Microbiotica Secures Approvals to Begin Clinical Studies in EU and UK for New Microbiome Medicines

Microbiotica, a biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), is pleased to announce that it has received regulatory approvals to initiate clinical studies for its first two programmes in advanced melanoma (MELODY-1) and ulcerative colitis (COMPOSER-1) in selected EU countries and the UK. Both studies are due to start shortly, with initial data readouts expected by the end of 2025.

As it transitions to a clinic-stage company, Microbiotica is also pleased to have secured additional funding from existing investors, giving the Company the financial runway to complete these clinical trials.

MELODY-1 study – MB097 – Advanced melanoma

The MELODY-1 study will evaluate safety and initial signals of efficacy of MB097 in advanced melanoma, in combination with KEYTRUDA^® (pembrolizumab), MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy. MSD will supply KEYTRUDA (study identifiers NCT06540391; MSD KEYNOTE-E75; 023-507377-17).

MB097 is a once daily, orally administered LBP consisting of a defined consortium of nine bacterial strains designed to enhance the efficacy of ICIs. The bacterial strains in MB097 were identified by analyzing the microbiome of patients in multiple studies of ICIs in melanoma, including the MELRESIST study carried out with the company’s collaborators at Cambridge University Hospitals. Collectively, the MB097 bacterial consortium provides microbiome signaling needed for ICI response.  Preclinical studies demonstrate that MB097 stimulates core pathways of the immune system to activate Cytotoxic T Lymphocytes, and Natural Killer cells to enable them to kill tumour cells.

COMPOSER-1 study – MB310 – Ulcerative colitis

The COMPOSER-1 study will investigate the safety and initial signals of efficacy of a once-daily oral dose of MB310 for the treatment of ulcerative colitis, an inflammatory bowel disease. MB310 is a defined microbial consortium identified from healthy donors, which induced disease remission in patients with UC who participated in a clinical trial at the University of Adelaide.  

Preclinical studies have demonstrated that MB310 acts via at least three independent mechanisms that are central to UC pathology: promoting the healing of the damaged gut epithelial barrier; regulating the balance of inflammatory and immune-modulatory cytokines; and inducing a regulatory T-cell response. (Study identifiers 2023-507376-50 (EudraCT)).

The treatment of patients with advanced melanoma has been revolutionized by ICIs. By optimizing the patient’s gut microbiome there is an opportunity to increase the number of patients who can benefit from these treatments. We believe that MB097, in combination with ICIs, has the potential to enhance the therapeutic benefit for patients with advanced melanoma. Similarly, with MB310, we see great potential in treating ulcerative colitis, where there remains significant unmet medical need.”

Claire Birrell, Microbiotica’s VP Clinical Development

Tim Sharpington, Microbiotica’s CEO, said, “Starting our first clinical trials is a major milestone for the Company. We are delighted to have been given two regulatory approvals in quick succession and to have completed the manufacture of our clinical trial supplies batches. Working closely with our collaborators and clinical sites, we will initiate both trials in the coming weeks and look forward to treating patients with these promising new medicines.”