Microbiotica initiates subject dosing in Phase Ib melanoma therapy trial
Source: Clinical Trials Arena, October 2024
Microbiotica has dosed the first subject in the Phase Ib MELODY-1 clinical trial of MB097, a precision microbiome co-therapy targeting advanced melanoma.
A once-daily oral live biotherapeutic product (LBP), MB097 is composed of nine specific strains of commensal bacteria, designed to boost immune checkpoint inhibitors’ (ICIs) efficacy.
The randomised, open-label, first-in-human, global study aims to enrol up to 40 subjects at up to 18 clinical sites in the UK, Italy, France and Spain. It will assess the safety, tolerability and initial efficacy of MB097 plus MSD’s (Merck & Co.) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with cutaneous melanoma who have not responded to prior immunotherapies.