in Acute Graft-versus-Host Disease with MaaT013
The independent Data Safety Monitoring Board (DSMB), after careful review of safety, efficacy, and protocol adherence, has unanimously recommended that the trial continues without modification.
The DSMB concluded on a positive benefit/risk ratio based on a good safety profile and positive preliminary efficacy results with an Overall Response Rate higher than pre-defined protocol assumptions.
Lyon, France, October 26, 2023 – 7:30 am CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today announced that the DSMB unanimously recommended that the open-label, single arm pivotal Phase 3 clinical trial evaluating MaaT013 in acute Graft-versus-Host Disease (aGvHD), named ARES, continues without modification. The Overall Response Rate (ORR) was superior to pre-defined protocol assumptions. Therefore, the DSMB concluded that the benefit/risk ratio with “high efficacy and low toxicity” was favorable in this patient population.