Update on FDA NDA for MaaT 013 in patients with acute graft-versus-host disease.- MaaT Pharma

The FDA letter indicates that the Agency agrees to a defined list of conditions that could enable clinical evaluation of MaaT013 in the U.S. These measures will be included, by the Company, in the IND filing. The communication therefore provides a path forward regarding MaaT Pharma’s “pooling” technology for this IND. The Company will promptly prepare a complete response letter and in the interim, the clinical hold remains.

As announced in August 2022, the FDA had requested further clinical and manufacturing-related information including data on the safety and efficacy of the Company’s “pooling” technology approach (i.e., mixing donations from multiple donors to achieve higher richness, diversity, and better standardization of the product). The Company submitted to the FDA detailed responses to these requests as announced in the press release dated January 24, 2023. In parallel, and as a reminder, the Company continues the development of MaaT 013 in Europe with its ongoing international multicenter open-label, single arm, pivotal Phase III trial “ARES” evaluating MaaT013, which is progressing as planned. A review by an independent data safety and monitoring board (DSMB), is expected in the first half of 2023 after enrollment of half of the patients in the study.