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.
全球货币领域的领导者Agios Pharmaceuticals, Inc. ( 纳斯达克股票代码:AGIO ) 今天在西班牙马德里举行的2024年欧洲血液学会(EHA2024)混合大会的主题会议上(摘要#S104)公布了来自全球第三期ENERGIZE研究关于mitapivat在成年非输血性(NTD)α-或β-地中海贫血患者中的详细结果。在相关海报演示(摘要#P1529)中，该公司呈现了ENERGIZE研究的额外数据，强调mitapivat组患者在健康相关生命质量和患者报告的结果方面与安慰剂组相比有显著改善。
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研究实现了其主要终点，mitapivat与安慰剂相比显示出统计学上显著的血红蛋白反应率增加。两个关键的次要终点与基线相比的FACIT疲劳评分和血红蛋白浓度的变化也取得了统计学上的显著性。这些改善在所有预指定的亚组中观察到。