- 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
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.
The independent DSMB meeting will conduct safety and interim efficacy analyses and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold for overwhelming efficacy of RHB-104 versus placebo at the primary endpoint (two-sided p-value<0.003). 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. Assuming the study is not stopped for success or inefficacy following the DSMB meeting, completion of recruitment for the MAP US study is expected by the beginning of 2018.
Additionally, the Company updated that it has completed the enrollment of approximately 300 out of the 410 subjects planned to be enrolled in the RHB-104 Phase III study for Crohn’s Disease (the MAP US study).
RHB-104 is a proprietary, orally-administered, potentially groundbreaking, 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.
In December 2016, a first pre-planned independent DSMB meeting reviewed safety data from the ongoing MAP US study and provided a unanimous recommendation to continue the study as planned. Assuming the Phase III MAP US study is not stopped early, a third, safety-focused, independent DSMB meeting will be held once 75% of the 410 patients planned to be enrolled in the study will have completed 26 weeks of study participation.
RedHill recently initiated an open-label extension Phase III study (MAP US2 study) to the first Phase III MAP US study with RH...
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