RedHill Biopharma Announces Final Results from Phase II Study

RedHill Biopharma Ltd. recently announced top-line final results from the Phase II clinical study with BEKINDA 12 mg (RHB-102) 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 endpoints.

– 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 US, who received either BEKINDA 12 mg or placebo, once daily, for a period of 8 weeks.

– IBS is one of the most common gastrointestinal disorders, affecting an estimated 30 million Americans, of which approximately 40% are estimated to be cases of IBS-D. The US market of IBS-D therapies grew by approximately 550% between 2013-2016.

– 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.

BEKINDA is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. A Phase III clinical study with BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) successfully met its primary endpoint. A Phase II study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) also successfully met its primary endpoint.

RedHill Biopharma Ltd. is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases, and cancer. RedHill promotes three gastrointestinal products in the US: Donnatal – a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg – a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions; and EnteraGam® – a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s key clinical-stage development programs include: (i) TALICIA (RHB-105) – an oral combination therapy for the treatment of Helicobacter pylori infection with an ongoing confirmatory Phase III study and successful results from a first Phase III study; (ii) RHB-104 – an oral combination therapy with an ongoing first Phase III study for Crohn’s disease and a planned pivotal Phase III study for nontuberculous mycobacteria infections(NTM); (iii) YELIVA (ABC294640) – an orally administered, first-in-class SK2 selective inhibitor with an ongoing Phase IIa study for cholangiocarcinoma; (iv) BEKINDA (RHB-102) – a once-daily oral pill formulation of ondansetron with positive final results from a Phase III study in acute gastroenteritis and gastritis and positive top-line final results from a Phase II study in IBS-D; (v) RHB-106 – an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vi) RHB-107 (MESUPRON) – a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and inflammatory gastrointestinal diseases. For more information, visit www.redhillbio.com.