Microbiotica's MB310 Achieves 63% Clinical Remission Rate in Phase 1b Ulcerative Colitis Trial
核心洞察
Microbiotica (搜索)'s precision microbiome medicine MB310 demonstrated clinical remission in 63% of ulcerative colitis (搜索) patients compared to 30% with placebo in the COMPOSER-1 Phase 1b trial.
All patients completing MB310 treatment maintained sustained clinical remission with complete resolution of rectal bleeding during the 3-month follow-up period.
The oral once-daily treatment showed successful engraftment of all eight bacterial strains and was well tolerated with a safety profile indistinguishable from placebo.
Microbiotica (搜索) Ltd has announced positive results from its Phase 1b first-in-human trial COMPOSER-1, demonstrating that its precision microbiome medicine MB310 achieved clinical remission in 63.2% of ulcerative colitis (搜索) patients compared to 30% in the placebo group. The Cambridge-based clinical-stage biopharma company's oral treatment represents a potential breakthrough in addressing the underlying pathophysiology of ulcerative colitis through microbiome restoration.
Trial Design and Patient Population
The COMPOSER-1 study was a randomized, placebo-controlled, double-blind clinical trial that recruited 29 adult patients across five European countries including the UK, Austria, Bulgaria, Poland, and Spain. Patients with active, mild-to-moderate ulcerative colitis (搜索) took 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.
Efficacy Results Demonstrate Disease Modification Potential
The study met its primary and secondary objectives, with MB310 showing statistically significant improvements in efficacy parameters compared with placebo. Clinical remission was achieved in 12 out of 19 MB310-treated patients (63.2%) versus 3 out of 10 placebo-treated patients (30%) using the partial Mayo score, the standard disease activity index.
Notably, all 12 patients who completed MB310 treatment and entered the follow-up stage maintained sustained clinical remission at the end of study. Complete resolution of rectal bleeding, a symptom of particular importance in ulcerative colitis (搜索), was observed in all patients who entered follow-up.
The treatment also demonstrated improvement in objective histological measures of disease activity, with striking improvements in microscopic markers of mucosal damage and gut epithelial barrier integrity. Additionally, MB310 treatment reduced faecal calprotectin, a key biomarker of active bowel inflammation.
Successful Bacterial Engraftment and Safety Profile
MB310 achieved rapid and robust engraftment of all eight bacterial strains in the consortium, which was fully maintained throughout the 3-month dosing period and 3-month follow-up. This indicates patients had full exposure to MB310 for the entire study duration.
The treatment was well tolerated with a safety profile indistinguishable from placebo and withdrawal rates similar in both arms. Dr. Robert Tansley, Microbiotica (搜索)'s Chief Medical Officer, noted that "the highly encouraging clinical remission rates at 6 months, is more impressive than any ulcerative colitis (搜索) therapy I have seen to date."
Mechanism of Action and Clinical Significance
Preclinical studies have demonstrated that the MB310 consortium acts via at least three independent mechanisms central to ulcerative colitis (搜索) pathology: promoting healing of the damaged gut epithelial barrier, regulating the balance of inflammatory cytokines (TNF (搜索)) and immune-modulatory cytokines (IL-10), and inducing a regulatory T-cell response.
Professor Herbert Tilg from Medical University, Innsbruck, Austria and Scientific Advisory Board member, commented: "By dosing with healthy bacterial species shown to be associated with clinical improvements in ulcerative colitis (搜索), MB310 has the potential to be a transformative medicine that could be disease modifying and change the underlying natural pathology of the condition."
Market Context and Future Development
Ulcerative colitis (搜索) affects over 1.4 million people globally and represents a significant unmet medical need. The gut microbiome is now understood to contribute significantly to disease pathology but is not targeted by current therapies.
CEO Tim Sharpington stated: "MB310 has the potential to be a new, differentiated treatment modality for patients with ulcerative colitis (搜索), offering the hope of long-lasting disease remission without side effects." The company plans to explore partnering and financing options during 2026 to fund products through later studies toward commercialization.
Next Steps in Clinical Development
Microbiotica (搜索) is conducting additional analysis of COMPOSER-1 data to inform the design of an adaptive Phase 2/3 study. The anticipated study will explore MB310's disease-modifying potential in combination with anti-inflammatory and/or immunomodulatory induction agents, leveraging what the company describes as a "slower-onset longer-acting" therapeutic approach.
The company's clinic-led microbiome discovery platform enables precision identification of bacterial strains associated with favorable clinical outcomes, providing validation for their approach to developing precision microbiome medicines across different disease settings.