MB310, a live biotherapeutic developed by Cambridge-based Microbiotica, achieves 63% remission rate in early study
IP Group PLC (LSE:IPO), the London-listed investor in science and technology companies, has announced that portfolio company Microbiotica has reported positive results from a Phase 1b trial of its lead microbiome medicine in ulcerative colitis.
The trial met its primary and secondary endpoints, with MB310 demonstrating a strong safety profile, robust engraftment of its eight-strain bacterial consortium and statistically significant clinical improvements compared with placebo.
MB310, an oral live biotherapeutic taken once daily, achieved clinical remission in 63.2% of patients receiving treatment, compared with 30% in the placebo group. All treated patients who entered follow-up maintained remission, with complete resolution of rectal bleeding.
Dr Robert Tansley, Chief Medical Officer at Microbiotica, said the results showed MB310’s potential to deliver long-term remission. “Our first-in-human study has demonstrated safety and tolerability together with encouraging efficacy data,” he said.
COMPOSER-1, a double-blind, placebo-controlled trial, enrolled 29 adults with active, mild-to-moderate disease across sites in the UK, Austria, Bulgaria, Poland and Spain. Patients received MB310 or placebo alongside standard care for 12 weeks, followed by 12 weeks of monitoring.
The study found all eight bacterial strains engrafted rapidly and remained detectable throughout treatment and follow-up, indicating full exposure to the product across the study duration.
MB310 also improved histological markers of epithelial damage and reduced levels of faecal calprotectin, a key biomarker of bowel inflammation. Withdrawal rates were similar in both treatment arms.
IP Group holds a 16.7% interest in Microbiotica, valued at £13.9 million as of last June.
Microbiotica, based at Chesterford Research Park near Cambridge, plans to advance MB310 into a Phase 2/3 trial in combination with existing anti-inflammatory or immune-modulatory therapies.
The company said it would explore partnering and financing options to support the programme’s next stage.