Axsome Therapeutics在SLEEP 2025上通过AXS-12和Solriamfetol的多项展示体现了其在睡眠医学领域的创新-动脉网

Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025

Axsome Therapeutics 等信源发布 2025-06-11 19:36

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NEW YORK

纽约

，

June 11, 2025

2025年6月11日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Axsome Therapeutics, Inc.

(NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, .

(NASDAQ: AXSM)是一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司，今日宣布将在2025年6月8日至11日于西雅图举行的第39届睡眠专业学会联合会（APSS）年度会议SLEEP 2025上，进行七场报告，其中包括两场关于AXS-12和solriamfetol的特色口头全体会议。

Washington

华盛顿

。

Details for the presentations are as follows:

演示的详细信息如下：

AXS-12

Title

标题

: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy

ENCODE：AXS-12在嗜睡症的第三阶段开放标签扩展和随机撤药试验的顶线结果

Lead Author:

主要作者：

Richard Bogan

理查德·博根

, MD, FCCP, FAASM, Associate Clinical Professor at the

医学博士，FCCP，FAASM，副教授

University of South Carolina School of Medicine

南卡罗来纳大学医学院

在

Columbia, SC

南卡罗来纳州哥伦比亚市

Poster Presentation Date and Time:

海报展示日期和时间：

Wednesday, June 11, 10 - 11:45 a.m. PT

6月11日星期三，上午10点至11点45分（太平洋时间）

Poster Session:

海报展示环节：

P-51

Poster Number:

海报编号：

405

Title:

标题：

Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial

AXS-12对嗜睡症症状严重程度和功能损害的影响：来自3期SYMPHONY试验的结果

Lead Author:

主要作者：

Michael Thorpy

迈克尔·索普

, MD, Director of the Sleep-Wake Disorders Center at the

，医学博士，睡眠-觉醒障碍中心主任

Montefiore Medical Center

蒙特菲奥里医疗中心

and Professor of Neurology at

神经学教授

Albert Einstein College of Medicine

阿尔伯特·爱因斯坦医学院

，

New York, NY

纽约，纽约州

Oral Presentation Date and Time:

口头报告日期和时间：

Wednesday, June 11

6月11日，星期三

，

3:45 - 4 p.m. PT

下午3点45分 - 4点（太平洋时间）

Oral Session

口头报告环节

：

O-24

Poster Presentation Date and Time:

海报展示日期和时间：

Wednesday, June 11, 10 - 11:45 a.m. PT

6月11日星期三，上午10点至11点45分（太平洋时间）

Poster Session:

海报展示环节：

P-51

Poster Number:

海报编号：

390

Title:

标题：

Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the

治疗满意的嗜睡症患者中的残留症状负担：来自

CRESCENDO Survey

CRESCENDO 调查

Lead Author:

主要作者：

Michael Thorpy

迈克尔·索普

, MD, Director of the Sleep-Wake Disorders Center at the

医学博士，睡眠-觉醒障碍中心主任

Montefiore Medical Center

蒙特菲奥里医疗中心

and Professor of Neurology at

神经病学教授 tại

Albert Einstein College of Medicine

阿尔伯特·爱因斯坦医学院

，

New York, NY

纽约，纽约州

Oral Presentation Date and Time:

口头报告日期和时间：

Wednesday, June 11

6月11日，星期三

，

4 - 4:15 p.m. PT

下午4点至4点15分（太平洋时间）

Oral Session

口头报告会议

：

O-24

Poster Presentation Date and Time:

海报展示日期和时间：

Wednesday, June 11, 10 - 11:45 a.m. PT

6月11日星期三，上午10点至11点45分（太平洋时间）

Poster Session:

海报展示环节：

P-51

Poster Number:

海报编号：

391

Solriamfetol

索利安非托尔

Title

标题

: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study

：索利氨非特对阻塞性睡眠呼吸暂停患者神经心理结果的影响——真实世界SURWEY研究

Lead Author:

主要作者：

Yaroslav Winter

雅罗斯拉夫·温特

, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany

德国美因茨约翰内斯·古腾堡大学神经内科，美因茨综合癫痫与睡眠医学中心

Poster Presentation Date and Time:

海报展示日期和时间：

Wednesday, June 11, 10 - 11:45 a.m. PT

6月11日星期三，上午10点至11点45分（太平洋时间）

Poster Session:

海报展示环节：

P-50

Poster Number:

海报编号：

366

Title

标题

: Real-World Use of Solriamfetol for Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnea in the US

美国阻塞性睡眠呼吸暂停患者使用索利安非托治疗日间过度嗜睡的真实世界应用

Lead Author:

主要作者：

Yang Zhao

杨昭

, PhD,

，博士，

Axsome Therapeutics

Poster Presentation Date and Time:

海报展示日期和时间：

Wednesday, June 11, 10 - 11:45 a.m. PT

6月11日星期三，上午10点至11点45分（太平洋时间）

Poster Session:

海报展示环节：

P-50

Poster Number:

海报编号：

369

About AXS-12

关于AXS-12

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition.

AXS-12（瑞波西汀）是一种高选择性和强效的去甲肾上腺素再摄取抑制剂，以及皮质多巴胺调节剂，正在开发用于治疗嗜睡症。AXS-12被认为可以调节去甲肾上腺素能活动，以在清醒期间保持张力，并通过去甲肾上腺素和皮质多巴胺信号促进清醒和增强认知功能。

AXS-12 has been granted .

AXS-12 已被授予。

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA.

AXS-12 已获得治疗嗜睡症的 FDA 孤儿药资格认定。AXS-12 受已颁发的专利保护，至少到 2039 年。AXS-12 是一种研究性药物，尚未获得 FDA 批准。

About Solriamfetol

关于Solriamfetol

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT

Solriamfetol 是一种多巴胺和去甲肾上腺素再摄取抑制剂 (DNRI)、TAAR1 激动剂和 5-HT

agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

激动剂正在开发用于治疗注意力缺陷多动障碍（ADHD）、重度抑郁症（MDD）、暴食症（BED）以及与轮班工作障碍（SWD）相关的过度嗜睡。

About

关于

Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

Axsome Therapeutics是一家引领中枢神经系统（CNS）疾病治疗新时代的生物制药公司。我们通过识别护理中的关键缺口，开发具有新颖作用机制的差异化产品，从而推动科学突破，为患者带来有意义的治疗进步。

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the .

我们的行业领先的神经科学产品组合包括FDA批准的用于重度抑郁症、与嗜睡症和阻塞性睡眠呼吸暂停相关的过度日间嗜睡以及偏头痛的治疗方法，并且有多个后期开发项目，针对影响超过1.5亿人的广泛严重神经和精神疾病。

United States

美国

. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at

。我们共同肩负着解决大脑一些最重大问题的使命，让患者及其亲人能够茁壮成长。欲了解更多信息，请访问我们的网站

www.axsome.com

and follow us on

并关注我们

领英

and

和

。

Forward Looking Statements

前瞻性声明

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

本新闻稿中讨论的某些事项属于“前瞻性陈述”。公司在某些情况下可能会使用“预测”、“相信”、“潜在”、“继续”、“估计”、“预期”、“计划”、“打算”、“可能”、“能够”、“也许”、“将”、“应该”等词语来传达未来事件或结果的不确定性，以识别这些前瞻性陈述。

In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI.

特别是，公司关于趋势和潜在未来结果的声明属于此类前瞻性陈述的例子。前瞻性声明包含风险和不确定性，包括但不限于公司SUNOSI的商业成功。

, AUVELITY

，AUVELITY

, and SYMBRAVO

，以及SYMBRAVO

products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain .

产品以及公司为solriamfetol和/或AXS-05获得任何额外适应症的努力的成功；公司维持和扩大支付方覆盖的能力；公司正在进行的临床试验及预计进行的临床试验的成功、时间安排和成本，包括关于试验启动时间、入组速度和完成情况的声明（包括公司完全资助其已披露临床试验的能力，这假设公司目前预测的收入或支出没有重大变化），无效性分析及中期结果的接收，这些结果不一定表明公司正在进行的临床试验的最终结果，和/或数据读出，以及支持公司当前任何候选产品的新药申请（“NDA”）所需的研究数量或类型或结果性质；公司为继续推进其候选产品而资助额外临床试验的能力；公司获得并维持的时间和能力。

U.S. Food and Drug Administration

美国食品药品监督管理局

(“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control.

（“FDA”）或其他监管机构对公司产品候选物的批准或其他相关行动，包括任何NDA提交时间的声明；公司成功捍卫其知识产权或以公司可接受的成本获得必要许可的能力（如果可能的话）；公司成功解决任何知识产权诉讼的能力，即使这些争议得以解决，相关联邦机构是否批准此类和解；公司研发项目和合作的成功实施；公司许可协议的成功；市场对公司产品及其候选产品的接受程度（如获批准）；公司预期的资本需求，包括用于SUNOSI、AUVELITY和SYMBRAVO商业化以及公司其他产品候选物商业化（如获批准）所需的资本金额，及其对公司预期现金跑道的潜在影响；公司将销售额转化为确认收入并保持有利的销售净额比例的能力；由于国内政治气候、地缘政治冲突或全球疫情及其他因素引起的不可预见情况或对正常业务运营的其他干扰，包括一般经济状况和不受公司控制的监管发展。

The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking sta.

本文讨论的因素可能导致实际结果和发展与这些陈述所表达或暗示的有重大差异。前瞻性陈述仅在本新闻稿发布之日作出，公司不承担公开更新此类前瞻性陈述的义务。

Investors:

投资者：

Mark Jacobson

马克·雅各布森

Chief Operating Officer

首席运营官

(212) 332-3243

mjacobson@axsome.com

Media:

媒体：

Darren Opland