The conference call, including a slide presentation, will be broadcasted live and available for replay on the Company's website, for 30 days.Please access the Company's website at least 15 minutes ahead of the conference call to register, download, and install any necessary audio software.At the second DSMB meeting, held in July 2017, safety and efficacy data from the first 222 subjects who had completed week 26 assessments of the study was reviewed.In addition, an open-label extension Phase III study (the MAP US2 study) continues to evaluate the safety and efficacy of RHB-104 in subjects who remain with active Crohn’s disease (CDAI ≥ 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study.Additional clinical studies are likely to be required to support a U. Two pre-planned independent DSMB meetings were held to review data from the MAP US study in which unanimous recommendations to continue the study without any changes to the protocol, investigator’s brochure, study conduct or informed consent form were given.
Upon discussion with internal and external experts, we have concluded that the study has sufficient enrollment to potentially demonstrate efficacy within the protocol-defined 15% treatment effect (RHB-104 36% vs. The blended remission rate of the currently blinded data has been consistently within or superior to our pre-specified protocol defined assumptions, indicating potential study success at the curtailed sample size of approximately 325 subjects, assuming the placebo and RHB-104 remission rates in our study are in line with trial assumptions. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“Red Hill” 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. 02, 2017 (GLOBE NEWSWIRE) -- Red Hill Biopharma Ltd.Red Hill also continues to advance the development program for a commercial companion diagnostic for the detection of MAP bacteria in Crohn’s disease patients, in collaboration with several U. The development of the commercial companion diagnostic is an extension of Red Hill's RHB-104 Phase III development program.There is currently no validated, FDA-approved, commercially-available method of detecting the presence or absence of MAP in patients suffering from Crohn's disease or other diseases.