Microbiotica has completed patient recruitment for its phase 1b trial, COMPOSER-1, evaluating MB310 in adults with ulcerative colitis.
The study has enrolled 29 patients across sites in the UK, Austria, Bulgaria, Poland and Spain. Initial results are expected by the end of 2025.
COMPOSER-1 is a randomised, placebo-controlled, double-blind trial assessing safety, tolerability and early efficacy signals of MB310. The study also measures how well MB310’s bacterial strains engraft into the patients’ gut microbiome.
Participants with active, mild-to-moderate ulcerative colitis are receiving two capsules daily for 12 weeks, alongside standard care. This is followed by a 12-week observation period.
MB310 is an oral live biotherapeutic product containing eight gut commensal bacterial strains. It is designed to induce long-term remission without immunosuppression or significant side-effects.
The strains were identified through analysis of clinical and microbiome data from a faecal microbiota transplant study in ulcerative colitis patients, conducted with the University of Adelaide. Engrafting bacteria linked to clinical response informed MB310’s development.
Preclinical studies show MB310 acts via three mechanisms: repairing the gut epithelial barrier, modulating inflammatory and immune cytokines, and inducing regulatory T-cell responses.
Ulcerative colitis affects over 1.4 million people globally. Microbiotica aims to offer a targeted microbiome-based therapy for this chronic condition.
Dr Robert Tansley, Chief Medical Officer at Microbiotica, said: “We are delighted that enrolment into the trial has proceeded to plan and that the trial is now fully recruited. We thank our investigational sites and the patients for their participation, and eagerly await the results of the study.”
He added: “There is a considerable body of evidence that FMT is beneficial for mild-to-moderate UC patients, and we believe our microbiome approach based on specific bacteria could provide a precision microbiome-based treatment for this debilitating disease.”
