RedHill Biopharma provides progress update on RHB-104 Phase III program
RedHill Biopharma provided an update on the RHB-104 Phase III Crohn's disease development program, planned enhancements to the MAP US first Phase III study and expected milestones, including an option for early stop for success for overwhelming efficacy. An option for early stop for success for overwhelming efficacy has been introduced into the ongoing first Phase III study with RHB-104 for Crohn's disease and analysis is expected in the second quarter of 2017 as part of a second independent data safety and monitoring board interim safety and efficacy review; The introduction of an early stop for success option may provide an opportunity to significantly shorten the time for study completion. An independent safety-focused DSMB meeting for the Phase III MAP US study is on track for the fourth quarter of 2016. Ongoing work on RedHill's companion MAP diagnostic test has led to the successful identification of MAP DNA in blood samples from Crohn's disease patients; Further development work on the MAP companion diagnostic is in progress; RedHill has recently entered into a collaboration with Baylor College of Medicine - RedHill's third such MAP diagnostics collaboration with a leading U.S. university.