MaaT to move microbiome drug into Phase III trial

French microbiome company MaaT Pharma has announced top-line results from a Phase II trial evaluating MaaT013 in a high-risk patient population with grade III-IV steroid-refractory, gastrointestinal-predominant acute graft-versus-host disease (SR-GI-aGvHD).

The study met its primary endpoint of clinical efficacy, demonstrating a combined 33.3% complete response rate or very good partial response rate at day 28. In addition, the overall response rate was 38.1% at day 28 and the best overall response rate was 57.1%. MaaT013 also showed an acceptable safety profile.

"Validates our approach of restoring the microbial ecosystem to normalize the immune response"Based on the beneficial clinical outcomes and good safety profile observed to date in more than 70 patients treated as part of both the HERACLES trial and an early access program, MaaT plans to initiate a pivotal Phase III trial in GI-aGvHD with MaaT013.