CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington’s Disease (HD). In the study, dalzanemdor did not demonstrate a statistically significant difference versus placebo on the primary endpoint, the change from baseline on the Symbol Digit Modalities Test (SDMT) at Day 84.

马萨诸塞州剑桥市。-（商业新闻短讯）--Sage Therapeutics，Inc.（纳斯达克：Sage）今天宣布了达尔扎内姆多（Sage-718）在与亨廷顿舞蹈病（HD）相关的认知障碍（CI）参与者中进行的第二阶段维度研究的结果。在这项研究中，dalzanemdor在主要终点与安慰剂相比没有显示出统计学上的显着差异，即在第84天的符号数字模式测试（SDMT）中从基线的变化。

Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Based on these results, the Company does not plan further development of dalzanemdor..

与安慰剂相比，次要终点的分析没有显示用达尔扎涅姆多治疗的参与者在统计学上显着或临床上有意义的差异。根据这些结果，公司不计划进一步开发dalzanemdor。。

“We are disappointed by the results of the DIMENSION Study, especially for the individuals and families affected by Huntington’s Disease who have long awaited new treatment options,” said Barry Greene, Chief Executive Officer, Sage Therapeutics. “Innovation is desperately needed, and we are immensely grateful to the participants, investigators, and the entire Huntington’s Disease community whose unwavering commitment to advancing research helped make this study possible.”.

Sage Therapeutics首席执行官巴里·格林（BarryGreene）表示：“我们对DIMENSION研究的结果感到失望，尤其是对于那些长期等待新治疗方案的亨廷顿舞蹈症患者和家庭来说。”。“迫切需要创新，我们非常感谢参与者，研究人员和整个亨廷顿舞蹈症社区，他们对推进研究的坚定承诺使这项研究成为可能。”。

The DIMENSION Study was a 12-week, double-blind, placebo-controlled Phase 2 study to evaluate the effects of dalzanemdor in participants with CI associated with HD. A total of 189 participants were randomized.

DIMENSION研究是一项为期12周的双盲安慰剂对照2期研究，旨在评估dalzanemdor对与HD相关的CI参与者的影响。共有189名参与者被随机分配。

The DIMENSION Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the SDMT, a measure of cognitive function, at Day 84, the primary endpoint.

在主要终点第84天，在SDMT（一种认知功能的量度）上，用达尔扎涅姆多治疗的参与者与安慰剂治疗的参与者相比，维度研究没有显示出与基线相比的统计学显着差异。

Dalzanemdor was generally well-tolerated and no new safety signals were observed. The majority of treatment emergent adverse events were mild to moderate in severity.

Dalzanemdor通常耐受性良好，没有观察到新的安全信号。大多数治疗紧急不良事件的严重程度为轻度至中度。

Analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences between the dalzanemdor and placebo treatment groups.

次要终点的分析没有显示达尔扎涅姆多组和安慰剂治疗组之间的统计学显着性或临床意义上的差异。

Given these findings, the Company also will close the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.

鉴于这些发现，该公司还将结束正在进行的权限研究，这是一项针对HD参与者的dalzanemdor开放标签安全性研究。

About Sage Therapeutics

关于Sage Therapeutics

Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a pipeline to target unmet needs in brain health.

Sage Therapeutics（纳斯达克股票代码：Sage）是一家生物制药公司，致力于提供改变生命的大脑健康药物的开创性解决方案，使每个人都能茁壮成长。Sage开发了仅有的两种FDA批准的产后抑郁症治疗方法，并正在推进针对大脑健康未满足需求的管道。

Sage was founded in 2010 and is headquartered in Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X..

Sage成立于2010年，总部位于马萨诸塞州剑桥。有关更多信息，请访问www.sagerx.com，或在Facebook、LinkedIn、Instagram和X上与我们联系。。