Microbiotica gets go-ahead to initiate two clinical studies

Microbiotica 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.

With both studies are due to start shortly – and initial data readouts expected by the end of 2025 – the upshot is that the biopharma company is transitioning to clinical stage.

Microbiotica was founded in 2016 by Dr Trevor Lawley, Dr Mike Romanos, and Prof Gordon Dougan at the Wellcome Sanger Institute. From its base at Chesterford Research Park, it is developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs).

The company has raised £62million in equity investment to date, including a £50million Series B in 2022, with venture investors including British Patient Capital, Cambridge Innovation Capital, Flerie Invest, IP Group plc, Seventure Partners and Tencent.

Of the two studies, MELODY-1 will evaluate safety and initial signals of efficacy of MB097, a once-daily, orally administered LBP to treat advanced melanoma, in combination with the immune checkpoint inhibitor (ICI) KEYTRUDA (provided by Merck).

MB097 consists of a defined consortium of nine bacterial strains designed to enhance the efficacy of ICIs. The bacterial strains in MB097 were identified by analysing 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.

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 (UC), the 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.

Claire Birrell, Microbiotica’s VP clinical development, said: “The treatment of patients with advanced melanoma has been revolutionised by ICIs. By optimising 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.”

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.”