MRM Health has announced that its lead candidate MH002 has been granted Fast Track designation by the FDA for the treatment of mild-to-moderate ulcerative colitis. The company describes MH002 as a rationally designed live biotherapeutic product composed of a consortium of six well-characterized commensal bacterial strains.
According to MRM Health, MH002 is currently the most advanced live biotherapeutic product targeting inflammatory bowel disease–specific mechanisms. The candidate is designed as an orally administered capsule for mild-to-moderate ulcerative colitis and pouchitis, with the aim of restoring microbiome balance, promoting mucosal healing and supporting immune rebalancing without immunosuppression.
The Fast Track designation was supported by data from a completed Phase 2a trial in mild-to-moderate ulcerative colitis. Over eight weeks of treatment, MH002 was reported to show an excellent safety profile and encouraging efficacy signals, including findings consistent with mucosal healing, anti-inflammatory activity, recovery of microbiome balance and induction of clinical remission. No safety signals or adverse reactions were observed in the study. MH002 also produced positive outcomes in an open-label study in acute pouchitis.
MRM Health plans to evaluate MH002 in a Phase 2b study (STARFISH-UC; NCT07296315) in patients with mild-to-moderate ulcerative colitis. The trial is expected to enroll approximately 204 patients and will include a 12-week induction phase comparing two MH002 dosing regimens with placebo, followed by a 40-week open-label extension phase at sites in Europe and the United States.
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