Research Update The U.S. Food and Drug Administration (FDA) has formally cleared the Investigational New Drug (IND) application for MH002, enabling MRM Health to initiate the Phase IIb STARFISH-UC trial. This milestone marks a critical step in advancing microbiome-based biotherapeutics designed to treat ulcerative colitis (UC).
Key Trial Facts:
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Target Population: The study focuses on approximately 204 patients with mild-to-moderate UC who have not responded adequately to standard treatments, such as 5-aminosalicylic acid (5-ASA).
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Product Profile: MH002 is a rationally designed consortium of six well-characterized commensal bacterial strains. It is developed as a live biotherapeutic product intended to offer an immune-sparing, convenient “one-pill” solution for inflammatory bowel disease (IBD).
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Study Design: The trial will be conducted across the U.S. and Europe, featuring a 12-week placebo-controlled induction phase to evaluate two dosing schedules, followed by a 40-week open-label extension. Recruitment is slated to begin around mid-2026.
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Clinical Foundation: Prior Phase IIa data indicated that MH002 is well-tolerated and shows promising signs of mucosal healing and gut microbiome recovery, with no significant safety signals or adverse reactions reported.
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Strategic Vision: MRM Health leadership aims to position MH002 as a frontrunner in innovative UC care, providing a personalized and effective alternative for patients seeking long-term disease management.