RedHill Biopharma Announces Acceptance of Phase III Trial Application in Europe with RHB-104 for Crohn's Disease

TEL-AVIV, Israel, June 16, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. RDHL RDHL ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted RedHill's Clinical Trial Application (CTA) to initiate a second Phase III study of RHB-104 for Crohn's disease (the MAP EU study). The MAP EU study is planned to commence in a selected number of European counties, and, once initiated, will run in parallel with the currently ongoing MAP US first Phase III study. RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. The randomized, double-blind, placebo-controlled MAP EU Phase III study is expected to enroll 360 patients with moderately active Crohn's disease. Patients will be randomized 2:1 to receive either RHB-104 or a placebo for 52 weeks, and then evaluated for remission at week 26 as the primary endpoint. In addition, RHB-104 is currently undergoing a first Phase III study in the U.S., Canada, Israel, Australia, New Zealand and Europe (the MAP US study). The ongoing randomized, See full press release