Microbiotica's Microbiome Medicines Progress to Clinical Trials for Melanoma and Ulcerative Colitis
Microbiotica, a UK-based biopharma company specializing in precision microbiome medicines, has received regulatory approvals to start Phase 1b clinical trials for its leading programs targeting advanced melanoma and ulcerative colitis. These trials are set to begin soon across selected European countries and the UK.
MELODY-1: Boosting Immunotherapy in Melanoma
The MELODY-1 study will explore the safety and early efficacy signals of MB097, Microbiotica’s leading live biotherapeutic product (LBP) for treating advanced melanoma. MB097, taken orally once a day, is a carefully designed mix of nine bacterial strains aimed at enhancing the effectiveness of immune checkpoint inhibitors (ICIs) like Keytruda. These strains were identified through extensive analysis of microbiome data from melanoma patients involved in various ICI studies, including a collaboration with Cambridge University Hospitals.
Preclinical research suggests that MB097 activates key immune system pathways, encouraging Cytotoxic T Lymphocytes and Natural Killer cells to more effectively target and kill tumor cells. The study, led by Microbiotica and supported by Merck & Co., Inc., which provides Keytruda, is expected to produce initial results by the end of 2025.
COMPOSER-1: Addressing Ulcerative Colitis with Microbiome Therapy
At the same time, Microbiotica will begin the COMPOSER-1 study to assess the safety and early efficacy of MB310, an oral LBP designed to treat ulcerative colitis (UC), a chronic inflammatory bowel disease. MB310 is based on a microbial consortium identified from healthy donors, which showed promise in helping UC patients achieve remission during earlier trials at the University of Adelaide.
Preclinical studies have shown that MB310 works through several key mechanisms relevant to UC: it helps repair the gut’s epithelial barrier, regulates inflammatory cytokines, and encourages a regulatory T-cell response. The upcoming Phase 1b study will test these findings in a clinical setting, with results anticipated by late 2025.
Microbiotica's Approach and Funding
Founded in 2016 and located at Chesterford Research Park near Cambridge, UK, Microbiotica focuses on developing microbiome-based therapeutics using its proprietary microbiome profiling platform. This platform allows for the precise identification of bacterial strains associated with positive clinical outcomes in specific patient groups, driving the development of targeted LBPs.
The company’s progress is supported by key partnerships, including collaborations with Cancer Research UK, Cambridge University Hospitals, and the University of Adelaide. Additionally, the MELODY-1 study benefits from a supply agreement with Merck & Co., Inc., which provides Keytruda for the trial, emphasizing Microbiotica’s commitment to improving the effectiveness of existing cancer therapies through microbiome science.
Microbiotica has also secured additional funding to ensure the progression of these clinical trials through to their data readouts. This financial backing, which includes a Series B round in 2022, has enabled the company to continue its research and development efforts. To date, Microbiotica has raised £62 million in equity investment, with support from investors like British Patient Capital, Cambridge Innovation Capital, and Tencent. The company also receives funding from the US-based Crohn’s and Colitis Foundation, reflecting a strong interest in Microbiotica’s innovative approach to microbiome-based therapies.
Topics: Clinical Trials
