After Disappointing Parkinson's Data, Sage Therapeutics' Dalzanemdor Flunks Mid-Stage Alzheimer's Study
After Disappointing Parkinson's Data, Sage Therapeutics' Dalzanemdor Flunks Mid-Stage Alzheimer's Study
Based on these data, the company does not plan further clinical development of dalzanemdor in Alzheimer's. The company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington's Disease later this year.Tuesday, Sage Therapeutics, Inc. (NASDAQ:SAGE) released topline results from the Phase 2 LIGHTWAVE study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD).
周二，Sage Therapeutics, Inc.（纳斯达克股票代码：SAGE）公布了2期LIGHTWAVE研究的主要结果，该研究旨在评估达尔扎奈姆（SAGE-718）对因阿尔茨海默氏病（AD）导致的轻度认知障碍（MCI）或轻度痴呆参与者的影响。
The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the study's primary outcome measure.
根据该研究的主要结果衡量标准，在韦克斯勒成人智力量表第四版（WAIS-IV）编码测试分数上，接受dalzanemdor治疗的参与者与安慰剂治疗的参与者在第84天没有显示出统计学上的显著差异。
The WAIS-IV test assesses the intellectual abilities of people aged between 16 and 90. A total of 174 participants were randomized.
WAIS-IV测试评估年龄在16至90岁之间的人的智力能力。共有 174 名参与者被随机分配。
Based on these data, the company does not plan further clinical development of dalzanemdor in Alzheimer's. The company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington's Disease later this year.
根据这些数据，该公司不计划进一步开发用于阿尔茨海默氏症的dalzanemdor的临床开发。该公司预计将在今年晚些时候公布针对与亨廷顿氏病相关的认知障碍患者的dalzanemdor的2期DIMENSION研究的主要数据。
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的耐受性总体良好，没有观察到新的安全信号。大多数治疗中出现的不良事件的严重程度为轻度至中度。
Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as Repeatable Battery for Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA), both cognitive tests.
分析表明，接受dalzanemdor治疗的组与安慰剂在探索性终点方面没有任何有意义的差异，例如神经心理状态评估的可重复电池（RBANS）和蒙特利尔认知评估（MoCA），这两项认知测试。
Earlier this year, PRECEDENT Phase 2 study of dalzanemdor in people with mild cognitive impairment in Parkinson's Disease also failed to meet its primary endpoint.
今年早些时候，针对帕金森氏病轻度认知障碍患者的precendor的dalzanemdor的2期研究也未能达到其主要终点。
In September, Sage Therapeutics announced that Biogen Inc (NASDAQ:BIIB) terminated its rights under the collaboration and license agreement with Sage, which was specific to the SAGE-324 program.
9月，Sage Therapeutics宣布，百健公司（纳斯达克股票代码：BIIB）终止了与Sage签订的合作和许可协议规定的权利，该协议专门针对 SAGE-324 计划。
The companies recently announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET.
两家公司最近宣布了用于慢性治疗特发性震颤（ET）的在研药性 SAGE-324 的 2 期 KINETIC 2 研究的阴性结果，并停止了美国东部时间 SAGE-324 的进一步临床开发。
Price Action: At last check on Tuesday, SAGE stock was down 11.30% at $5.96 during the premarket session.
价格走势：在周二的最后一次检查中，SAGE股价在盘前交易时段下跌了11.30％，至5.96美元。
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