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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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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: 28 Mar 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

    • 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.
    • 18 Mar 2025 According to a MaaT Pharma media release, company announced that it has received the approval of its Pediatric Investigation Plan (PIP) by the EMA Pediatric Committee, DSMB completed its final safety assessment of the pivotal Phase 3 trial ARES. Submission of a Centralized Marketing Authorization Application (MAA) to the EMA is expected in June 2025.
    • 08 Jan 2025 Primary endpoint (ORR of gastro intestinal-aGvHD) has been met, as per results presented in a MaaT Pharma media release.

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