Neurocrine Biosciences宣布启动Osavamator的3期注册计划，作为治疗成人重度抑郁症的辅助疗法-动脉网

Neurocrine Biosciences Announces Initiation of Phase 3 Registrational Program for Osavampator as an Adjunctive Therapy for the Treatment of Major Depressive Disorder in Adults

CISION 等信源发布 2025-01-28 21:30

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SAN DIEGO

圣地亚哥

Jan. 28, 2025

2025年1月28日

/PRNewswire/ --

/美通社/ --

Neurocrine Biosciences, Inc.

Neurocrine Biosciences公司。

(Nasdaq:

（纳斯达克：

NBIX

) today announced the initiation of a Phase 3 registrational study to evaluate the efficacy, safety and tolerability of osavampator (formerly NBI-1065845), an investigational drug under development as an adjunctive treatment to antidepressants for major depressive disorder (MDD). Positive topline data for the Phase 2 SAVITRI™ study of osavampator in adult subjects with MDD were announced in .

)今天宣布开始进行一项3期注册研究，以评估osavampator（以前称为NBI-1065845）的疗效，安全性和耐受性，osavampator是一种正在开发的研究药物，用于辅助治疗重度抑郁症（MDD）的抗抑郁药。年宣布了成人MDD受试者osavampator的SAVITRI™2期研究的阳性topline数据。

April 2024

2024年4月

'Osavampator has the potential to become a first-in-class treatment for MDD, a disorder that impacts more than 21 million people in

“Osavampator有可能成为MDD的一流治疗方法，MDD是一种影响2100多万人的疾病

the United States

美国

,' said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. 'More than a third of those MDD sufferers endure debilitating symptoms that current treatment options cannot fully resolve.'

Neurocrine Biosciences首席医学官EiryW.Roberts医学博士说超过三分之一的MDD患者出现了目前的治疗方案无法完全解决的衰弱症状。”

The

Phase 2 SAVITRI study

第二阶段SAVITRI研究

with osavampator met its primary and secondary endpoints, and was generally well tolerated.

使用osavampator达到了其主要和次要终点，并且通常耐受性良好。

'Major depressive disorder is a condition that has a profound effect on patients and their families and is associated with significant morbidity and mortality,' said

他说：“重度抑郁症是一种对患者及其家人产生深远影响的疾病，与严重的发病率和死亡率有关。”

Maurizio Fava

毛里齐奥·法瓦

, M.D., Chair, Mass General Brigham Academic Medical Centers Department of Psychiatry. 'The great majority of patients suffering from major depressive disorder do not achieve a sustained remission of their condition and the options for next step strategies to help them are quite limited. This trial is happening at a time when it is clear that, as a field, we need to develop new augmentation strategies to enhance the efficacy of standard antidepressants.'.

，医学博士，马萨诸塞州布莱根将军学术医学中心精神病学系主任。”绝大多数患有重性抑郁症的患者并没有实现病情的持续缓解，下一步帮助他们的策略的选择非常有限。这项试验发生的时候，很明显，作为一个领域，我们需要开发新的增强策略来提高标准抗抑郁药的疗效。”。

About

关于

Osavampator and the Phase 3 Registrational Program

Osavampator和第三阶段注册计划

Osavampator (formerly NBI-1065845) is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with inadequate response to treatment in MDD. Neurocrine received an exclusive license to osavampator from Takeda Pharmaceutical Company Limited for all indications in all territories worldwide except .

Osavampator（原名NBI-1065845）是一种潜在的一流研究性α-氨基-3-羟基-5-甲基-4-异恶唑丙酸（AMPA）阳性变构调节剂（PAM），正在开发中，作为对MDD治疗反应不足的患者的潜在治疗方法。Neurocrine从武田制药有限公司获得了osavampator在全球所有地区的所有适应症的独家许可，除了。

Japan

日本

The Phase 3 registrational program is designed to assess the efficacy, safety and tolerability of osavampator in adult subjects with MDD. The study will enroll adults with a primary diagnosis of MDD, who have inadequate response to current antidepressant treatment. For more information about the Phase 3 osavampator study, click .

第三阶段注册计划旨在评估osavampator在MDD成年受试者中的疗效，安全性和耐受性。该研究将招募主要诊断为MDD的成年人，他们对目前的抗抑郁药治疗反应不足。有关第3阶段osavampator研究的更多信息，请单击。

here

在这里

About Major Depressive Disorder

关于重度抑郁症

Major depressive disorder (MDD) is a serious disorder characterized by a persistently depressed mood, loss of interest, poor concentration, and decreased energy, among other symptoms. According to the World Health Organization, MDD is one of the leading causes of disability, is a serious condition that presents an increased risk of suicide and self-harm, and is associated with increased all-cause mortality rates. More than 21 million people in the U.S.

重度抑郁症（MDD）是一种严重的疾病，其特征是情绪持续抑郁，兴趣丧失，注意力不集中，能量下降等症状。据世界卫生组织称，MDD是导致残疾的主要原因之一，是一种严重的疾病，会增加自杀和自我伤害的风险，并与全因死亡率增加有关。美国有2100多万人。

live with MDD and it is estimated that roughly a third of those do not respond to available antidepressants..

患有MDD，据估计，大约三分之一的患者对现有的抗抑郁药没有反应。。

About Neurocrine Biosciences

关于神经分泌生物科学

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.

Neurocrine Biosciences是一家领先的以神经科学为重点的生物制药公司，其目的很简单：为有巨大需求的人减轻痛苦。我们致力于为神经、神经内分泌和神经精神疾病患者发现和开发改变生活的治疗方法。

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

该公司多元化的产品组合包括FDA批准的治疗迟发性运动障碍、与亨廷顿舞蹈病相关的舞蹈病、经典先天性肾上腺增生、子宫内膜异位症*和子宫肌瘤*的药物，以及一条强大的管道，其中包括我们核心治疗领域中晚期临床开发中的多种化合物。

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit .

三十年来，我们将自己独特的见解应用于神经科学以及大脑和身体系统之间的相互联系，以治疗复杂疾病。我们坚持不懈地寻求药物来减轻使人衰弱的疾病和紊乱的负担，因为你值得勇敢的科学。有关更多信息，请访问。

neurocrine.com

, and follow the company on

，并跟踪公司

X (formerly Twitter)

X（前推特）

, and

，以及

Facebook

脸书

in collaboration with AbbVie)

与AbbVie合作）

The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SAVITRI is a trademark of Neurocrine Biosciences, Inc.

NEUROCRINE BIOSCIENCES徽标Lockup and YOU Worth BRAVE SCIENCE是NEUROCRINE BIOSCIENCES，Inc.的注册商标。SAVITRI是NEUROCRINE BIOSCIENCES，Inc.的商标。

Forward-Looking Statements

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the safety, efficacy, and therapeutic potential of NBI-1065845; and the results, conduct, and timing of our NBI-1065845 Phase 3 clinical study.

除历史事实外，本新闻稿还包含前瞻性陈述，涉及许多风险和不确定性。这些声明包括但不限于关于NBI-1065845的安全性，有效性和治疗潜力的声明；以及我们的NBI-1065845 3期临床研究的结果，行为和时间。

Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S.

可能导致实际结果与前瞻性声明中所述或暗示的结果存在重大差异的因素包括但不限于以下因素：临床开发活动可能无法按时或根本无法启动或完成，或可能因监管，制造或其他原因而延迟，可能无法成功或复制以前的临床试验结果，可能无法证明我们的候选产品安全有效，或者可能无法预测现实世界的结果或后续临床试验的结果；可能不会发生或无法及时提交针对我们候选产品的监管提交文件的风险；我们未来的财务和经营业绩；与我们依赖第三方进行产品和候选产品的开发、制造和商业化活动有关的风险，以及我们管理这些第三方的能力；FDA或其他监管机构可能对我们的产品或候选产品做出不利决定的风险；与我们的合作伙伴达成协议的潜在利益可能永远无法实现的风险；我们的产品和/或我们的候选产品可能因第三方的专有权或监管权而无法商业化，或产生意外副作用、不良反应或误用事件的风险；与美国相关的风险。

federal or state legisla.

联邦或州法律。

September 30, 2024

2024年9月30日

. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

.Neurocrine Biosciences不承担任何义务在本新闻稿发布日期后更新本新闻稿中包含的声明，法律要求的除外。

SOURCE Neurocrine Biosciences, Inc.

来源Neurocrine Biosciences，Inc。

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