Microbiotica set to hit high notes via COMPOSER-1

The company reveals that patient recruitment is complete in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients.

This international trial has recruited 29 adult patients at clinical centres in the UK, Austria, Bulgaria, Poland and Spain. Initial results are expected by the end of 2025.

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

The degree to which the bacteria within MB310 successfully engraft into patients’ intestinal microbial community is also being measured. The study has recruited patients with active, mild-to-moderate UC, who are taking two capsules of MB310 (active or matched placebo) once a day for 12 weeks in addition to their standard of care medication, with a 12-week follow-up period.

Ulcerative colitis, an inflammatory bowel condition, is a debilitating disease that affects over 1.4 million people globally. MB310 has been developed as an oral capsule, dosed once daily, containing a defined consortium of eight live gut commensal bacterial strains with the potential to deliver long-term remission to UC patients, without immunosuppression or unwanted side-effects.

The bacterial strains in MB310 were identified by analysing clinical and microbiome data from a faecal microbiota transplant (FMT) study in UC patients, carried out with collaborators at the University of Adelaide. The results demonstrated the ability of a microbiome therapy to induce remission in UC without significant side-effects. Microbiotica‘s analysis identified the engrafting bacteria were associated with clinical response, leading to the development of MB310 as an LBP.

Preclinical studies have demonstrated that MB310 acts via at least three independent mechanisms that are central to the pathology of UC: promoting the healing of the damaged gut epithelial barrier, regulating the balance of cytokines that are inflammatory (TNF) and immune-modulatory (IL-10); and inducing a regulatory T-cell response.

Dr Robert Tansley, Microbiotica’s Chief Medical Officer, 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.

“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.”