It’s outlining Path Forwardfor Investigational New Drug Application for MaaT013 in Patients with Acute Graft-verus-Host Disease
Lyon, France, February 3, 2023 – 7:30 am CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported that the U.S. Food and Drug Administration (FDA or the “Agency”) has responded to the Company’s Investigational New Drug (IND) Application to initiate in the U.S. an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy of MaaT013 in patients with steroid-resistant acute Graft-versus-Host Disease (aGvHD).
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.