Wednesday, October 4, 2017

RedHill Biopharma Accelerates RHB-104 Phase III Study in Crohn’s Disease with Top-Line Results Expected Mid-2018

TEL-AVIV, Israel and RALEIGH, N.C., Oct 3 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the Company has accelerated the timelines for the ongoing first Phase III study with RHB-104 for Crohn’s disease (MAP US) by curtailing the number of subjects planned to be enrolled in the study from 410 to approximately 325 subjects.

Given that 322 subjects have been enrolled in the MAP US Phase III study to date, the Company expects to complete enrollment by November 2017 and to announce top-line results in mid-2018. RedHill remains blinded to the ongoing data from the study. The protocol amendment implementing the curtailment strategy has been filed with the FDA and healthcare regulators in other relevant countries.


Source : RedHill Biopharma Ltd.

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