MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease
Shots:
- The P-III (ARES) trial assesses MaaT013 as a 3L treatment of acute GI-aGvHD in patients (n=66) refractory to steroids & ruxolitinib across the EU
- Trial achieved its 1EP, depicting 62% GI-ORR at D28 (38% CR & 20% VGPR); 64% ORR in all evaluable organs (36% CR & 18% VGPR); 54% survival at 12mos. (median not reached), higher in D28 responders vs non-responders (67% vs 28%). Additional EPs are being evaluated, with data to be highlighted at future conferences
- Regulatory filing of MaaT013 in this indication to the EMA is planned by mid-2025 plus will be available under EAP in the EU until commercialization by YE’26. EAP has expanded to the US as MaaT Pharma prepares for P-III, expected in 2025, pending financing
Ref: MaaT Pharma | Image: MaaT Pharma
Related News:- MaaT Pharma Receives Positive Opinion from DSMB for MaaT013 in P-III Trial to Treat Graft Versus Host Disease (GvHD)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
