RHB-104 Shows Promise for Crohn’s Disease Remission in Phase 3 Trial

RHB-104 Shows Promise for Crohn’s Disease Remission in Phase 3 Trial
RedHill Biopharma’s experimental therapy RHB-104 significantly increases the remission and response rates of patients with Crohn’s disease, according to top-line Phase 3 trial results recently announced by the company. The results, showing that the study met all primary and key secondary goals, were discussed in a conference call, which included a slide presentation. RHB-104 is an oral antibiotic combination therapy with potent anti-bacterial and anti-inflammatory properties, targeting a bacterial infection of Mycobacterium avium paratuberculosis (MAP), suspected to cause Crohn’s disease. The randomized, double-blind, placebo-controlled Phase 3 trial (NCT01951326), known as MAPUS, evaluated the safety and effectiveness of RHB-104 in people with moderate to severe Crohn’s disease, defined as Crohn’s Disease Activity Index (CDAI) between 220 and 450. The study’s primary goal was remission (no signs of active disease), defined as a reduction in CDAI of less than 150 at week 26. Secondary objectives included treatment response at week 26 (decrease in CDAI of at least 100 points), remission at week 16 and/or 52, and durable remission. The study involved 331 participants (ages 18-75) enrolled at over 100 sites in the U.S., Canada, Europe, Israel, Australia, and New Zealand. Partici
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