RedHill Biopharma Announces Expected Timeline for DSMB meeting and Provides Update on Enrollment in the RHB-104 Phase III Study for Crohn’s Disease

- The second independent Data and Safety Monitoring Board (DSMB) meeting of the RHB-104 Phase III study for Crohn’s disease (MAP US study) is planned to be held in late July 2017 and will assess the safety and efficacy of RHB-104 in the first 222 subjects who have completed week 26 assessments

- The DSMB meeting will include an interim efficacy analysis and an evaluation of an option for early stop for success for overwhelming efficacy; its recommendation is planned to be announced by early August 2017

- To date, approximately 300 patients of the planned total of 410 patients have been enrolled in the ongoing Phase III MAP US study

- The MAP US study is a randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s disease, with a primary endpoint of remission at week 26

- An ongoing open-label extension Phase III study (MAP US2 study) is evaluating the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the Phase III MAP US study and remain with active Crohn’s disease; these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the Phase III open-label extension study

TEL-AVIV, Israel and RALEIGH, N.C., July 13 (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 that the second independent Data and Safety Monitoring Board (DSMB) meeting of the RHB-104 Phase III study for Crohn’s disease (the MAP US study) is expected to convene in late July 2017 and will assess the safety and efficacy of RHB-104 in the first 222 subjects who have completed week 26 assessments. RedHill expects to announce the recommendation of the DSMB meeting by early August 2017.

Source : RedHill Biopharma Ltd.