Israeli company RedHill Biopharma Ltd. released final results from the Phase II clinical study with Bekinda 12 milligrams for treatment of diarrhea-predominant irritable bowel syndrome.
Here are five things you need to know:
1. RedHill is a biopharmaceutical company focused on late clinical-stage development and commercialization of proprietary drugs for GI diseases and cancer.
2. IBS is one of the most common GI disorders, affecting an estimated 30 million Americans; 40 percent of American cases are thought to be cases of IBS-D. The American market for IBS-D therapies grew by approximately 550 percent between 2013 and 2016.
3.The randomized, double-blind placebo-controlled Phase II study evaluated the efficacy and safety of Bekinda in 126 subjects over 18 years old in the U.S., who received either Bekinda or a placebo once a day for eight weeks.
4. Bekinda successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency according to FDA guidelines by an absolute difference of 20.7 percent compared to the placebo. Study results suggest that Bekinda compares favorably with reported efficacy outcome values from Xifaxan and Viberzi studies across all three efficacy endpoints.
5. RedHill plans to meet with the FDA in the first half of 2018 to discuss the design for Phase III studies with Bekinda for IBS-D.
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