Microbiotica unveils data on the mechanism of action of MB310, a clinical-stage drug candidate in development for the treatment of ulcerative colitis

Data presented at key congresses in North America and Europe

Cambridge, UK – 21 February 2025: Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), has presented new data on the mechanism of action of MB310, its product in development as a treatment for ulcerative colitis (UC), at the Keystone Symposia ‘Human Microbiome: Diversity, Selection and Adaptation’ held February 18-21 in Banff, Canada and at the European Crohn’s and Colitis Organisation (ECCO) meeting held February 19-22 in Berlin.

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.

Data from new preclinical studies presented at the congresses demonstrated that MB310 acts via at least three independent mechanisms of action (MOA) 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.  This included novel data demonstrating that different strains induce regulatory T-cells by different mechanisms. MB310 is in a Phase 1 study COMPOSER-1, with data readout expected by the end of 2025.

At the ECCO meeting Dr Fernanda Schreiber, Associate Director of Translational Biology, will present ‘Mechanistic understanding of MB310: a consortium of gut commensal bacteria for the treatment of ulcerative colitis’.  The poster can be accessed here (https://microbiotica.com/2025-ecco-poster).

At the Keystone meeting, Microbiotica’s Senior Vice President of Research, Dr Mat Robinson, presented a poster entitled ‘Mechanistic understanding of eight commensal gut bacteria associated with clinical remission in ulcerative colitis patients’. The poster can be accessed here (https://microbiotica.com/2025-keystone-poster).

In addition, the Company’s Chief Scientific Officer and co-founder, Dr Trevor Lawley, delivered a presentation at the Keystone meeting on ‘Integrating Mass Culturing and Metagenomic Analysis for Human Microbiome Translational Science’. In this session Trevor drew on his experience as a Senior Group Leader at the Wellcome Sanger Institute combined with his CSO role at Microbiotica.

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About Ulcerative Colitis – MB310 and the COMPOSER-1 study

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 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.

Microbiotica announced the start of its first clinical trial with MB310, in November 2024 the COMPOSER-1 study. The study is investigating 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) . Data readout is expected by the end of 2025.

About Microbiotica

Microbiotica is a private, clinical-stage, biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs) with lead programmes 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 favourable 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 programmes 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 programmes 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, please visit www.microbiotica.com, and follow us on LinkedIn.

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