RedHill Biopharma Ltd 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, reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.
The independent DSMB reviewed safety and efficacy data, of which RedHill remains blinded, from the first 222 subjects who have completed week 26 assessments in the Phase III MAP US study. In December 2016, a first pre-planned independent DSMB meeting reviewed safety data from the MAP US study and provided a unanimous recommendation to continue the study as planned.
Ira Kalfus, MD, Medical Director at RedHill, said: “RHB-104 is a potentially ground-breaking new therapy for Crohn’s disease. The DSMB has reviewed the unblinded interim safety and activity results of the Phase III MAP US study, and we are very encouraged by its unanimous recommendation to continue the study through randomization of all planned 410 subjects, with no changes to the protocol, investigator’s brochure, study conduct or informed consent form. We continue to enroll subjects and expect to complete enrollment in the study in the first half of 2018. I would like to thank the DSMB members for their professional and independent assessment of the study data and for their positive recommendation.”
RHB-104 is a proprietary, orally-administered, potentially ground-breaking, antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties, targeting a suspected underlying bacterial infectious cause of Crohn’s disease, Mycobacterium avium subspecies paratuberculosis (MAP).
The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s disease (defined as CDAI between 220 and 450). The MAP US study is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. Additional clinical data will need to be generated to support a U.S. New Drug Application (NDA) for RHB-104. The primary endpoint of the MAP US study is disease remission, defined as a reduction in Crohn’s Disease Activity Index (CDAI) to less than 150 at week 26.
To date, over 300 of the planned 410 subjects, have been randomized in the MAP US study. A third, safety-focused, independent DSMB meeting is expected to be held when 75% of the planned 410 subjects have completed 26 weeks of study participation. Completion of recruitment for the MAP US study is expected in the first half of 2018.
Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to further assess the safety and efficacy of RHB-104 in patients who remain out of remission (CDAI ≥ 150) after 26 weeks of blinded study therapy in the ongoing Phase III MAP US study.
