Microbiotica has completed patient recruitment for its Phase 1b first-in-human trial COMPOSER-1, evaluating MB310 in adults with ulcerative colitis. The international study enrolled 29 patients across clinical centers in the UK, Austria, Bulgaria, Poland and Spain, with initial results expected by the end of 2025.
Trial Design and Patient Population
COMPOSER-1 is a randomized, placebo-controlled, double-blind clinical trial designed to investigate the safety, tolerability, and initial signals of efficacy of MB310. The study has recruited patients with active, mild-to-moderate ulcerative colitis who are taking two capsules of MB310 or matched placebo once daily for 12 weeks in addition to their standard of care medication, followed by a 12-week follow-up period.
The trial also measures the degree to which the bacteria within MB310 successfully engraft into patients' intestinal microbial community, a key factor in determining the therapeutic's effectiveness.
MB310 Development and Mechanism
MB310 is an oral live biotherapeutic product containing a defined consortium of eight live gut commensal bacterial strains. The therapy has been developed to deliver long-term remission to ulcerative colitis patients without immunosuppression or unwanted side-effects.
The bacterial strains in MB310 were identified through analysis of clinical and microbiome data from a faecal microbiota transplant study in ulcerative colitis patients, conducted in collaboration with the University of Adelaide. The results demonstrated the ability of a microbiome therapy to induce remission in ulcerative colitis without significant side-effects. Microbiotica's analysis identified that the engrafting bacteria were associated with clinical response, leading to the development of MB310 as a live biotherapeutic product.
Preclinical studies have demonstrated that MB310 acts via at least three independent mechanisms that are central to the pathology of ulcerative colitis: 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.
Clinical Context and Unmet Need
Ulcerative colitis is a debilitating inflammatory bowel condition that affects over 1.4 million people globally. The disease represents a significant unmet medical need for treatments that can provide sustained remission without the immunosuppressive effects associated with current therapies.
Dr. Robert Tansley, Microbiotica's Chief Medical Officer, commented on the trial completion: "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."
