Neuron23 Announces $96.5 Million Series D Financing and First Patient Dosed in Global Phase 2 NEULARK Clinical Trial of NEU-411 for Early Parkinson’s Disease

Neuron23宣布完成9650万美元D轮融资，并在全球二期NEULARK临床试验中对早期帕金森病药物NEU-411进行首例患者给药

NEULARK trial to evaluate NEU-411, a brain-penetrant, potent and selective LRRK2 inhibitor, in people with LRRK2-driven Parkinson’s disease; topline data anticipated in 2027

NEULARK 试验评估 NEU-411（一种可穿透大脑、强效且选择性的 LRRK2 抑制剂）在 LRRK2 驱动的帕金森病患者中的效果；预计 2027 年获得初步数据。

SOUTH SAN FRANCISCO, Calif., June 24, 2025-- Neuron23® Inc., a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, today announced the closing of a $96.5 million Series D financing round led by a healthcare investor, with significant support from existing investors Westlake Village BioPartners, SoftBank Vision Fund 2, Redmile Group, Blue Owl, Kleiner Perkins, HBM Healthcare Investments (Cayman) Ltd., and Acorn Bioventures.

南旧金山，加利福尼亚州，2025年6月24日——Neuron23®公司是一家临床阶段的生物技术公司，专注于为基因定义的神经系统和免疫系统疾病开发精准药物，今天宣布完成了由一家医疗保健投资者领投的9650万美元D轮融资，现有投资者西湖村生物伙伴（Westlake Village BioPartners）、软银愿景基金2号（SoftBank Vision Fund 2）、红岭集团（Redmile Group）、蓝猫头鹰（Blue Owl）、克莱纳·珀金斯（Kleiner Perkins）、HBM医疗投资（开曼）有限公司以及Acorn Bioventures提供了重要支持。

The Company also announced the first patient has been dosed in the global Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant, potent and selective inhibitor of LRRK2, in people with early Parkinson’s disease (PD)..

公司还宣布，在早期帕金森病（PD）患者中，全球 Phase 2 NEULARK 临床试验中，第一例患者已经接受了 NEU-411 的给药。NEU-411 是一种能穿透大脑、强效且选择性的 LRRK2 抑制剂。

“The Series D financing represents further endorsement of Neuron23’s industry-leading approach, which leverages state-of-the-art precision medicine and patient identification to deliver NEU-411 to people with Parkinson’s disease who are most likely to benefit from LRRK2 inhibition, increasing probability of success in the clinic and bringing the right therapy to the right patients,” said Nancy Stagliano, Ph.D., Chief Executive Officer of Neuron23..

“D轮融资进一步证明了Neuron23行业领先的方法，该方法利用最先进的精准医疗和患者识别技术，将NEU-411带给最可能从LRRK2抑制中受益的帕金森病患者，提高临床成功的可能性，并为合适的患者提供合适的治疗。” Neuron23首席执行官Nancy Stagliano博士表示。

“The dosing of the first patient in the NEULARK clinical trial marks a pivotal milestone in Parkinson’s disease research. For the first time, we are using a precision medicine approach to identify and enroll patients with LRRK2-driven disease,” said Dr. Aaron Ellenbogen, a movement disorders neurologist, Medical Director at Quest Research Institute, and NEULARK study investigator.

“NEULARK临床试验中首位患者给药标志着帕金森病研究的一个关键里程碑。我们首次采用精准医学方法，识别并招募LRRK2驱动型疾病的患者，”运动障碍神经科医生、Quest研究所医学主任及NEULARK研究调查员Aaron Ellenbogen博士表示。

“This trial’s design, incorporating a unique digital biomarker to frequently monitor disease progression, enables us to capture exceptionally precise, real-time data on both motor and non-motor symptoms, offering unparalleled insights into how the disease evolves. With multiple innovative elements cohesively working together in the NEULARK trial, we’re poised to take a significant step forward in the pursuit of effective treatments for Parkinson’s disease.”.

“该试验的设计引入了一个独特的数字生物标志物，以频繁监测疾病进展，使我们能够获取关于运动和非运动症状极其精确的实时数据，为疾病的演变提供了前所未有的洞察。在NEULARK试验中，多个创新元素协同作用，让我们有望在寻找帕金森病有效治疗方法的道路上迈出重要一步。”

The global Phase 2 NEULARK clinical trial (NCT06680830) is a randomized, double-blind, placebo-controlled study in people with early-stage, LRRK2-driven PD. The study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of orally administered NEU-411. The trial will enroll approximately 150 participants who will receive NEU-411 or placebo daily for a 52-week treatment period.

全球二期NEULARK临床试验（NCT06680830）是一项针对早期LRRK2驱动的帕金森病患者的随机、双盲、安慰剂对照研究。该研究将评估口服NEU-411的疗效、安全性、药代动力学和药效学。试验将招募约150名参与者，他们将在52周的治疗期内每日接受NEU-411或安慰剂。

The trial incorporates a smartphone equipped with proprietary software developed by Roche Information Solutions (RIS) that frequently measures PD symptoms such as movement and tremor, as well as non-motor symptoms such as cognition. The primary endpoint is the change from baseline in the Roche digital biomarker score compared to placebo.

该试验使用了一款配备了由罗氏信息解决方案（RIS）开发的专用软件的智能手机，能够频繁测量帕金森病症状，例如运动和震颤，以及非运动症状如认知功能。主要终点是与安慰剂相比，罗氏数字生物标志物评分从基线的变化。

Secondary outcome measures include the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a widely recognized tool for evaluating Parkinson's symptoms..

次要结局指标包括运动障碍学会的统一帕金森病评定量表 (MDS-UPDRS)，这是一种广泛认可的评估帕金森病症状的工具。

Neuron23 has partnered with Sano Genetics to streamline patient referrals and assist in the identification of people with PD who may be eligible to participate in the NEULARK clinical trial. Under a separate protocol, Sano is offering saliva test kits that can identify people with LRRK2-driven PD. Individuals identified will be referred to the nearest NEULARK clinical trial site for a complete eligibility evaluation and potential enrollment.

Neuron23与Sano Genetics合作，简化患者转诊流程，并帮助识别可能符合参与NEULARK临床试验资格的帕金森病（PD）患者。在另一项协议下，Sano提供唾液检测套装，可以识别由LRRK2驱动的帕金森病患者。被识别出的个体将被转介至最近的NEULARK临床试验地点，进行完整的资格评估和潜在的入组。

More information can be found at https://neulark.com..

更多信息可访问 https://neulark.com 查看。

About LRRK2’s Role in Parkinson’s Disease and NEU-411

关于LRRK2在帕金森病中的作用及NEU-411

Mutations in the LRRK2 gene are among the most common genetic causes of PD, affecting approximately 2% of people with the disease. Individuals who inherit gain-of-function mutations in LRRK2 are at higher risk of developing PD later in life. Importantly, there is a growing body of evidence that LRRK2 activity may play a role in a subset of the larger population of people without a family history of PD, known as idiopathic PD, suggesting that therapies targeting LRRK2 could be beneficial to a broader population than just individuals with rare, familial LRRK2 mutations..

LRRK2基因的突变是帕金森病（PD）最常见的遗传因素之一，大约影响2%的患者。继承LRRK2功能获得性突变的个体在晚年患帕金森病的风险更高。重要的是，越来越多的证据表明，LRRK2的活性可能在一部分没有帕金森病家族史的人群（即特发性帕金森病）中发挥作用，这表明针对LRRK2的治疗可能不仅对少数家族性LRRK2突变患者有益，还可能惠及更广泛的群体。

Neuron23 has identified single-nucleotide polymorphisms (SNPs) – variations in an individual’s DNA sequence – that are predicted to drive LRRK2 overactivity in up to 30% of people with idiopathic PD. People with PD who have these SNPs, together with those who have LRRK2 gene mutations, make up the population collectively referred to as LRRK2-driven PD and represent who Neuron23 believes is most likely to benefit from LRRK2 inhibition..

Neuron23 已经鉴定出单核苷酸多态性 (SNPs)——个体 DNA 序列的变异——这些变异预计会导致高达 30% 的特发性帕金森病 (PD) 患者中 LRRK2 过度活跃。具有这些 SNPs 的帕金森病患者，连同那些携带 LRRK2 基因突变的人，构成了被称为 LRRK2 驱动型帕金森病的群体，Neuron23 认为这些人最有可能从 LRRK2 抑制中受益。

NEU-411 is a potent, highly selective and brain-penetrant oral LRRK2 inhibitor with best-in-class potential. By specifically inhibiting the overactive LRRK2 kinase pathway, NEU-411 aims to address an underlying cause of disease progression in people with LRRK2-driven PD, offering a more precise and potentially more effective approach compared to existing treatment options that only address some symptoms of PD..

NEU-411 是一种高效、高选择性且可穿透大脑的口服LRRK2抑制剂，具有同类最佳的潜力。通过特异性抑制过度活跃的LRRK2激酶通路，NEU-411旨在解决由LRRK2驱动的帕金森病（PD）患者疾病进展的根本原因，相比现有仅缓解部分PD症状的治疗方案，提供了更精准且可能更有效的治疗方法。

About Parkinson’s Disease

关于帕金森病

Parkinson’s disease (PD) is a brain disorder that causes irregular movements, such as shaking, stiffness and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking. Additional symptoms can include mental and behavioral changes, such as sleep problems, depression, memory difficulties and fatigue..

帕金森病（PD）是一种脑部疾病，会导致不规则的运动，例如震颤、僵硬以及平衡和协调困难。症状通常逐渐出现并随着时间的推移而加重。随着疾病的进展，人们可能会出现行走和说话困难。其他症状可能包括心理和行为变化，例如睡眠问题、抑郁、记忆力困难和疲劳。

Some cases of PD appear to be hereditary, and a few cases can be traced to specific genetic mutations. Currently, there is no available cure or therapy that impacts underlying PD progression, and treatment options are only used to alleviate some symptoms.

一些帕金森病病例似乎是遗传性的，少数病例可以追溯到特定的基因突变。目前，尚无可用的治愈方法或能够影响帕金森病进展的疗法，现有的治疗选项仅用于缓解部分症状。

About Neuron23®

关于Neuron23®

Neuron23 Inc. is a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases. Neuron23 combines recent advances in human genetics with a state-of-the-art drug discovery and biomarker platform using advanced techniques in machine learning and artificial intelligence to advance therapeutics for devastating diseases.

Neuron23 Inc. 是一家临床阶段的生物技术公司，专注于开发针对基因定义的神经系统和免疫系统疾病的精准药物。Neuron23 结合了人类遗传学的最新进展与最先进的药物发现和生物标志物平台，利用机器学习和人工智能的先进技术，推动对严重疾病的治疗方案发展。

The Company’s focus areas are neurodegenerative diseases, neuroinflammatory diseases, and systemic autoimmune and inflammatory diseases. Founded in 2018, Neuron23 has assembled a world-class team of experts and entrepreneurs located in South San Francisco, CA. For more information, please visit www.neuron23.com, or follow us on LinkedIn and X (formerly Twitter)..

公司的重点领域是神经退行性疾病、神经炎症性疾病以及系统性自身免疫和炎症性疾病。Neuron23成立于2018年，组建了一支由位于加利福尼亚州南旧金山的专家和企业家组成的世界级团队。欲了解更多信息，请访问www.neuron23.com，或在LinkedIn和X（原Twitter）上关注我们。

Contact:

联系人：

Josie Butler

乔茜·巴特勒

1AB

1AB

josie@1abmedia.com

josie@1abmedia.com