MRM Health Receives FDA IND Clearance for Phase 2b Trial of MH002 Live Biotherapeutic in Ulcerative Colitis
核心洞察
MRM Health (搜索) secured FDA IND clearance to initiate the STARFISH-UC Phase 2b trial of MH002, a rationally-designed live microbial consortium for mild-to-moderate ulcerative colitis (搜索) treatment.
The randomized, placebo-controlled study will enroll approximately 204 patients inadequately controlled by standard care, featuring a 12-week induction phase followed by a 40-week extension.
Previous Phase 2a trials demonstrated excellent safety and encouraging efficacy signals, including mucosal healing, anti-inflammatory effects, and clinical remission induction.
MRM Health (搜索) NV announced that the U.S. Food and Drug Administration has granted clearance of its Investigational New Drug application for MH002, enabling the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis (搜索). This milestone marks a significant advancement in the development of next-generation therapies for inflammatory bowel diseases (搜索).
Advanced Live Biotherapeutic Product
MH002 represents the most advanced Live Biotherapeutic Product of its kind, based on a rationally-designed combination of disease-specific bacteria. The therapeutic targets disease-specific mechanisms through a synergistic combination of six well-characterized commensal strains, engineered using MRM Health (搜索)'s proprietary CORAL platform.
The CORAL platform enables the design and scalable cGMP manufacturing of complete microbial consortia as a single drug substance, offering regulatory and patient compliance advantages while supporting the development of cost-effective, high-quality therapeutics for chronic inflammatory conditions.
STARFISH-UC Phase 2b Trial Design
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. The study (NCT07296315) will enroll approximately 204 patients with mild-to-moderate ulcerative colitis (搜索) inadequately controlled by 5 aminosalicylic acid (搜索) with or without low-dose steroids, representing the current standard of care.
The trial will run across Europe and the U.S., 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.
Promising Early Clinical Results
Previous Phase 2a trials with MH002 in mild-to-moderate ulcerative colitis (搜索) demonstrated excellent safety and encouraging efficacy upon 8 weeks of treatment. The results indicated mucosal healing and anti-inflammatory effects, recovery of the gut microbiome (搜索), and induction of clinical remission. No safety signals or adverse reactions were observed during the study period.
Additionally, MH002 showed positive results in an open-label study for acute pouchitis (搜索), underscoring its broad therapeutic potential across inflammatory bowel disease indications.
Executive Perspective
"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 (搜索). "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."
Company Background and Funding
MRM Health (搜索) is a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology. In addition to advancing MH002 into pivotal clinical development in ulcerative colitis (搜索) and pouchitis (搜索), the company has ongoing preclinical programs in other inflammatory diseases and immune-oncology.
In September 2025, MRM Health (搜索) successfully closed a 55M€ Series B Round led by Biocodex, with strong support from ATHOS, BNP Paribas Fortis Private Equity and existing investors SFPIM, AvH, OMX Europe VF, QBic and VIB.