MaaT Pharma Clinical Trial Recruitment Concluded

MaaT Pharma announced the completion of enrollment in its Phase 3 ARES clinical trial for the treatment of acute graft-versus-host disease (aGvHD) with its drug candidate MaaT013. The trial, which aims to evaluate the efficacy of the treatment in patients refractory to steroids and ruxolitinib, met its enrollment targets with 66 evaluable patients.

The independent Safety Monitoring Board (DSMB) issued a positive opinion on the trial in the fourth quarter of 2023, highlighting a favorable benefit/risk ratio with high efficacy and low toxicity. Top-line results from the study are expected in January 2025, followed by a planned submission for registration in Europe the same year.

MaaT013 is already available under a compassionate access program in six European countries, where more than 180 patients have been safely treated. This advancement reinforces MaaT Pharma in its mission to deliver a novel, effective microbiota-related oncology therapy.