Microbiotica announces first patient dosed in its Phase 1b Trial (COMPOSER-1) of MB310

Cambridge, UK – 13 November 2024: Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), announces that the first patient has been dosed in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients. This international trial is due to recruit up to 30 adult patients at clinical centres in the UK, Austria, Bulgaria, Poland and Spain. Initial data readouts are expected by the end of 2025.

Ulcerative colitis, an inflammatory bowel disease, 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. It is designed to deliver long-term remission to UC patients, without immunosuppression or unwanted side effects.

The COMPOSER-1 study will 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 will be measured. The study will recruit patients with active, mild-to-moderate UC, who will take two capsules of study medication (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. (Study identifiers: NCT06582264; 2023-507376-50).

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 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.

Professor Walter Reinisch, Professor for Gastroenterology and Hepatology at the Vienna Medical University, Austria, an advisor to Microbiotica and 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, said:

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. 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.