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-bacterial and anti-inflammatory properties. RedHill developed it after studies showed that Crohn’s may stem from Mycobacterium avium subspecies paratuberculosis, or MAP, infections. That research has indicated that MAP infections may disrupt normal immune functioning, triggering the development of autoimmune diseases. “RHB-104 is a potentially ground-breaking new t
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