MaaT Pharma Announces Positive Final Results for ARES Trial
MaaT Pharma has disclosed the final results of its phase 3 clinical trial, ARES, assessing MaaT013 for the treatment of refractory acute graft-versus-host disease.
Overview of the ARES Trial
According to MaaT Pharma, the ARES trial, a single-arm phase 3 study, evaluated the use of MaaT013 (Xervyteg) in 66 adults with severe acute graft-versus-host disease (aGvHD) featuring gastrointestinal involvement resistant to steroids and ruxolitinib. The final results showed a gastrointestinal overall response rate (GI-ORR) of 62% at 28 days, with 38% of patients achieving a complete response. This response rate was maintained at 47% at 56 days, and 44% at three months. The one-year overall survival rate reached 54%.
Significant Clinical Benefits Highlighted
Professor Florent Malard, the principal investigator of the trial, explained that both primary and secondary endpoints indicate that MaaT013 provides a durable clinical benefit for patients who have exhausted all approved treatment options. The median survival has not been reached, suggesting that a majority of patients were still alive at the end of the study. Patients who showed a gastrointestinal response at 28 days had a significantly higher survival rate, at 68%, compared to those who did not respond, according to the release.
Regulatory and Future Prospects
MaaT013 is currently under evaluation by the European Medicines Agency (EMA) for marketing authorization, with a decision expected by mid-2026. The results of the ARES study will be submitted for publication in a recognized medical journal. MaaT013 could become the first oncology microbiome therapy approved as a third-line treatment for aGvHD.
