MRM Health has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application, enabling the company to start the STARFISH-UC Phase IIb trial of MH002 in patients with mild-to-moderate ulcerative colitis (UC).
The clearance marks an important step for MRM Health’s lead programme focusing on microbiome-based therapeutics for inflammatory bowel diseases (IBD).
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The trial is a placebo-controlled, double-blind, randomised study and aims to confirm the efficacy signals and safety profile previously observed in Phase IIa studies of MH002.
MH002 is a rationally designed live microbial consortium composed of six well-characterised commensal strains, developed as a live biotherapeutic product targeting mechanisms specific to UC.
The study plans to enrol around 204 patients with mild-to-moderate ulcerative colitis who are not adequately managed by 5-aminosalicylic acid (5 ASA) with or without low-dose steroids.
The trial will be conducted in the US and Europe, starting with a 12-week, placebo-controlled induction phase that will assess two different dosing schedules. It will be followed by a 40-week open-label extension period. Patient recruitment is anticipated to commence around mid-2026.
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By GlobalDataA previous Phase IIa trial investigating MH002 in mild-to-moderate UC indicated good safety and promising efficacy after eight weeks of treatment, including induction of clinical remission, recovery of the gut microbiome, and signs of mucosal healing and anti-inflammatory effects.
No safety signals or adverse reactions were reported. In addition, MH002 demonstrated positive results in an open-label study for acute pouchitis.
MRM Health CEO Sam Possemiers said: “Receiving IND clearance from the FDA is a testament to MH002’s robust clinical foundation and its potential to transform the lives of those living with UC.
“The upcoming STARFISH-UC study is a critical next step in our mission to deliver a convenient, immune system-sparing, one-pill solution for IBD patients. We are excited to further validate MH002’s benefits and advance it as a frontrunner among innovative UC treatments.”
