Phase 3 Trial of RHB-104 as Combination Therapy for Moderate to Severe Crohn’s Is on Track, Review Board Says

Phase 3 Trial of RHB-104 as Combination Therapy for Moderate to Severe Crohn’s Is on Track, Review Board Says
An independent review board has confirmed the preliminary findings of a Phase 3 clinical trial showing that RHB-104 is a safe and effective combination treatment for Crohn’s disease. The Data and Safety Monitoring Board recommended unanimously that the trial continue as planned, according to RHB-104's developer, RedHill Biopharma. It's the second time a board has reviewed the MAP US study. The first time, in December 2016, it also made a unanimous recommendation that the study continue. This time the board had to decide if the RHB-104 combo was achieving a certain level of effectiveness, compared with a placebo. It agreed that the therapy was. The MAP US study (NCT01951326) is evaluating the safety and effectiveness of a combination of RHB-104 and other therapies in patients with moderate to severe Crohn's disease. The study’s primary objective is for patients to achieve remission — that is, eliminate signs of the disease — within 26 weeks. Besides RHB-104, the combination includes clarithromycin, rifabutin and clofazimine. So far, 222 people have completed the 26-week assessment. Overall, 300 of what RedHill hopes to be 410 subjects have been randomized to receive either RHB-104 or a placebo. Researchers are still recruiting participants in up to 150 trial sites in the United States, Canada, Israel, Australia, New Zealand and some European countries. RHB-104 has anti-b
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