Microbiotica Completes Recruitment for Ulcerative Colitis Trial
Microbiotica has announced the completion of patient recruitment for its Phase 1b clinical trial, COMPOSER-1, which is evaluating its lead microbiome-based therapy, MB310, in adults with ulcerative colitis.
The study has successfully enrolled 29 patients across investigational sites in the United Kingdom, Austria, Bulgaria, Poland, and Spain, with initial results expected by the end of 2025.
A Precision Microbiome Approach
COMPOSER-1 is a randomised, placebo-controlled, double-blind trial designed to assess the safety, tolerability, and early efficacy signals of MB310. The trial also aims to determine how well MB310’s bacterial strains engraft into the gut microbiome of participants.
Patients with active, mild-to-moderate ulcerative colitis are receiving two oral capsules daily for 12 weeks, alongside standard care, followed by a 12-week observation period.
MB310 is a live biotherapeutic product containing eight gut commensal bacterial strains, specifically developed to induce long-term remission without relying on immunosuppression or causing significant side-effects.
The bacterial strains were identified through an in-depth analysis of clinical and microbiome data from a faecal microbiota transplant (FMT) study conducted with the University of Adelaide. Engrafting bacteria shown to be linked with positive clinical responses formed the basis for MB310’s formulation.
Scientific Rationale and Mechanisms
Preclinical studies suggest that MB310 works through three distinct mechanisms:
- Repairing the gut epithelial barrier to enhance intestinal integrity.
- Modulating inflammatory and immune cytokines to reduce gut inflammation.
- Inducing regulatory T-cell responses to help restore immune balance.
Ulcerative colitis, a chronic inflammatory bowel disease affecting over 1.4 million people globally, is often treated with long-term immunosuppressants, which can carry significant side-effects.
However, Microbiotica’s precision microbiome therapy aims to provide a targeted, long-lasting, and well-tolerated alternative.
Commitment to Advancing Care
Microbiotica’s Chief Medical Officer expressed delight at meeting recruitment targets on schedule, thanking both the investigational sites and participating patients for their contribution.
They noted the considerable body of evidence supporting FMT as a beneficial approach for mild-to-moderate ulcerative colitis, and voiced confidence that MB310’s design – based on specific, well-characterised bacterial strains – could deliver a precision microbiome-based treatment for this debilitating condition.
Looking Ahead
With recruitment now complete, Microbiotica is poised to analyse the safety, microbiome engraftment, and early efficacy data, which could pave the way for further clinical development.
If successful, MB310 may offer a new, targeted treatment paradigm for ulcerative colitis, one that leverages the power of the microbiome to bring sustained relief to patients worldwide.
News Credits: Microbiotica completes recruitment for phase 1b ulcerative colitis trial
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