The study met its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrates the unprecedented efficacy of MaaT013 as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD).
- High gastrointestinal overall response rate (GI-ORR) exceeding the expected response rate of 38%. Complete response (CR), only, was 38% and very good partial response (VGPR) was 20%.
- Frequent and strong all-organ responses (ORR), prevalently consisting of complete response (CR) of 36% and very good partial response (VGPR) of 18%, reflecting systemic effects beyond the gastrointestinal tract.
54% probability of survival at 1 year driven by clinical response, highlighting MaaT013’s potential to overcome the short-term mortality of third-line GI-aGvHD.
- Company anticipates MAA submission in Europe in mid-2025, earlier than initially planned.
Conference call and webcast to be held on Thursday, January 9, 2025, at 4.00PM CET/ 7.00 AM PST/ 10.00AM EST/ 7.00PM GST
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