MaaT Pharma Faces Setback with CHMP Decision on MaaT013

MaaT Pharma announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) maintained a negative opinion on the Conditional Marketing Authorization application for MaaT013 (Xervyteg®). This decision follows a re-examination process where the company proposed a Phase 3 trial named PHOENIX, aiming at gathering more evidence about the treatment's benefit-risk profile.

The PHOENIX trial is designed as a randomized, controlled Phase 3 study comparing MaaT013 to the Best Available Therapy in patients with acute Graft-versus-Host Disease that is refractory to previous treatments. Subject to funding and regulatory clearance, it is planned to start in 2027, with potential first patient enrollment in the first half of 2027.

Despite the setback in Europe, the U.S. FDA provides support for advancing the PHOENIX trial, hinting at future global regulatory submissions. MaaT Pharma emphasizes the strategic review and cash preservation measures to extend operational capacity.