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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: 09 Jun 2026

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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

  • 20 May 2026 According to a MaaT Pharma media release, company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.
  • 20 May 2026 According to a MaaT Pharma media release, company has been informed by the CHMP of the EMA of a "negative trend" opinion on its conditional Marketing Authorization Application (MAA) for MaaT013. The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application within 60 calendar days supported by clinical data from ARES study, and real-world data with the ongoing Early Access Program.
  • 23 Mar 2026 According to a MaaT Pharma media release, company presented the final results from the Phase 3 ARES single-arm pivotal trial evaluating MaaT013 in acute Graft-versus-Host Disease (aGvHD). The presentation took place during the Presidential Plenary Session at the 2026 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Madrid, Spain.

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