木薯科学公司在另一项三期试验失败后，停止开发阿尔茨海默病药物Simufilam-动脉网

Cassava Sciences Discontinues Developing Simufilam For Alzheimer's After Another Phase 3 Trial Flop

benzinga 等信源发布 2025-03-25 10:42

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Cassava Sciences Inc.

卡萨瓦科学公司

SAVA

萨瓦

on Tuesday shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-

周二分享了 simufilam 在轻度至中度阿尔茨海默病的 3 期 REFOCUS-ALZ 研究的初步结果。

moderate Alzheimer’s disease

中度阿尔茨海默病

。

REFOCUS-ALZ randomized approximately 1,125 people utilizing the same eligibility

REFOCUS-ALZ 随机抽取了大约 1,125 名符合相同资格条件的人

criteria as RETHINK-ALZ

标准如RETHINK-ALZ

。

Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints.

顶线数据显示，REFOCUS-ALZ 未能达到每个预先设定的共同主要、次要和探索性生物标志物终点。

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另请阅读：

Cassava Sciences Alzheimer’s Drug Fails To Hit Primary Goal In Pivotal Study, Pharma Halts Late-Stage Studies

Cassava Sciences的阿尔茨海默病药物在关键研究中未能达到主要目标，制药公司停止了晚期研究。

The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo.

共同主要终点是从基线到第76周双盲治疗期结束时，通过ADAS-COG12和ADCS-ADL量表评估的认知和功能变化，比较simufilam与安慰剂的效果。

On ADAS-COG12 (cognitive scale, where lower numbers mean less cognitive impairment), scores rose by 4.97 and 5.26 points in the two simufilam cohorts and by 4.70 points in the placebo group.

在ADAS-COG12（认知量表，数字越低表示认知障碍越少）上，两个simufilam组的得分分别增加了4.97和5.26点，而安慰剂组的得分增加了4.70点。

Similarly, on ADCS-ADL (daily living where a higher number represents less functional impairment), scores fell by 6.27 and 6.43 points on simufilam arms and by 5.32 points on placebo.

同样，在ADCS-ADL（日常生活能力，数值越高表示功能损伤越少）方面，服用simufilam的患者评分分别下降了6.27和6.43分，而安慰剂组下降了5.32分。

REFOCUS-ALZ was discontinued in November following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints.

REFOCUS-ALZ 在报告前一项为期 52 周的 III 期研究 RETHINK-ALZ 未达到其共同主要终点后，于 11 月停止。

A large portion of subjects enrolled in REFOCUS-ALZ completed their final study visit prior to the termination of the trial. Simufilam continued to demonstrate an overall favorable safety profile.

REFOCUS-ALZ 试验中很大一部分受试者在试验终止前完成了最终研究访视。Simufilam 继续表现出总体良好的安全性。

“We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease. These results were unambiguous,” said Cassava Chief Executive

“我们对REFOCUS-ALZ和RETHINK-ALZ的结果感到失望，结果显示对于轻至中度阿尔茨海默病患者没有治疗益处。这些结果是明确的，”Cassava首席执行官表示。

Rick Barry

里克·巴里

。

“Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the program by the end of Q2 2025,” Barry continued.

“Cassava将停止所有开发simufilam用于阿尔茨海默病的努力，我们预计将在2025年第二季度末逐步结束该项目，”巴里继续说道。

In February, Cassava Sciences entered into an agreement with Yale University for a license to intellectual property rights, including an exclusive license to an issued US method of treatment patent for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders, including .

今年2月，Cassava Sciences与耶鲁大学达成协议，获得了知识产权许可，包括针对罕见神经发育障碍相关癫痫的simufilam潜在治疗方法的美国已授权治疗专利的独家许可。

tuberous sclerosis complex

结节性硬化症

。

Price Action:

价格行为:

SAVA stock is down 22.1% at $2.18 at the last check Tuesday.

周二最后一次检查时，SAVA股票下跌了22.1%，至2.18美元。

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