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.
周一，Edgewise Therapeutics, Inc.（纳斯达克股票代码：EWTX）公布了针对贝克尔肌肉萎缩症（BMD）患者的CANYON二期试验的主要结果，贝克尔肌肉萎缩症（BMD）是一种导致进行性肌肉无力的遗传性疾病。
Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced damage in muscular dystrophies.
Sevasemten是一种口服给药的同类首创的快速骨骼肌球蛋白抑制剂，旨在保护肌肉免受肌肉萎缩引起的损伤。
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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是迄今为止最大的BMD介入试验，也是第一个实现其主要终点的试验。该试验在40名成人和29名青少年中进行。
The trial met its primary endpoint of change from baseline in creatine kinase (CK).
该试验达到了肌酸激酶（CK）与基线相比变化的主要终点。
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sevasemten治疗组中，Ck与基线相比有显著变化（与安慰剂的差异，在第6至12个月中平均下降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.
北极星门诊评估（NSAA，运动功能的变化）是功能的关键次要终点，在sevasemten治疗组中，随着时间的推移显示出改善的趋势。
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）是快速骨骼肌损伤的靶标特异性生物标志物，与安慰剂相比，显示出显著降低。
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.
与安慰剂相比，其他功能指标，包括10米步行/跑步、4层楼梯和100米计时测试，显示出改善的趋势。
The treatment population had more advanced disease than placebo.
治疗人群的疾病比安慰剂更晚期。
Sevasemten was well-tolerated, and no new safety concerns were observed.
Sevasemten的耐受性良好，没有观察到新的安全问题。
The company is on track to complete recruitment in the GRAND CANYON cohort by the first quarter of 2025.
该公司有望在2025年第一季度之前完成大峡谷人才的招聘。
Price Action: EWTX stock is up 8.62% at $30 at last check Monday.
价格走势：周一最后一次检查时，EWTX股价上涨8.62％，至30美元。
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