Agios Announced Earlier Results From Its Phase 3 ENERGIZE Study Of Mitapivat In Non-Transfusion-Dependent Thalassemia; Study Achieved Its Primary Endpoint
Agios Announced Earlier Results From Its Phase 3 ENERGIZE Study Of Mitapivat In Non-Transfusion-Dependent Thalassemia; Study Achieved Its Primary Endpoint
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today presented detailed results from the global Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia in a plenary session (abstract #S104) at the European Hematology Association 2024 (EHA2024) Hybrid Congress, which is being held June 13-16, 2024, in Madrid, Spain. In a related poster presentation (abstract #P1529), the company presented additional data from the ENERGIZE study highlighting clinically meaningful improvements in health-related quality of life measures and patient-reported outcomes among patients in the mitapivat arm compared to those in the placebo arm.
全球貨幣領域的領導者Agios Pharmaceuticals, Inc. ( 納斯達克股票代碼:AGIO ) 今天在西班牙馬德里舉行的2024年歐洲血液學會(EHA2024)混合大會的主題會議上(摘要#S104)公佈了來自全球第三期ENERGIZE研究關於mitapivat在成年非輸血性(NTD)α-或β-地中海貧血患者中的詳細結果。在相關海報演示(摘要#P1529)中，該公司呈現了ENERGIZE研究的額外數據，強調mitapivat組患者在健康相關生命質量和患者報告的結果方面與安慰劑組相比有顯著改善。
The ENERGIZE study achieved its primary endpoint, with mitapivat demonstrating a statistically significant increase in hemoglobin response rate compared to placebo. Statistical significance was also achieved for both key secondary endpoints associated with change from baseline in FACIT-Fatigue Score and hemoglobin concentration. These improvements were observed across all pre-specified subgroups.
ENERGIZE研究實現了其主要終點，mitapivat與安慰劑相比顯示出統計學上顯著的血紅蛋白反應率增加。兩個關鍵的次要終點與基線相比的FACIT疲勞評分和血紅蛋白濃度的變化也取得了統計學上的顯著性。這些改善在所有預指定的亞組中觀察到。