Microbiotica begins human trials for ulcerative colitis treatment

First patient dosed in phase 1b trial of MB310 therapy

Microbiotica, a clinical-stage biopharma company, has announced the dosing of the first patient in its Phase 1b First-in-Human trial, COMPOSER-1, for MB310 in ulcerative colitis (UC) patients.

This international trial aims to recruit up to 30 adult patients across the UK, Austria, Bulgaria, Poland, and Spain. Initial data readouts are expected by the end of 2025.

Ulcerative colitis, an inflammatory bowel disease, affects over 1.4 million people globally. MB310, developed as an oral capsule dosed once daily, contains a consortium of eight live gut commensal bacterial strains designed to deliver long-term remission without immunosuppression or unwanted side effects.

The COMPOSER-1 study will assess the safety, tolerability, and initial efficacy signals of MB310 in a randomised, placebo-controlled, double-blind clinical trial.

The trial will measure the engraftment success of the bacteria within MB310 into patients’ intestinal microbial community.

Patients with active, mild-to-moderate UC will take two capsules of the study medication (active or placebo) daily for 12 weeks, alongside their standard medication, followed by a 12-week follow-up period.

Professor Walter Reinisch, a principal investigator in the study, said, “Microbiota dysregulation is known to be a key driver to the pathogenesis in ulcerative colitis. The COMPOSER-1 study offers us a unique opportunity to treat UC by rebalancing the microbiota with this new treatment modality and potentially inducing long-term disease remission in our patients.”

Ron Carter, Microbiotica’s Chief Medical Officer, added, “There is a considerable body of evidence to support that FMT is beneficial for mild-to-moderate UC patients. This provides the underpinning of a microbiome-based treatment for this debilitating disease.”

He added: “Microbiotica’s precision microbiome platform has enabled us to identify the specific bacteria that could make a difference for patients and deliver them as a pharmaceutical in the form of MB310.”

Microbiotica’s MB310 was developed by analysing clinical and microbiome data from a faecal microbiota transplant (FMT) study. Preclinical studies have demonstrated MB310’s ability to promote gut healing, regulate cytokine balance, and induce a regulatory T-cell response. The company hopes that this trial will pave the way for a new, effective treatment for UC patients.