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卫材将开始对嗜睡症患者进行二期研究的招募工作

EISAI TO BEGIN ENROLLING PHASE 2 STUDY IN PATIENTS WITH NARCOLEPSY

CISION 等信源发布 2026-03-26 20:00

可切换为仅中文


NUTLEY, N.J.

纽特利,新泽西州

,

March 26, 2026

2026年3月26日

/PRNewswire/ -- Eisai Inc. announced today that screening for global Study E2086-G000-202 (Study 202) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on

/PRNewswire/ -- 卫材公司今天宣布,用于评估新型选择性食欲素-2受体E2086的疗效、安全性和耐受性的全球研究E2086-G000-202(研究202)现已注册在

ClinicalTrials.gov as NCT07493265

ClinicalTrials.gov 注册号为 NCT07493265

. Study sites are also planned for Canada, China, Europe, Japan, and South Korea.

此外,还计划在加拿大、中国、欧洲、日本和韩国设立研究站点。

Study 202 is a three-period, dose escalation study in adult patients with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2). Three dose strengths of E2086 per NT1 or NT2 participants will be assessed compared with placebo using objective and patient-reported measures of wake promotion.

研究202是一项为期三个阶段、剂量递增的研究,针对1型嗜睡症(NT1)或2型嗜睡症(NT2)的成年患者。将通过客观和患者报告的清醒促进措施,评估三种不同剂量强度的E2086与安慰剂在NT1或NT2参与者中的效果。

Narcolepsy is a sleep disorder resulting from disorganization of the sleep/wakefulness cycle. In patients with NT1, excessive daytime sleepiness and cataplexy (acute episodes of loss of muscle tone) are reported in association with low levels of the neurotransmitter orexin. In patients with NT2, excessive daytime sleepiness occurs, but without reports of cataplexy..

嗜睡症是一种由睡眠/清醒周期紊乱导致的睡眠障碍。在1型嗜睡症(NT1)患者中,据报道白天过度嗜睡和猝倒(急性肌肉张力丧失发作)与神经递质食欲素水平低有关。在2型嗜睡症(NT2)患者中,出现白天过度嗜睡,但没有猝倒的报告。

As a selective orexin-2 receptor agonist, E2086 is hypothesized to compensate for the loss of orexin in patients with narcolepsy. In nonclinical studies, E2086 was shown to increase wake time and decrease cataplexy-like episodes in narcolepsy model mice and to prolong wakefulness in wild-type mice.

作为一种选择性的食欲素-2受体激动剂,E2086被认为可以补偿嗜睡症患者体内食欲素的缺失。在非临床研究中,E2086在嗜睡症模型小鼠中显示出能够增加清醒时间并减少类似猝倒的发作,同时延长野生型小鼠的清醒时间。

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In a recently completed proof-of-mechanism study in patients with NT1, compared with placebo and an existing treatment (modafinil), E2086 provided statistically significant and clinically meaningful increases in wake time as assessed by the objective maintenance of wakefulness test and by the patient-reported Karolinska sleepiness scale..

在最近完成的一项针对NT1患者的机制验证研究中,与安慰剂和现有治疗(莫达非尼)相比,E2086在通过客观觉醒维持测试以及患者报告的卡罗林斯卡嗜睡量表评估中,显示出统计学显著且临床意义重大的清醒时间延长。

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For information about this study, please contact Eisai Medical Information at

有关本研究的信息,请联系卫材医疗信息部

https://www.eisaimedicalinformation.com/

https://www.eisaimedicalinformation.com/

or 1-888-274-2378 (Monday through Friday 8:30 AM – 5:00 PM EST, excluding holidays).

或 1-888-274-2378(周一至周五上午 8:30 至下午 5:00 东部标准时间,节假日除外)。

About E2086

关于E2086

E2086 is Eisai's in-house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels.

E2086是卫材公司自主研发的新型选择性食欲素2受体激动剂。非临床研究已表明,其在清醒时间上有统计学意义上的显著增加,并显著降低了猝倒的发生率。食欲素缺乏的个体表现出白天过度嗜睡(EDS),例如1型嗜睡症患者,他们的食欲素能神经元丧失,脑脊液(CSF)中食欲素水平较低。

E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity..

E2086 有可能通过增强食欲素受体活性来改善患者的症状。

About Eisai Inc.

关于卫材公司

Eisai Inc. is a

卫材公司是

human health care

人类健康护理

(

(

hhc

hhc

) company dedicated to improving the lives of people affected by cancer, Alzheimer's disease and other neurodegenerative conditions. Everything we do is guided by the simple principle that patients and their families come first, and we have a responsibility to listen to and learn from them.

)一家致力于改善受癌症、阿尔茨海默病和其他神经退行性疾病影响的人们生活的公司。我们所做的一切都遵循一个简单的原则,即患者及其家属是最重要的,我们有责任倾听并从中学习。

Our

我们的

hhc

hhc

mission is the shared purpose that connects us to those we serve. It creates a network of powerful relationships that enable us to identify, understand and address unmet needs and healthcare disparities as we work towards achieving societal good.

使命是我们与服务对象之间的共同目标。它构建了一个强大的关系网络,使我们能够识别、理解并解决未满足的需求和医疗不平等问题,从而为实现社会福祉而努力。

Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Our U.S. operations include discovery, research and development; manufacturing; global supply and logistics; and commercial activities.

东京的卫材株式会社是一家以研发为主的全球制药公司,其美国子公司为卫材美国公司。我们美国业务包括探索、研究与开发、生产、全球供应和物流以及商业活动。

To learn more, please visit us at

要了解更多信息,请访问我们网站

https://us.eisai.com

https://us.eisai.com

and connect with us on

并关注我们

X

X

and

LinkedIn

领英

. For more information on our research, follow our dedicated neurology (

如需更多关于我们研究的信息,请关注我们专门的神经学(

LinkedIn

领英

and

X

X

) and oncology (

)和肿瘤学(

LinkedIn

领英

and

X

X

) pages.

`)` 页面。

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Hatanaka K, et al. Discovery of a Novel Orally Available Selective Orexin 2 receptor Agonist, E2086, as a Therapeutic Drug for Narcolepsy and Other Hypersomnia Disorders. Presented at the World Sleep Congress, Rome, Italy, 11-16 March 2022.

长坂和彦等。发现一种新型口服有效的选择性食欲素2受体激动剂E2086,作为治疗嗜睡症和其他嗜睡障碍的药物。于2022年3月11日至16日在意大利罗马举行的世界睡眠大会上发表。

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Eisai Co., Ltd. E2086, A Selective Orexin Receptor-2 Agonist, Promotes Wakefulness in Patients with Narcolepsy Type-1. . Presented at the World Sleep Congress, Singapore, 8 September 2025.

卫材株式会社E2086,一种选择性食欲素受体-2激动剂,在1型嗜睡症患者中促进清醒。于2025年9月8日在新加坡世界睡眠大会上发表。

SOURCE Eisai Inc.

来源:卫材公司

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