The Cambridge-based company Microbiotica announced today that it has received approvals to initiate clinical trials in some EU countries and the UK for two of its live biotherapeutic products (LBPs), which are oral precision microbiome medicines. The trials are expected to begin soon, with first results expected by the end of 2025.
One study, named MELODY-1, will focus on the safety and first signals of efficacy of MB097, an LBP that consists of nine bacterial strains, designed to boost the efficacy of immune checkpoint inhibitors, a type of immunotherapy. MELODY-1 will focus on patients with advanced melanoma, who haven’t initially responded to immunotherapy. MB097 will be administered orally in combination with MSD’s checkpoint inhibitor Keytruda (pembrolizumab).
In preclinical studies, the bacterial consortium in MB097 has been found to enhance essential pathways of the immune system, aiding in the activation of cytotoxic T cells and natural killer cells, enabling them, in turn, to identify and kill tumor cells.
“The treatment of patients with advanced melanoma has been revolutionized by immune checkpoint inhibitors,” explained Claire Birrell, Microbiotica’s VP of Clinical Development in a press release.
“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 immune checkpoint inhibitors, has the potential to enhance the therapeutic benefit for patients with advanced melanoma.”
Microbiotica’s second study, COMPOSER-1, will evaluate the safety and initial signs of efficacy of MB310 for the treatment of ulcerative colitis, the most common form of inflammatory bowel disease, which affects around 5 million people worldwide. MB310 is designed to be taken as an oral capsule once a day and aims for long-term remission in ulcerative colitis patients. If the medicine is successful, patients would no longer need immunosuppressants and could avoid unwanted side effects.
Gained from healthy donors, MB310 is a microbial consortium of eight bacterial strains that have been shown to act on pathological mechanisms in ulcerative colitis. In preclinical studies, MB310 demonstrated the regulation of inflammatory and immune-modulating cytokines, promoted healing of the gut epithelial barrier, which gets damaged in ulcerative colitis, and induced a regulatory T cell response.
“Starting our first clinical trials is a major milestone for the Company,” said Tim Sharpington, CEO of Microbiotica. “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.”