Edgewise Therapeutics' Lead Candidate Reduces Biomarker Levels In Mid-Stage Study In Patients With Muscle Weakness Disease
Edgewise Therapeutics' Lead Candidate Reduces Biomarker Levels In Mid-Stage Study In Patients With Muscle Weakness Disease
The company adds that CANYON is the largest interventional trial to date in BMD and the first to achieve its primary endpoint. The trial was conducted among 40 adults and 29 adolescents.On Monday, Edgewise Therapeutics, Inc., (NASDAQ:EWTX) revealed topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy (BMD), is a genetic disorder that causes progressive muscle weakness.
在周一，Edgewise Therapeutics, Inc.（纳斯达克：EWTX）公布了针对贝克肌肉营养不良症（BMD）患者的第二阶段CANYON试验的顶线结果，BMD是一种导致肌肉逐渐无力的遗传疾病。
Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced damage in muscular dystrophies.
Sevasemten是一种口服给药的首创类快速骨骼肌肌球蛋白抑制剂，旨在保护肌肉免受肌肉营养不良症中由收缩引起的损伤。
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The company adds that CANYON is the largest interventional trial to date in BMD and the first to achieve its primary endpoint. The trial was conducted among 40 adults and 29 adolescents.
该公司补充说，CANYON是迄今为止在BMD治疗中最大的干预试验，也是第一个达到主要终点的试验。该试验在40名成年人和29名青少年中进行。
The trial met its primary endpoint of change from baseline in creatine kinase (CK).
该试验达到了主要终点，即肌酸激酶（CK）从基线的变化。
The results demonstrated a significant change from baseline in CK in the sevasemten-treated group (difference vs. placebo, 28% average decrease over months 6 through 12; p=0.02).
结果显示，在接受sevasemten治疗的组中，CK从基线的变化显著（与安慰剂相比，6至12个月的平均减少为28%；p=0.02）。
North Star Ambulatory Assessment (NSAA, a change in motor function), the key secondary endpoint of function, showed a trend towards improvement over time in the sevasemten-treated group.
北星步态评估（NSAA，运动功能的变化）作为功能的关键次要终点，显示出在sevasemten治疗组中随着时间的推移呈现改善的趋势。
Plasma fast skeletal muscle troponin I (TNNI2), a target-specific biomarker of fast skeletal muscle damage, showed a significant reduction compared to placebo.
血浆快速骨骼肌肌钙蛋白I（TNNI2），作为快速骨骼肌损伤的靶向特异性生物标志物，显示相比于安慰剂有明显减少。
Additional functional measures, including the 10-meter walk/run, 4-stair climb, and 100-meter timed test, showed trends toward improvement compared to the placebo.
其他功能性测量，包括10米步行/运行、4阶梯攀爬和100米计时测试，显示出与安慰剂相比有改善趋势。
The treatment population had more advanced disease than placebo.
治疗人群的疾病比安慰剂更为严重。
Sevasemten was well-tolerated, and no new safety concerns were observed.
Sevasemten耐受性良好，未观察到新的安全隐患。
The company is on track to complete recruitment in the GRAND CANYON cohort by the first quarter of 2025.
公司计划在2025年第一季度之前完成大峡谷队列的招募。
Price Action: EWTX stock is up 8.62% at $30 at last check Monday.
价格动态：EWTX股票在周一最后检查时上涨8.62%，目前价格为30美元。
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