Microbiotica, a clinical-stage biopharma company developing oral precision microbiome medicines, has announced the first patient dosing in its Phase 1b trial COMPOSER-1 of MB310 for ulcerative colitis (UC) patients. The international study will recruit up to 30 adult patients at clinical centers across the UK, Austria, Bulgaria, Poland and Spain, with initial data readouts expected by the end of 2025.
Novel Microbiome Approach Targets UC Pathology
MB310 represents a precision microbiome medicine delivered as an oral capsule containing a defined consortium of eight live gut commensal bacterial strains. The therapy is designed to deliver long-term remission to UC patients without immunosuppression or unwanted side effects. Ulcerative colitis affects over 1.4 million people globally and represents a significant unmet medical need in inflammatory bowel disease.
The COMPOSER-1 study is a randomized, placebo-controlled, double-blind clinical trial investigating the safety, tolerability, and initial signals of efficacy of MB310. Patients with active, mild-to-moderate UC will take two capsules of study medication once daily for 12 weeks in addition to their standard of care medication, followed by a 12-week follow-up period. The trial will also measure the degree to which the bacteria within MB310 successfully engraft into patients' intestinal microbial community.
Data-Driven Development from FMT Studies
The bacterial strains in MB310 were identified through analysis of clinical and microbiome data from a faecal microbiota transplant (FMT) study in UC patients conducted with collaborators at the University of Adelaide. The FMT study demonstrated the ability of microbiome therapy to induce remission in UC without significant side effects. Microbiotica's analysis identified the specific engrafting bacteria 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 central to UC pathology: promoting healing of the damaged gut epithelial barrier, regulating the balance of inflammatory cytokines (TNF) and immune-modulatory cytokines (IL-10), and inducing a regulatory T-cell response.
Expert Perspectives on Microbiome-Based Treatment
Professor Walter Reinisch, Professor for Gastroenterology and Hepatology at Vienna Medical University and a principal investigator in the study, emphasized the significance of the approach: "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, highlighted the scientific foundation: "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."
Company Pipeline and Partnerships
Microbiotica, spun out of the Wellcome Sanger Institute in 2016, is developing a pipeline of oral precision microbiome medicines with lead programs in immuno-oncology and inflammatory bowel disease. The company has raised more than £62 million in equity investment, including a £50 million Series B in 2022. Beyond MB310, the company is also developing MB097 for advanced melanoma and has partnerships with Cancer Research UK, Cambridge University Hospitals, and a clinical trial supply agreement with MSD for use of KEYTRUDA in melanoma patients with primary resistance to anti-PD-1 immunotherapy.
