RedHill Biopharma Ltd. announced top-line final results1 from the Phase II clinical study with BEKINDA® 12 mg (RHB-102)2 for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). An independent review and analysis of the final results, provided to the Company, confirmed that the Phase II study with BEKINDA® 12 mg successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency (per FDA guidance definition) by an absolute difference of 20.7% vs. placebo (p-value=0.036). The final top-line results improve upon the previously announced top-line results (absolute difference of 19.4%, p-value=0.05). Results from the BEKINDA® 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 endpoints3. The randomized, double-blind, placebo-controlled Phase II study evaluated the efficacy and safety of BEKINDA® 12 mg in 126 subjects over 18 years old in the U.S., who received either BEKINDA® 12 mg or placebo, once daily, for a period of eight weeks. IBS is one of the most common gastrointestinal disorders4, affecting an estimated 30 million Americans, of which approximately 40% are estimated to be cases of IBS-D5; The U.S. market of IBS-D therapies grew by approximately 550% between 2013-20166. RedHill plans to meet with the FDA in the first half of 2018 to discuss the design for one or two pivotal Phase III studies with BEKINDA® 12 mg for IBS-D.