Neurocrine Biosciences宣布启动评估第二代VMAT2抑制剂NBI-1140675在健康成人中的1期临床研究-动脉网

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults

CISION 等信源发布 2025-03-05 21:30

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SAN DIEGO

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March 5, 2025

2025年3月5日

/PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq:

/PRNewswire/ -- Neurocrine Biosciences, Inc.（纳斯达克：

NBIX

) today announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of investigational compound NBI-1140675 in healthy adult participants. NBI-1140675 is an investigational, oral, selective second-generation small molecule inhibitor of the vesicular monoamine transporter 2 (VMAT2) in development for the potential treatment of certain neurological and neuropsychiatric conditions.

）今天宣布启动一项一期临床研究，以评估在健康成年参与者中试验化合物NBI-1140675的安全性、耐受性、药代动力学和药效学。NBI-1140675是一种在研的口服选择性第二代小分子囊泡单胺转运体2（VMAT2）抑制剂，正在开发用于某些神经和神经精神疾病的潜在治疗。

。

'We are focused on extending our bench of VMAT2 inhibitors in development, building on our successful discovery and development of valbenazine for the treatment of tardive dyskinesia and chorea in Huntington's disease,' said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. 'NBI-1140675 is an internally discovered, highly potent, selective VMAT2 inhibitor with the potential to provide differentiated benefit in treating certain neurological and neuropsychiatric conditions.'.

“我们专注于扩展我们正在开发的VMAT2抑制剂产品线，基于我们在发现和开发valbenazine用于治疗迟发性运动障碍和亨廷顿病相关的舞蹈症方面取得的成功，”Neurocrine Biosciences首席医学官Eiry W. Roberts博士说道。“NBI-1140675是一种内部发现的高效、选择性VMAT2抑制剂，有潜力在治疗某些神经和神经精神疾病方面提供差异化的益处。”

NBI-1140675 joins NBI-1065890 as a second-generation VMAT2 inhibitor undergoing evaluation by Neurocrine in Phase 1 clinical studies. VMAT2 inhibitors have been clinically validated as effective treatments for hyperkinetic movement disorders, playing an important role in presynaptic dopamine storage and release.

NBI-1140675与NBI-1065890一起作为第二代VMAT2抑制剂，正在由Neurocrine进行一期临床研究评估。VMAT2抑制剂已被临床验证为治疗过度运动障碍的有效方法，在突触前多巴胺储存和释放中发挥重要作用。

Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease.

2017年，Neurocrine成功开发并获得美国食品药品监督管理局批准，将选择性VMAT2抑制剂缬苯那嗪作为首个治疗迟发性运动障碍的药物。2023年，该公司获得FDA批准，将缬苯那嗪用于治疗与亨廷顿病相关的舞蹈症。

Valbenazine is in Phase 3 clinical studies as an adjunctive treatment with antipsychotics for schizophrenia and as a treatment for dyskinetic cerebral palsy..

Valbenazine正在进行第三阶段临床研究，作为抗精神病药物的辅助治疗用于精神分裂症，以及用于治疗运动障碍型脑瘫。

About Neurocrine Biosciences

关于Neurocrine Biosciences

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是一家领先的神经科学-focused生物制药公司，拥有一个简单的宗旨：减轻高需求患者的痛苦。我们致力于为神经、神经内分泌和神经精神疾病治疗不足的患者发现和开发生命改变的治疗方法。

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.

公司多样化的产品组合包括FDA批准的治疗药物，适应症涵盖迟发性运动障碍、亨廷顿病相关的舞蹈症、经典先天性肾上腺增生、子宫内膜异位症*和子宫肌瘤*，同时还有强大的研发管线，包含多个处于中期至晚期临床开发阶段的化合物，覆盖我们的核心治疗领域。

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，我们运用对神经科学以及大脑和身体系统之间相互联系的独特见解来治疗复杂疾病。我们不懈追求药物研发，以减轻衰弱性疾病和病症带来的负担，因为您值得拥有勇敢的科学。欲了解更多信息，请访问。

neurocrine.com

, and follow the company on

，关注公司

领英

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, and

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Facebook

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in collaboration with AbbVie)

与艾伯维合作）

NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.

神经内分泌、神经内分泌生物科学标志和你值得勇敢的科学是神经内分泌生物科学公司的注册商标。

Forward-Looking Statements

前瞻性声明

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 efficacy and therapeutic potential of NBI-1140675. Factors 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.

除历史事实外，本新闻稿还包含涉及若干风险和不确定性的前瞻性陈述。这些陈述包括但不限于关于 NBI-1140675 的有效性和治疗潜力的陈述。可能导致实际结果与前瞻性陈述中所述或暗示的结果有重大差异的因素包括但不限于以下：临床开发活动可能无法按时启动或完成，或者由于监管、生产或其他原因可能被延迟，可能无法成功或复制之前的临床试验结果，可能无法证明我们的候选产品安全有效，或者可能无法预测真实世界的结果或后续临床试验中的结果；我们候选产品的监管提交可能不会发生或无法及时提交；我们未来的财务和运营表现；与我们依赖第三方进行产品的开发、生产和商业化活动以及我们管理这些第三方的能力相关的风险；FDA 或其他监管机构可能对我们产品或候选产品做出不利决定的风险；与合作合作伙伴签订的协议的潜在利益可能永远无法实现的风险；我们的产品和/或候选产品可能因第三方的专利或监管权利而被排除在商业化之外，或存在意外的副作用、不良反应或误用事件的风险；与美国相关的风险。

federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse i.

联邦或州的立法、监管和/或政策努力，可能导致不利影响，其中包括但不限于。

December 31, 2024

2024年12月31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否认有任何义务在本新闻稿发布日期之后更新其中包含的声明，除非法律要求。

SOURCE Neurocrine Biosciences, Inc.

来源：Neurocrine Biosciences, Inc.

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