Microbiotica Announces First Patient Dosed in its Phase 1b Trial of a Precision Microbiome Medicine in Ulcerative Colitis Patients

Microbiotica recently announced 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, added “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.”

Microbiotica is a private, clinical-stage, biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs) with lead programs in immuno-oncology and inflammatory bowel disease. The company has a clinic-led, purpose-built, proprietary, microbiome profiling platform to support drug discovery based on clinical data, which enables precision identification of bacteria associated with favorable clinical trial outcomes in specific patient populations. The company has significant expertise in microbiology, bioinformatics, translational biology and LBP manufacturing and development.

The company is creating a novel pipeline of programs in immuno-oncology (MB097 for advanced melanoma), and inflammatory bowel disease (MB310 for ulcerative colitis). It has a major partnership with Cancer Research UK and Cambridge University Hospitals in immuno-oncology. The company has a clinical trial supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) for use of KEYTRUDA in evaluating MB097 in melanoma patients with primary resistance to anti-PD-1 immunotherapy. MB310 was developed in collaboration with the University of Adelaide. Both programs have data read-outs in 2025.

Spun out of the Wellcome Sanger Institute in 2016, the company is based in purpose-built facilities at the Chesterford Research Park near Cambridge, UK. Microbiotica has raised more than £62 million equity investment, including a £50 million Series B in 2022, with venture investors including British Patient Capital, Cambridge Innovation Capital, Flerie Invest, IP Group plc, Seventure Partners and Tencent. The company has also received financial support from the US-based Crohn’s and Colitis Foundation. For more information, visit www.microbiotica.com.