RedHill Biopharma Wraps Up Recruitment for Phase 3 Trial of RHB-104 for Crohn’s

RedHill Biopharma Wraps Up Recruitment for Phase 3 Trial of RHB-104 for Crohn’s
RedHill Biopharma has finished recruiting the 331 participants it wanted for a Phase 3 clinical trial of RHB-104 as a treatment for Crohn's disease. About two-thirds of the participants have already completed the study, the company announced. RHB-104 is an oral antibiotic combination therapy with potent anti-bacterial and anti-inflammatory properties. It is based on the premise that a bacteria causes the immune system dysfunction in Crohn’s disease. Scientists have identified the potential culprit as the Mycobacterium avium species paratuberculosis, or MAP. The placebo-controlled MAP US Phase 3 trial (NCT01951326) continues to evaluate the safety and effectiveness of RHB-104 in people with moderate to severe Crohn’s. The primary objective of the study is to put the disease into remission, which researchers define as a Crohn’s Disease Active Index score of less than 150 at week 26. RedHill expects the full trial results in mid-2018. Researchers have enrolled trial participants at 150 sites in the United States, Canada, Israel, Australia, New Zealand, Bulgaria, the Czech Republic, Poland, Serbia, and Slovakia. Patients receive five capsules a day of RHB-104 or a placebo. An independent review panel, the Data and Safety Monitoring Board, has recommended that RedHill make no changes
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