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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