MRM Health NV, a clinical-stage biopharmaceutical company developing microbiome-based therapeutics, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its lead program MH002.
The clearance enables the initiation of the STARFISH-UC Phase 2b trial in patients with mild-to-moderate ulcerative colitis (UC), marking a key step in advancing next-generation treatments for inflammatory bowel disease (IBD).
MH002 is a rationally designed Live Biotherapeutic Product (LBP) composed of six well-characterized bacterial strains, targeting disease-specific mechanisms in UC. The STARFISH-UC study is a randomized, double-blind, placebo-controlled trial enrolling approximately 204 patients whose disease is inadequately controlled by standard therapy, including 5-aminosalicylic acid with or without low-dose steroids.
The trial will run across Europe and the U.S., with a 12-week placebo-controlled induction phase featuring two dosing regimens, followed by a 40-week open-label extension. Enrollment is expected to begin mid-2026.
Results from the previous Phase 2a trial demonstrated MH002’s favorable safety profile and encouraging efficacy, including evidence of mucosal healing, microbiome restoration, and clinical remission. MH002 also showed positive outcomes in an open-label study for acute pouchitis, highlighting its broader therapeutic potential.
MH002 is manufactured using MRM Health’s proprietary CORAL® platform, enabling scalable production of complete microbial consortia as a single drug substance, supporting regulatory compliance, patient adherence, and cost-effective production.
MRM Health continues to advance its microbiome-based pipeline for chronic inflammatory diseases, with MH002 moving into pivotal clinical development for UC and pouchitis.
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