FDA lifts clinical hold on phase III investigational NDA for MaaT 013 in patients with acute graft-versus-host disease
MaaT Pharma a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to improving survival outcomes for patients with cancer, reported that the FDA 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 III pivotal clinical trial evaluating the safety and efficacy of MaaT 013 to treat gastrointestinal acute Graft-versus-Host Disease (aGvHD) as a third line of treatment
In parallel to the resolution of the clinical hold with the FDA, the development of MaaT 013 has significantly progressed in the ongoing international multicenter open-label, single arm, pivotal Phase III trial (ARES) launched in March 2022 in Europe, along with the ongoing accumulation of encouraging data from the Early Access Program.
In this context, before initiating clinical activities in the U.S., MaaT Pharma intends to consult with the FDA on the next steps of the regulatory process to bring Maa 013 to US patients in the most expeditious way possible while the Company continues the late-stage clinical development of MaaT 013 in Europe.
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