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First patient has been recruited and dosed in the MAP US study - 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 Phase III study is expected to enroll 240 subjects in over 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 data and safety monitoring board (DSMB) will perform a futility analysis when half the subjects complete the first 26 weeks of blinded treatment
TEL-AVIV, Israel, Nov. 25, 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 the first patient has been recruited and dosed 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 capsule 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.
"RHB-104 presents a new and innovative approach to treating Crohn's disease, as it targets a specific pathogen believed to be the cause for the disease, rather than targeting only the symptoms like most standard therapies. We believe that RHB-104 is uniquely positioned due to its dual antibiotic and anti-inflammatory properties,"
said Ira Kalfus MD, RedHill's Medical Director. "Our efforts are currently focused on subject recruitment, and we are excited by the level of interest in this study by both investigators and patients."
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 over 50 clinical sites in the U.S., Canada and Israel. Subjects are randomized 1:1 to receive up to five capsules of either RHB-104 or the placebo twice daily for 52 weeks and will be assessed for remission at 26 weeks. Unblinding and assessment of primary and secondary endpoints will be performed after all subjects complete the study.