MRM Health, a clinical-stage biopharmaceutical company focused on microbiome-based therapies, has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application covering MH002, its lead investigational therapy for ulcerative colitis. The clearance allows MRM Health to initiate the STARFISH-UC Phase 2b clinical trial, a multicentre study evaluating MH002 in patients with mild-to-moderate ulcerative colitis whose disease is inadequately controlled with standard 5-aminosalicylic acid therapy, with or without low-dose corticosteroids. The development marks an important progression in the company’s efforts to expand treatment options for inflammatory bowel disease.
The STARFISH-UC study is designed as a randomized, double-blind, placebo-controlled trial enrolling approximately 204 patients across sites in Europe and the United States. The study will include a 12-week placebo-controlled induction phase evaluating two dosing regimens, followed by a 40-week open-label extension to assess longer-term safety and treatment durability. Patient enrollment is expected to begin in mid-2026.
MH002 is a rationally designed live biotherapeutic product composed of six well-characterised commensal bacterial strains selected to act synergistically on disease-relevant pathways. The therapy is intended to address underlying inflammatory mechanisms while supporting restoration of gut microbial balance.
Earlier Phase 2a data in mild-to-moderate ulcerative colitis demonstrated a favourable safety profile alongside signals of clinical activity following eight weeks of treatment. Observations included indications of mucosal healing, reduction of inflammatory markers, restoration of microbiome composition, and achievement of clinical remission in a subset of patients. No treatment-related safety concerns were reported. MH002 has also shown encouraging results in an open-label study in patients with acute pouchitis.
Commenting on the milestone, Sam Possemiers, Chief Executive Officer of MRM Health, said the FDA clearance reflects the strength of the clinical data generated to date and supports further evaluation of MH002 as a potential oral, immune-sparing therapeutic option for ulcerative colitis.
MH002 is developed using MRM Health’s proprietary CORAL® platform, which enables the design and scalable cGMP manufacturing of defined microbial consortia as a single drug substance. The platform supports consistency, regulatory alignment, and patient convenience, particularly for chronic inflammatory conditions.
