistency and abdominal pain response, was 41.3% in patients treated with Bekinda vs. 25.5% for placebo (p=0.1). RedHill said the secondary endpoints were not powered for significance. Bekinda was well tolerated with no serious adverse events reported in the double-blind, U.S. trial. The company expects to report additional data next quarter.

RedHill plans to meet with FDA by early 2018 to discuss next steps for the 12 mg dose of Bekinda to treat IBS-D. The company is also planning a confirmatory Phase III trial to support an NDA for a 24 mg dose of Bekinda to treat acute gastroenteritis and gastritis, following positive data from the Phase III GUARD trial (see BioCentury, June 30)...