MaaT Pharma: 62% Response Rate for Its Drug Candidate, EMA Decision by Mid-2026
MaaT Pharma announced on Monday the presentation of the final results of the pivotal ARES trial evaluating MaaT013 in acute gastrointestinal graft-versus-host disease. The drug candidate, currently under review by the European Medicines Agency, could receive a regulatory decision by mid-2026.
Results of the ARES Trial
The ARES trial, an open-label, single-arm study, evaluated MaaT013 as a third-line treatment in 66 adult patients with severe steroid-refractory and ruxolitinib-refractory gastrointestinal aGvH, across 50 centers in six European countries. The final results showed a gastrointestinal response rate (GI-ORR) of 62% at day 28, maintained at 47% at day 56 and 44% at three months, with an overall survival rate at twelve months of 54%. An early gastrointestinal response correlated with improved survival, with one-year survival at 68% among responders at day 28 compared to 28% among non-responders. An independent monitoring committee reported in March 2025 an acceptable safety profile and a favorable benefit-risk ratio.
Regulatory Review and Conference Presentation
MaaT013 was submitted for review to the European Medicines Agency in June 2025, with a decision expected by mid-2026. The final results of the ARES trial were presented during the presidential plenary session of the 2026 annual congress of the European Society for Blood and Marrow Transplantation in Madrid. MaaT Pharma also presented three posters at this congress: the PHOEBUS trial evaluating MaaT033 for intestinal microbiota optimization, the CHRONOS study describing real-world outcomes in third-line gastrointestinal aGvH, and the THRASSA trial assessing MaaT013 in pediatric and adolescent patients. The results have been submitted for publication in a peer-reviewed medical journal and will be presented at the annual congress of the French Society of Hematology on March 27, 2026, in Paris.
