MRM Health receives US FDA IND clearance to initiate phase 2b trial of MH002 in mild-to-moderate ulcerative colitis

"MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, announced that the US Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead programme MH002. This enables the initiation of the STARFISH-UC phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD).

The STARFISH-UC trial is a randomized, double-blind, placebo-controlled study designed to confirm the promising efficacy signals and favorable safety profile previously observed in MH002’s phase 2a studies. MH002, a rationally designed live microbial consortium, is the most advanced Live Biotherapeutic Product (LBP) of its kind, targeting disease-specific mechanisms through a synergistic combination of six well-characterized commensal strains. The study (NCT07296315) will enroll approximately 204 patients with mild-to-moderate ulcerative colitis (UC) inadequately controlled by 5 aminosalicylic acid (5 ASA) with or without low-dose steroids, the current standard of care. The trial will run across Europe and the US, featuring a 12-week placebo-controlled induction phase with two dosing regimens, followed by a 40-week open-label extension. Enrollment is expected to begin mid-2026.

A previous phase 2a trial with MH002 in mild-to-moderate UC suggested excellent safety and encouraging efficacy upon 8 weeks of treatment, indicative of mucosal healing and anti-inflammatory effects, recovery of the gut microbiome and induction of clinical remission. No safety signals or adverse reactions were observed. Additionally, MH002 showed positive results in an open-label study for acute pouchitis, underscoring its broad therapeutic potential. 

“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,” stated Sam Possemiers, CEO of MRM Health. “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.”

MH002 is engineered using MRM Health’s proprietary CORAL platform, which enables the design and scalable cGMP manufacturing of complete microbial consortia as a single drug substance. This approach offers regulatory and patient compliance advantages, supporting the development of cost-effective, high-quality therapeutics for chronic inflammatory conditions.

MRM Health is a clinical-stage biotech developing innovative microbiome-based live biotherapeutic products for chronic inflammatory diseases with high unmet need. Its CORAL platform enables the design and manufacture of disease-focused microbial consortia with enhanced efficacy and scalability.

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