MaaT Pharma 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. MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (group of bacterial genera known to produce immuno-regulatory metabolites). It aims to restore the symbiotic relationship between the patient's functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and reduce steroid-resistant, gastrointestinal-predominant aGvHD.

MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use.