Spinogenix宣布其评估SPG302作为阿尔茨海默病首创新型突触再生疗法的二期试验已全面入组-动脉网

Spinogenix Announces Full Enrollment in its Phase 2 Trial Evaluating SPG302 as a First-in-Class Synaptic Regenerative Therapy for Alzheimer's Disease

CISION 等信源发布 2025-06-24 20:30

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First Cohort Results to be Presented at AAIC in

首批队列结果将在AAIC上公布

Toronto

多伦多

, July 2025

，2025年7月

FDA Clears IND in Alzheimer's Disease, Enabling Future Expansion to U.S.

FDA批准阿尔茨海默病IND，为未来拓展至美国铺平道路

LOS ANGELES

洛杉矶

，

June 24, 2025

2025年6月24日

/PRNewswire/ --

Spinogenix, Inc.

斯皮诺吉尼克斯公司

, a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced full enrollment of its Phase 2 clinical trial in

，一家临床阶段的生物制药公司，率先开发一流疗法以恢复突触功能，改善全球患者的生活，今天宣布其二期临床试验的全面入组。

Australia

澳大利亚

evaluating SPG302 for the treatment of people with Alzheimer's disease (AD). SPG302 is a once-daily pill with the potential to regenerate synapses and reverse cognitive decline in people with mild to moderate AD.

评估SPG302治疗阿尔茨海默病（AD）患者的潜力。SPG302是一种每日一次的药丸，有可能再生突触并逆转轻度至中度AD患者的认知衰退。

Spinogenix is completing a randomized, double-blind, placebo-controlled Phase 2 study of SPG302 (

Spinogenix 正在完成一项随机、双盲、安慰剂对照的 SPG302 二期研究 (

NCT06427668)

NCT06427668

to assess the safety, tolerability, and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. Two dose cohorts are being evaluated in a total of 24 participants. The first cohort has completed 24 weeks of treatment (inclusive of a double-blind phase and an open label extension period).

评估SPG302在患有轻至中度阿尔茨海默病（AD）的成年参与者中的安全性、耐受性和临床疗效。总共有24名参与者被分为两个剂量组进行评估。第一个队列已完成为期24周的治疗（包括双盲阶段和开放标签延长期）。

Results from this cohort will be presented at the Alzheimer's Association International Conference (AAIC) in .

该队列的结果将在阿尔茨海默病协会国际会议（AAIC）上公布。

Toronto

多伦多

打开

July 27-31, 2025

2025年7月27日至31日

。

In parallel, the U.S. Food and Drug Administration (FDA) cleared Spinogenix's Investigational New Drug (IND) application for SPG302 for the treatment of people with AD.

同时，美国食品药品监督管理局（FDA）批准了Spinogenix公司用于治疗阿尔茨海默病（AD）患者的SPG302的研究性新药（IND）申请。

'Full enrollment in our first AD clinical trial marks a significant step in our mission to bring SPG302 to patients and their loved ones suffering from this debilitating condition, and we are eager to share the encouraging results from our first patient cohort at AAIC,' said Dr.

“我们首次阿尔茨海默病临床试验的全面入组标志着我们在将SPG302带给遭受这种衰弱病症困扰的患者及其亲人这一使命中迈出了重要的一步，我们渴望在AAIC上分享我们第一批患者队列的鼓舞人心的结果，”博士说道。

Stella Sarraf

斯特拉·萨拉夫

, Spinogenix CEO and Founder. 'The FDA's vote of confidence in SPG302 as a candidate treatment for AD – and the opportunity to evaluate this innovative therapy in the U.S. – represents the next step forward for Spinogenix, as we work to provide hope to the more than 55 million people worldwide battling AD, and pursue our mission in leaving no patients behind on the journey to find new treatment options.'.

Spinogenix首席执行官兼创始人表示：“FDA对SPG302作为AD候选治疗药物的信任投票——以及在美国评估这种创新疗法的机会——代表了Spinogenix向前迈出的下一步，我们致力于为全球超过5500万名正在与AD抗争的患者带来希望，并在寻找新治疗方案的旅程中践行不落下任何患者的使命。”

AD is the most common cause of dementia, accounting for 60-70% of cases worldwide. Loss of synapses occurs very early in AD and is a major driver of cognitive and memory decline.

阿尔茨海默病是最常见的痴呆症原因，占全球病例的60-70%。突触丧失在阿尔茨海默病早期就会发生，是认知和记忆能力下降的主要驱动因素。

SPG302 offers the first synaptic regenerative approach to treating AD with the potential to improve cognition and quality of life. As such, SPG302 represents a potential new class of regenerative medicine therapeutics that can be used in combination with standard of care cholinesterase inhibitors, as well as recently approved antibody therapies targeting amyloid beta..

SPG302 提供了首个针对阿尔茨海默病（AD）的突触再生治疗方法，有潜力改善认知功能和生活质量。因此，SPG302 代表了一类潜在的新型再生医学疗法，可与标准护理胆碱酯酶抑制剂以及最近获批的靶向β淀粉样蛋白的抗体疗法联合使用。

'We have long understood that synapse regeneration could be the key to improving cognition and quality of life in people with Alzheimer's,' said Dr.

“我们早就了解到，突触再生可能是改善阿尔茨海默病患者认知能力和生活质量的关键，”博士说道。

Bruce Brew

布鲁斯·布鲁

, MD, DSc, FRACP, FAAN, neurologist and Principal Investigator at St. Vincent's Hospital in

，医学博士，理学博士，澳大利亚皇家内科医学院院士，美国神经病学学会会员，圣文森特医院神经科医生兼首席研究员

Sydney, Australia

悉尼，澳大利亚

. 'Current therapies may slow disease progression, but they come with significant side effects and offer little improvement in cognitive function. SPG302 is the first therapy that may soon realize the promise of synapse regeneration, opening an entirely new avenue for treatment. The early trial results are promising, and FDA clearance of this IND opens the door for expansion of trials in the U.S., marking an important step forward in the journey to transform how we manage AD.'.

“当前的治疗方法可能会减缓疾病进展，但它们伴随着显著的副作用，并且在认知功能方面几乎没有改善。SPG302 是首个可能很快实现突触再生的疗法，开辟了治疗的全新途径。早期试验结果令人鼓舞，FDA 批准该 IND 为在美国扩大试验铺平了道路，这标志着我们在改变 AD 管理方式的旅程中迈出了重要的一步。”

'I am thrilled by the latest milestone achieved by the Spinogenix team in advancing SPG302 in Alzheimer's disease, and look forward to U.S. patients having the opportunity to participate in important and groundbreaking clinical trials,' added

“Spinogenix团队在阿尔茨海默病的SPG302研究中取得的最新里程碑让我感到非常兴奋，我期待美国患者有机会参与重要且具有突破性的临床试验，”他补充道。

Jerre Stead

杰里·斯蒂德

, Chairman of Banner Alzheimer's Institute, Chairman of Stead Impact Ventures, and member of the Spinogenix Board of Directors.

，班纳阿尔茨海默病研究所主席、斯特德影响力创投公司主席，以及 Spinogenix 董事会成员。

About SPG302

关于SPG302

SPG302 is a once-a-day pill being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases with the unique ability to restore synapses, the key connections between neurons that allow people to think, plan, remember, and control movement. The synaptic regenerative activity of SPG302 represents a first-in-class approach to treating these diseases and has the potential to reverse declines in cognitive, respiratory, and motor function.

SPG302 是一种每日一次的药丸，正在被开发为一种针对神经退行性疾病和神经精神疾病的再生治疗药物，具有独特的能力来恢复突触——神经元之间允许人们思考、计划、记忆和控制运动的关键连接。SPG302 的突触再生活性代表了一种首创的治疗方法，有可能逆转认知、呼吸和运动功能的衰退。

SPG302 is being evaluated as an investigational therapeutic in three disease indications: Alzheimer's disease (.

SPG302 正在作为研究性治疗药物在三种疾病适应症中进行评估：阿尔茨海默病（。

NCT06427668)

, ALS (

，ALS（

NCT05882695

) and Schizophrenia (

）和精神分裂症（

NCT06442462

About Spinogenix

关于Spinogenix

Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction – offering patients and their families a new reality of hope..

目前，针对神经退行性、神经精神类和神经发育性疾病的治疗主要集中在减缓疾病进展或减轻症状上，这让许多患者对改善病情感到无望。Spinogenix 旨在通过其首创的、具有范式转变意义的突触再生与突触矫正疗法来改变这些疾病的治疗现状，这些疗法旨在恢复耗竭的突触，逆转突触退化和功能障碍，为患者及其家庭带来充满希望的新前景。

Spinogenix is developing two novel therapeutics: SPG302, which triggers neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and SPG601, which works at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms.

Spinogenix正在开发两种新型疗法：SPG302，可触发神经元生成新的谷氨酸能突触，并在ALS、阿尔茨海默病、精神分裂症等疾病中恢复认知、运动及其他功能；以及SPG601，它在突触水平上作用，以纠正脆性X综合征（FXS）中导致许多核心症状的特定功能障碍。

The company has received FDA and EMA Orphan Drug designations for ALS as well as FDA Orphan Drug and Fast Track designations for FXS. More information on Spinogenix can be found at .

该公司已获得FDA和EMA关于ALS的孤儿药资格认定，以及FDA关于FXS的孤儿药和快速通道资格认定。更多关于Spinogenix的信息可以在以下网站找到：。

www.spinogenix.com

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