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Cytokinetics Presents Additional Data From SEQUOIA-HCM At The HCMS Scientific Sessions; Says "Overall, 83.8% Of Patients Treated With Aficamten Experienced Favorable Effects In At Least One Of The Five Domains, Compared To 39.3% Of Patients On Placebo"

Cytokinetics Presents Additional Data From SEQUOIA-HCM At The HCMS Scientific Sessions; Says "Overall, 83.8% Of Patients Treated With Aficamten Experienced Favorable Effects In At Least One Of The Five Domains, Compared To 39.3% Of Patients On Placebo"

细胞动力学在HCMS科学会议上发布了来自SEQUOIA-HCm的额外数据;称"总体而言,83.8%接受Aficamten治疗的患者在至少五个领域中经历了良好效果,相比39.3%的安慰剂组患者"
Benzinga ·  09/27 11:02

Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania.

纳斯达克上市公司Cytokinetics今天宣布,在患有症状性梗阻性肥厚型心肌病(HCM)的患者中,来自SEQUOIA-HCm(Aficamten在HCM中的安全性、有效性和梗阻影响的定量理解)关键3期临床试验的额外数据已由宾夕法尼亚大学遗传性心脏病中心的董事兼医学助理教授Anjali t. Owens万博士在肥厚性心肌病医学会(HCMS)科学会议上发布。

A new analysis from SEQUOIA-HCM showed that treatment with aficamten was associated with beneficial changes in five indices reflecting structural, electrophysiologic and biomarker changes in patients from SEQUOIA-HCM. This analysis was performed in patients treated with aficamten and compared to placebo, at 24 weeks as follows:

来自SEQUOIA-HCm的新分析显示,用aficamten治疗与患者结构、电生理和生物标志物变化相关的五个指数有益变化。此分析是在接受aficamten治疗,与安慰剂相比的患者进行的,在24周内如下:

  • Improvement in maximal wall thickness by ≥1.5 mm (n = 282; 47.9% vs 30.7%; p=0.003)
  • Improvement in left atrial volume index (LAVI) category in those with mild, moderate, or severe enlargement at baseline (n = 185; 46.8% vs. 18.7%; p<0.001)
  • Resolution of ECG changes consistent with left ventricular hypertrophy (n = 282; 19.0% vs. 4.3%; p<0.001)
  • Normalization of hyperdynamic left ventricular ejection fraction (defined as ≥72%) into the normal range (n = 282; 35.2% vs 20.7%; p<0.007)
  • Reduction in NT-proBNP by ≥50% from baseline (n = 282; 81.7% vs. 7.1%; p<0.001).
  • 最大壁厚度改善≥1.5毫米(n = 282; 47.9% vs 30.7%; p=0.003)
  • 在基线轻度、中度或重度扩大者中改善左心房容积指数(LAVI)类别(n = 185; 46.8% vs. 18.7%; p
  • 解决与左室肥厚一致的心电图变化(n = 282; 19.0% vs. 4.3%; p
  • 将超动力左室射血分数(定义为≥72%)归为正常范围的正常化(n = 282; 35.2% vs 20.7%; p
  • 从基线减少Nt-proBNP≥50%(n = 282; 81.7% vs. 7.1%; p

Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (p<0.001, NNT = 2.2).

总体而言,83.8%接受aficamten治疗的患者在五个领域中至少有一个有利影响,而安慰剂组中仅有39.3%的患者(p

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