Breakthrough in ulcerative colitis treatment? Microbiotica unveils MB310 data

Microbiotica, a clinical-stage biopharmaceutical company pioneering microbiome-based therapy, has presented significant new data on MB310, its investigational treatment for ulcerative colitis, at two prominent medical conferences. The findings were disclosed at the Keystone Symposia ‘Human Microbiome: Diversity, Selection and Adaptation’ in Banff, Canada, and the European Crohn’s and Colitis Organisation (ECCO) conference in Berlin.

The newly presented clinical trial data offers a deeper understanding of MB310’s mechanism of action, underscoring its potential to deliver long-term remission without immunosuppression. The insights position MB310 as a promising alternative to conventional ulcerative colitis treatment, aiming to restore gut microbiome balance through live biotherapeutic products (LBPs) rather than traditional immunosuppressive drugs.

What Makes MB310 a Potential Breakthrough in Ulcerative Colitis Treatment?

MB310 is an orally administered microbiome-based therapy designed to address ulcerative colitis, a chronic inflammatory bowel disease affecting millions globally. Unlike existing treatments that primarily focus on suppressing the immune system, MB310 takes a novel approach by leveraging the gut microbiome to restore intestinal health.

Developed in collaboration with the University of Adelaide, MB310 consists of a precisely formulated consortium of eight live gut commensal bacterial strains. These strains were identified through an extensive clinical and microbiome analysis of a faecal microbiota transplant (FMT) study conducted in ulcerative colitis patients. The research demonstrated the ability of specific bacterial strains to induce clinical remission, leading to the formulation of MB310 as a targeted microbiome-based therapy.

How Does MB310 Work to Restore Gut Health?

Microbiotica’s latest clinical trial data reveals that MB310 exerts its therapeutic effects through three independent mechanisms that are crucial to controlling ulcerative colitis:

The first mechanism involves repairing the gut epithelial barrier, which is essential in preventing chronic inflammation. The bacterial strains within MB310 contribute to strengthening the intestinal lining, reducing permeability and inflammation.

The second mechanism focuses on modulating inflammatory cytokines, particularly by balancing tumor necrosis factor (TNF), a pro-inflammatory cytokine, with interleukin-10 (IL-10), an immune-modulating molecule. This cytokine regulation is critical for maintaining immune homeostasis and preventing excessive inflammatory responses.

The third mechanism highlights MB310’s ability to induce regulatory T-cell responses, an essential function in immune tolerance. Notably, Microbiotica’s research demonstrated that different bacterial strains within MB310 induce regulatory T-cells through distinct pathways, offering a multi-faceted approach to immune modulation.

What Did Microbiotica Present at the ECCO and Keystone Meetings?

At the ECCO conference, Dr. Fernanda Schreiber, Associate Director of Translational Biology at Microbiotica, detailed MB310’s mechanistic understanding in a presentation titled “Mechanistic understanding of MB310: a consortium of gut commensal bacteria for the treatment of ulcerative colitis.” Her talk emphasized how MB310’s bacterial strains interact with the gut microbiome to induce sustained remission.

Simultaneously, at the Keystone Symposia, Dr. Mat Robinson, Senior Vice President of Research, presented new clinical trial data in a poster titled “Mechanistic understanding of eight commensal gut bacteria associated with clinical remission in ulcerative colitis patients.” The presentation provided insights into how MB310’s individual bacterial strains work together to create a balanced and stable gut microbiota composition.

Additionally, Dr. Trevor Lawley, Chief Scientific Officer and co-founder of Microbiotica, spoke on “Integrating Mass Culturing and Metagenomic Analysis for Human Microbiome Translational Science.” Drawing on his expertise as a Senior Group Leader at the Wellcome Sanger Institute, Dr. Lawley discussed the proprietary microbiome profiling platform that enabled the precise identification of bacterial strains linked to clinical remission.

What Is the COMPOSER-1 Study and What Does It Aim to Achieve?

Microbiotica initiated its first clinical trial with MB310 in November 2024 under the COMPOSER-1 study. This randomised, placebo-controlled, double-blind Phase 1 clinical trial is evaluating MB310’s safety, tolerability, and initial efficacy signals in patients with mild-to-moderate ulcerative colitis. The study is designed to investigate whether MB310 can successfully engraft within patients’ intestinal microbiota and sustain long-term remission.

Participants in the trial receive two capsules of MB310 or a placebo daily for 12 weeks, alongside their standard ulcerative colitis treatment. The study also includes a 12-week follow-up period, where researchers will assess the extent to which MB310’s bacterial strains integrate into the patient’s gut microbiome. The trial is registered under NCT06582264 and 2023-507376-50, with a clinical trial data readout expected by the end of 2025.

How Does MB310 Fit into Microbiotica’s Broader Biopharma Strategy?

Microbiotica, headquartered at Chesterford Research Park near Cambridge, UK, is recognized for its pioneering work in microbiome-based therapy. Since its spin-out from the Wellcome Sanger Institute in 2016, the company has secured over £62 million in equity investment, including a £50 million Series B round in 2022. Investors include British Patient Capital, Cambridge Innovation Capital, Flerie Invest, IP Group plc, Seventure Partners, and Tencent.

Beyond ulcerative colitis treatment, Microbiotica is advancing MB097, a microbiome therapy for advanced melanoma. The company has a clinical trial supply agreement with Merck & Co., Inc. (MSD) to use KEYTRUDA in evaluating MB097’s efficacy in melanoma patients resistant to anti-PD-1 immunotherapy. Additionally, Microbiotica has established a major partnership with Cancer Research UK and Cambridge University Hospitals to further investigate the role of microbiome-based therapy in oncology.

What’s Next for MB310 and the Future of Microbiome-Based Therapy?

As Microbiotica progresses toward the COMPOSER-1 study’s data readout in late 2025, the company remains optimistic about MB310’s potential to redefine ulcerative colitis treatment. If the trial confirms MB310’s ability to deliver long-term remission without immunosuppression, it could mark a significant advancement in inflammatory bowel disease management.

With increasing recognition of the gut microbiome’s role in immune regulation, microbiome-based therapies are gaining traction as viable alternatives to traditional treatments. As research continues, Microbiotica’s approach to clinical trial data-driven microbiome drug discovery could pave the way for a new era in ulcerative colitis treatment and beyond.