Microbiotica has completed patient recruitment in its international Phase Ib MELODY-I clinical trial of MB097, a precision microbiome co-therapy for advanced melanoma.
This randomised, open-label trial enrolled 41 patients at centres in France, Italy, Spain, and the UK. Initial study findings are anticipated in the first half of 2026.
The focus of the MELODY-I trial, a first-in-human study, is to evaluate the tolerability, safety and initial efficacy signals of MB097 along with MSD’s Keytruda (pembrolizumab) in patients whose melanoma is resistant to anti-PD-1 therapy.
All participants in the study will receive MB097 and pembrolizumab for a period of up to six months.
Half of the enrolled subjects will also receive vancomycin before beginning the co-therapy, allowing study leaders to assess whether vancomycin enhances engraftment and growth of MB097’s bacterial strains in the gut.
Patients receiving clinical benefit after the initial six-month period may continue receiving pembrolizumab for up to 18 months, for a total possible duration of 24 months.
MB097 is an orally administered, once-daily live biotherapeutic product comprising nine commensal bacteria strains designed to improve the efficacy of immune checkpoint inhibitors (ICIs).
Microbiotica chief medical officer Dr Robert Tansley said: “In cancer patients, the bacteria in MB097 appear to be associated with better response rates to immune checkpoint inhibitor therapies such as anti-PD-1 drugs.
“MB097, with its precisely selected microbes based on data from responsive patients, in combination with ICIs, could therefore activate a therapeutic benefit for non-responding patients with advanced melanoma.
“Moreover, as the MB097 bacteria are found in healthy subjects, as well as in patients who responded to ICIs, we anticipate a favourable safety profile. We thank the investigators and patients for participating in the study and look forward to the results.”
Microbiotica dosed the first subject in the Phase Ib MELODY-1 clinical trial in October 2024.
