Agios Phase 3 Met Primary, All Key Secondary Endpoints in Transfusion-Dependent Alpha- or Beta-Thalassemia

 

• Study Achieved the Primary Endpoint; Mitapivat Demonstrated a Statistically Significant Transfusion Reduction Response Compared to Placebo
• Statistical Significance Achieved for All Key Secondary Endpoints Evaluating Additional Measures of Reduction of Transfusion Burden Compared to Placebo
• ENERGIZE-T is the First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia
• As Part of Global Submission Strategy, U.S. Marketing Application for Mitapivat in Thalassemia Based on ENERGIZE and ENERGIZE-T Studies to be Submitted by End of 2024
• Agios to Host Investor Webcast Event Today at 8:00 a.m. ET

Agios plans to present a more detailed analysis of the Phase 3 ENERGIZE-T data at an upcoming medical meeting. Data from the Phase 3 ENERGIZE study of mitapivat in non-transfusion-dependent thalassemia will be presented at the European Hematology Association 2024 Hybrid Congress in a plenary session on June 15, 2024, and in a poster session on June 14, 2024.

Conference Call Information

Agios will host a webcast investor event today at 8:00 a.m. ET to review the ENERGIZE-T Phase 3 data and next steps for the mitapivat development program in thalassemia. The event can be accessed under “Events & Presentations” in the Investors and Media section of the company's website at www.agios.com. The archived webcast will be available on the company's website beginning approximately two hours after the event.

https://www.biospace.com/article/releases/agios-announces-phase-3-energize-t-study-of-mitapivat-met-primary-endpoint-and-all-key-secondary-endpoints-in-adults-with-transfusion-dependent-alpha-or-beta-thalassemia/