Agios Pharmaceuticals Inc. (AGIO) has reported promising outcomes from the global Phase 3 ENERGIZE study evaluating mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia.
The ENERGIZE study successfully met its primary endpoint, with mitapivat showing a statistically significant increase in hemoglobin response rate when compared to placebo. Furthermore, statistical significance was achieved with key secondary endpoints, which included changes from baseline in the FACIT-Fatigue Score and hemoglobin concentration. These beneficial effects were consistent across all pre-specified subgroups.
"The ENERGIZE data shared at this congress indicate that non-transfusion-dependent alpha- or beta-thalassemia patients receiving mitapivat experienced meaningful clinical improvements in fatigue, walking capacity, and various patient-reported outcomes," said Dr. Kevin Kuo, MSc, FRCPC, from the Division of Hematology at the University of Toronto, Canada, and an investigator in the ENERGIZE study.
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