Microbiotica has announced positive findings from its phase 1b MELODY‑1 trial of MB097, an oral precision microbiome co‑therapy being developed for advanced melanoma.
The study met all primary and secondary objectives, with the company reporting that MB097 was safely combined with pembrolizumab and showed encouraging early signs of efficacy in a population with primary resistance to anti‑PD‑1 therapy.
The international trial enrolled 41 patients across the UK, France, Italy and Spain. Participants received MB097 alongside pembrolizumab for up to six months, with half also given vancomycin preconditioning to assess whether it improved bacterial engraftment.
Microbiotica said the nine‑strain bacterial consortium demonstrated robust engraftment, particularly in those receiving vancomycin.
Dr Pippa Corrie, National Co‑ordinating Investigator for the study, said: “There is increasing evidence that the microbiome plays a crucial role in patients’ response to immune checkpoint inhibitors. Clinical benefit has been reported with Faecal Microbiota Transplantations (FMT), while MB097 capsules taken orally each day affords an easy and reproducible way of modifying the microbiome.
She added: “The MELODY‑1 study results show that MB097 is well tolerated, with encouraging early signs of efficacy in a very difficult to treat metastatic melanoma patient population with primary resistance to anti-PD-1 based immunotherapy, in whom there is a significant unmet need.”
Patients benefiting at six months have entered an extension phase and may continue pembrolizumab for up to 18 additional months, with results to follow.
Dr Robert Tansley, Chief Medical Officer at Microbiotica, said: “We are encouraged by these positive data on safety and engraftment. With early signs of efficacy, we look forward to further analysis from the trial respondents.
“The results provide the foundation to proceed to larger controlled studies in a broader melanoma patient population and we are excited by the potential to deliver a new option to maximise patients’ potential to respond to anti-PD-1 therapy.”
CEO Tim Sharpington added: “This is our second clinical trial to report positive results, following the success of our phase 1b study of MB310 in ulcerative colitis earlier this year. This is further validation of our clinic-first discovery platform and precision microbiome medicine development.”
