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Evaluation of the Efficacy of MaaT013 As Salvage Therapy in Acute GVHD Patients with Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-center Open-label Phase III Trial.

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Trial Profile

Evaluation of the Efficacy of MaaT013 As Salvage Therapy in Acute GVHD Patients with Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-center Open-label Phase III Trial.

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2025

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At a glance

  • Drugs Maa-T-013 (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms ARES
  • Sponsors MaaT Pharma

Most Recent Events

  • 02 Jun 2025 According to a MaaT Pharma media release, The Company also integrated supporting safety and efficacy data from 186 aGvHD patients treated under its ongoing EAP, which aligns with the positive topline results of the ARES trial and further supports Xervyteg's strong efficacy and favorable safety profile in aGvHD. Additional secondary endpoints, including overall survival, from this trial will become available in late H2 2025.
  • 02 Jun 2025 According to a MaaT Pharma media release, company announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013, under the registered brand name of Xervyteg. The MAA is supported by positive results from the Pivotal ARES study. The EMA will review the application under the centralized marketing authorization procedure and potentially a marketing authorization could be granted in H2 2026.
  • 18 Mar 2025 According to a MaaT Pharma media release, Evaluation of the One-year Overall Survival (secondary endpoint evaluation) is expected in Q4 2025.

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