Microbiotica unveils multiple mechanisms by which MB310, in clinical development for the treatment of ulcerative colitis, protects the intestinal barrier

Data presented at Digestive Disease Week in San Diego

/EIN News/ -- CAMBRIDGE, United Kingdom, May 06, 2025 (GLOBE NEWSWIRE) -- 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 Digestive Disease Week (DDW) 3rd – 6th May in San Diego.

The gut epithelial barrier is compromised in UC patients leading to an exaggerated inflammatory response. MB310 is an LBP comprising eight bacterial species associated with clinical benefit in UC when engrafted in the gut microbiome of patients following faecal microbiota transplant. Data from new preclinical studies presented at DDW demonstrated that three bacterial strains in MB310 enhance the epithelial barrier integrity by three distinct mechanisms: release of nicotinic acid; polyamine production; and expression of a novel protein IZOR (Internalin-like ZO1 Regulator). This is in addition to the previously reported data that demonstrates that the MB310 strains also modulate inflammatory and adaptive immune mechanisms central to UC pathology.

Tim Sharpington, CEO of Microbiotica, presented these novel findings in a poster entitled “Gut commensal bacteria, associated with clinical remission in ulcerative colitis, protect and heal gut epithelial barrier through three novel pathways.”  The poster can be accessed here.

Mat Robinson, Microbiotica’s SVP Research, said, “These data begin to identify the different mechanisms by which an individual’s intestinal microbiome helps to maintain a healthy gut barrier. This is disrupted in UC patients, and we now know how MB310 can reverse this. We have previously shown that MB310 also modulates the other two key pathological drivers of UC, namely the inflammatory response and the adaptive immune system. MB310 uniquely has the potential to impact all the key drivers in UC through multiple mechanisms.”

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. MB310 is in a Phase 1 study COMPOSER-1, with data readout expected by the end of 2025.

Notes to Editors

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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