Hold on Phase 3 Investigational New Drug Application for MaaT013 in Patients with Acute Graft-versus-Host Disease.
Lyon, France, April 24, 2023, 7:30 am CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader 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 lifted the clinical hold and cleared the 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 to treat gastrointestinal acute Graft-versus-Host Disease (aGvHD) as a third line of treatment.