Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) on Monday unveiled promising data for MaaT013 in acute graft-versus-host disease (aGvHD).

Data from 140 patients with steroid-refractory (SR) or steroid-dependent (SD) gastrointestinal acute graft-versus-host disease (GI-aGvHD) treated with MaaT013 shows a 52% gastrointestinal overall response rate (GI-ORR) at Day 28 and a notable 42% overall survival (OS) at 18 months for all patients, with 58% OS in responder patients.

In the third-line setting, MaaT013 exhibited a 63% GI-ORR at Day 28 and 53% at Day 56, the highest reported overall survival in this patient population.

Hervé Affagard, CEO and co-founder of MaaT Pharma, highlighted the significance of these findings, demonstrating the potential for MaaT013 to address unmet needs in the treatment landscape for GI-aGvHD patients.

A pivotal Phase 3 trial (ARES trial) is currently ongoing to evaluate MaaT013 in corticosteroid and ruxolitinib-refractory GI-aGvHD, with results expected in mid-Q4 2024.

MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), underscoring its importance in advancing therapeutic options for this rare disease.