RedHill Biopharma Announces First Patient Dosed in the Open-Label Extension Study to the Phase III Study with RHB-104 for Crohn's Disease

• A first randomized, double-blind, placebo-controlled Phase III clinical study with RHB-104 for the treatment of Crohn's disease (the MAP US study) is ongoing in the U.S. and additional countries
   
• The open-label extension study (the MAP US2 study) is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the ongoing MAP US Phase III study and remain with active Crohn's disease (CDAI>150); these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label extension study
   
• The MAP US2 open-label extension study is considered separate from the ongoing MAP US Phase III study and data collected will be supplemental to the MAP US study data
   
• A second independent DSMB meeting for the MAP US Phase III study is expected in mid-2017, including an interim efficacy analysis and an evaluation of an option for early stop for success for overwhelming efficacy
   
• RHB-104 is a proprietary, orally-administered, potentially groundbreaking antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties

TEL-AVIV, Israel, March 21, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced dosing of the first patient in the open-label extension study to the Phase III study with RHB-104 for the treatment of Crohn's Disease (the MAP US study).

RHB-104 is a proprietary, orally-administered, potentially groundbreaking antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties.

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study, intended to evaluate the safety and efficacy of RHB-104 in patients with moderately to severely-active Crohn's disease (defined as Crohn's Disease Activity Index (CDAI) between 220 and 450). To date, 266 patients out of a planned total of 410 patients have been enrolled in the study, which is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. A long-term population pharmacokinetic (pop-PK) study is also ongoing as part of the MAP US study. Additional studies will be required to support a U.S. New Drug Application (NDA) for RHB-104.