MaaT Pharma receives positive DSMB review for Phase 3 trial of MaaT013 in acute Graft-versus-Host Disease.
M2 EQUITYBITES-October 26, 2023-MaaT Pharma receives positive DSMB review for Phase 3 trial of MaaT013 in acute Graft-versus-Host Disease
(C)2023 M2 COMMUNICATIONS http://www.m2.co.uk
Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) announced on Thursday that the Data Safety Monitoring Board (DSMB) has unanimously recommended the continuation of the open-label, single-arm pivotal Phase 3 clinical trial, ARES, assessing MaaT013 in acute Graft-versus-Host Disease (aGvHD).
A review by the DSMB examined the trial's safety, efficacy and protocol adherence, and affirmed a favourable benefit/risk ratio, characterising MaaT013 as having "high efficacy and low toxicity" in the patient population. The Overall Response Rate (ORR) exceeded pre-defined protocol assumptions, reinforcing confidence in the trial.
The DSMB's assessment of safety validated that there were no safety concerns based on data from 30 reviewed patients. MaaT013...
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