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细胞动力学宣布ACACIA-HCM开始,这是Aficamten在症状性非梗阻性肥厚型心肌病患者中的关键3期临床试验

Cytokinetics Announces Start of ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

globenewswire 等信源发布 2023-09-06 19:30

可切换为仅中文


SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), is open to enrollment.

加利福尼亚州南旧金山,2023年9月6日(GLOBE NEWSWIRE)-Cytokinetics,Incorporated(纳斯达克股票代码:CYTK)今天宣布ACACIA-HCM(评估Aficamten与安慰剂对非阻塞性成人心脏终点的比较HCM),阿法卡坦治疗症状性非阻塞性肥厚型心肌病(nHCM)患者的3期临床试验正在开放。

Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM. “As the first Phase 3 clinical trial of aficamten in non-obstructive hypertrophic cardiomyopathy, ACACIA-HCM represents an important advancement in the development program for aficamten alongside our two ongoing Phase 3 clinical trials in obstructive HCM,” said Fady I.

Aficamten是正在开发的用于潜在治疗HCM的下一类心肌肌球蛋白抑制剂。Fady I说:“作为aficamten在非阻塞性肥厚型心肌病中的第一个3期临床试验,ACACIA-HCM代表了aficamten开发计划的重要进展,同时我们正在进行两项阻塞性HCM的3期临床试验。”。

Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “ACACIA-HCM builds on the encouraging findings from Cohort 4 of REDWOOD-HCM, the Phase 2 clinical trial which demonstrated that treatment with aficamten resulted in statistically significant improvements in heart failure symptoms and cardiac biomarkers in patients with non-obstructive HCM.

Malik,M.D.,博士,细胞动力学研究与开发执行副总裁。“ACACIA-HCM建立在REDWOOD-HCM队列4的令人鼓舞的发现基础上,这是一项2期临床试验,该试验表明,使用阿非卡明治疗可显着改善非阻塞性HCM患者的心力衰竭症状和心脏生物标志物。

In ACACIA-HCM we look forward to assessing the impact of aficamten in patients with non-obstructive HCM on symptoms and quality of life as well as on other measures of disease burden, including exercise capacity, functional class, cardiac structure and function and cardiovascular outcomes.” ACACIA-HCM: Clinical Trial Design ACACIA-HCM is a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo on health-related quality of life in participants with symptomatic nHCM.

在ACACIA-HCM,我们期待评估非阻塞性HCM患者中的阿非卡坦对症状和生活质量的影响,以及其他疾病负担指标,包括运动能力,功能分级,心脏结构和功能以及心血管结局。”ACACIA-HCM:临床试验设计ACACIA-HCM是一项3期,多中心,随机,双盲,安慰剂对照的临床试验,旨在评估阿非卡坦与安慰剂相比对参与者健康相关生活质量的影响。有症状的nHCM。

The primary endpoint is the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary.

主要终点是堪萨斯城心肌病问卷(KCCQ)临床总结的变化。