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RedHill has initiated the patient screening process in a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the safety and efficacy of RHB-104 for treatment of Crohn's disease (the MAP US study)
The Phase III study is expected to enroll 240 subjects in approximately 50 clinical sites in the U.S., Canada and Israel. Subjects will be treated for 52 weeks with a primary endpoint of remission at week 26
An independent board (DSMB) will review safety throughout the study and perform a futility analysis when half the subjects complete the first 26 weeks of blinded treatment
A second Phase III study for Crohn's disease in Europe (the MAP Europe study) is planned to commence in the first half of 2014 so that the two studies will be conducted in parallel
TEL-AVIV, Israel, Oct. 1, 2013 (GLOBE NEWSWIRE)
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that it has initiated the patient screening process in the MAP US study, a Phase III clinical study designed to evaluate the safety and efficacy of fixed-dose RHB-104 in patients with moderately to severely active Crohn's disease.
RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral pill formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.
RHB-104 is based on increasing evidence supporting the hypothesis that Crohn's disease is caused by the
Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients rather than being an autoimmune disease.
The randomized, double-blind, placebo-controlled Phase III clinical study is expected to enroll 240 subjects with moderately to severely active Crohn's disease in approximately 50 clinical sites in the U.S., Canada and Israel.