=RedHill Biopharma (RDHL): bowel syndrome drug study meets main goal

RedHill Biopharma announces positive top-line results from the Phase II clinical study of BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome

BEKINDA 12 mg Phase II study successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency response (per FDA guidance definition) by an absolute difference of 19.4%, with 54.7% responders of subjects treated with BEKINDA (n=75) vs. 35.3% responders of the placebo subjects (n=51) (p = 0.05). These top-line results compare favorably with previously reported efficacy outcome values for stool consistency response from two Phase III studies of Xifaxan (rifaximin) 550 mg (averaged absolute difference from Trial 1 and Trial 2 of 10.5%) and two Phase III studies of Viberzi 100 mg (eluxadoline) (averaged absolute difference of 13.5%).

• BEKINDA 12 mg was also shown to be safe and well tolerated. No serious adverse events, new or unexpected safety issues were noted in the study, suggesting the potential of BEKINDA 12 mg, if approved, to become a first-line standard of care treatment for IBS-D.
• RedHill will continue to analyze the data from the Phase II study with BEKINDA 12 mg, including all secondary endpoints. RedHill is also analyzing drug allocation and pharmacokinetics in the study, including some aberrant findings which are not expected to have a material impact on the final results. The top-line results were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report (CSR), expected in the first quarter of 2018. Detailed results from the Phase II study will be submitted for presentation at upcoming scientific conferences.

In addition to the BEKINDA 12 mg Phase II IBS-D program, RedHill announced in June 2017 positive top-line results from the Phase III GUARD study with BEKINDA 24 mg. The Phase III GUARD study successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA 24 mg was found to be safe and well tolerated in this indication. RedHill recently met with the FDA to discuss the results of the Phase III GUARD study and the clinical and regulatory path towards potential marketing approval of BEKINDA 24 mg in the U.S. Following the positive guidance meeting, the Company is currently working with the FDA to design the confirmatory Phase III study to support a New Drug Application (NDA) with BEKINDA 24 mg for acute gastroenteritis and gastritis.