MRM Health NV, a clinical-stage biopharma company, has announced that the US FDA has cleared its Investigational New Drug (IND) application for its groundbreaking therapy to treat patients with ulcerative colitis.

 

The clearance for MH002 paves the way for the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis (UC), a major milestone in the pursuit of next-generation treatments for inflammatory bowel disease (IBD).

 

The STARFISH-UC trial is a randomized, double-blind, placebo-controlled study aimed at confirming the promising efficacy and safety signals observed in earlier Phase 2a studies. 

 

MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms. The trial will enroll approximately 204 UC patients whose disease is inadequately controlled by standard therapy, including 5-aminosalicylic acid with or without low-dose steroids. 

 

Conducted across Europe and the US, the study features 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.

 

Earlier Phase 2a data for MH002 demonstrated excellent safety and encouraging efficacy after eight weeks of treatment, including evidence of mucosal healing, anti-inflammatory effects, microbiome recovery, and clinical remission. No safety concerns were reported.

 

“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,” said 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.”