欧洲首位参与者已在AskBio公司针对帕金森病的AB-1005基因疗法二期试验中随机入组-动脉网

First European Participants Randomized in AskBio Phase 2 Gene Therapy Trial of AB-1005 for Parkinson’s Disease

拜耳等信源发布 2025-09-22 18:10

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可切换为仅中文

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September

九月

2025

11:58 AM

上午11点58分

Europe/Amsterdam

欧洲/阿姆斯特丹

First European Participants Randomized in AskBio Phase 2 Gene Therapy Trial of AB-1005 for Parkinson’s Disease

欧洲首位参与者在AskBio二期基因治疗试验中随机分配，测试AB-1005对帕金森病的效果

Summary

摘要

AB-1005, a glial cell line-derived neurotrophic factor (GDNF) investigational gene therapy, is being evaluated for the treatment of moderate-stage Parkinson’s disease in the REGENERATE-PD trial / Sites in Poland and the United Kingdom have started randomizing participants, with sites in Germany actively screening and following shortly / AskBio initiated recruitment in the United States in 2024, with enrollment ongoing.

AB-1005是一种胶质细胞源性神经营养因子（GDNF）研究性基因疗法，正在REGENERATE-PD试验中评估其对中度帕金森病的治疗效果。波兰和英国的试验点已经开始随机分配参与者，德国的试验点正在积极筛选，并将很快跟进。AskBio于2024年在美国启动了患者招募，目前注册正在进行中。

Research Triangle Park, N.C. – September 22, 2025

北卡罗来纳州研究三角园区——2025年9月22日

–

AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the first European participants have been randomized in REGENERATE-PD, a Phase 2 clinical trial in participants with moderate-stage Parkinson’s disease (PD).

AskBio Inc.（AskBio）是一家基因治疗公司，为拜耳集团全资拥有并独立运营的子公司，今天宣布在REGENERATE-PD二期临床试验中，首批欧洲参与者已完成随机分组。该试验针对中度帕金森病（PD）患者。

“I believe the randomization of the first European participants in REGENERATE-PD, which makes this the first neurosurgical gene therapy program for Parkinson’s to successfully randomize patients from both the United States and Europe into a single Phase 2 trial, is positive news for people living with Parkinson’s disease and the physicians treating them,” said Alan Whone, MD, PhD, REGENERATE-PD Europe Lead and Principal Investigator.

“我相信REGENERATE-PD中首批欧洲参与者的随机化是一个积极的消息，这使得该计划成为首个成功将来自美国和欧洲的患者随机分配到单一二期试验中的帕金森病神经外科基因治疗项目，这对帕金森病患者及其治疗医生而言都是利好消息，” REGENERATE-PD欧洲负责人及首席研究员Alan Whone博士表示。

“There is a significant need for neurorestorative therapies in Parkinson’s and seeing the advancement of an important investigational gene therapy in a Phase 2 clinical trial will give hope to patients and the medical community alike.”.

“帕金森病对神经修复疗法有显著需求，看到一项重要的基因治疗在二期临床试验中取得进展，将为患者和医学界带来希望。”

PD is a progressive, neurodegenerative disorder affecting 1.2 million people in Europe, and this number is expected to double by 2030.

帕金森病是一种渐进性神经退行性疾病，影响着欧洲120万人，预计到2030年这一数字将翻倍。

With the worldwide unmet medical need in mind, the objective of REGENERATE-PD, a randomized, double-blind, surgically controlled clinical trial, is to evaluate the safety and efficacy of investigational gene therapy AB-1005 delivered to the putamen in the brain of adult participants aged 45–75 years with moderate-stage PD..

考虑到全球未满足的医疗需求，REGENERATE-PD 的目标是评估研究性基因疗法 AB-1005 在 45 至 75 岁中度帕金森病成人患者中递送至脑部壳核的安全性和有效性。该试验为随机、双盲、手术对照的临床试验。

REGENERATE-PD is estimated to enroll approximately 87 participants across clinical centers in Germany, Poland, the United Kingdom, and the United States.

REGENERATE-PD 预计将在德国、波兰、英国和美国的临床中心招募大约 87 名参与者。

“Today’s announcement marks an important milestone in the clinical development of our investigational gene therapy AB-1005, as we continue to work hard to deliver a safe and effective treatment option that may be neurorestorative for certain populations and may benefit people living with moderate-stage Parkinson’s disease,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer at AskBio. “We are encouraged by the initiation of the REGENERATE-PD program in Europe and look forward to sharing further clinical updates as the program advances over the coming year.”.

“今天的公告标志着我们正处于实验性基因疗法 AB-1005 临床开发的一个重要里程碑。我们将继续努力，为某些人群提供一种可能具有神经修复作用的安全有效的治疗选择，并使中度帕金森病患者受益。” AskBio 的首席开发官兼首席医学官江灿文医学博士说道，“欧洲 REGENERATE-PD 项目的启动让我们备受鼓舞，我们期待在未来一年中随着项目的推进分享更多的临床进展。”

Earlier this year, AB-1005 was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the United States Food and Drug Administration (FDA).

今年早些时候，AB-1005获得了美国食品药品监督管理局（FDA）授予的再生医学先进疗法（RMAT）指定。

RMAT is a designation granted by the FDA to regenerative therapies, including gene therapies, being developed to treat, modify, reverse, or cure serious or life-threatening diseases or conditions.

RMAT是FDA授予再生疗法（包括基因疗法）的指定，这些疗法正在开发用于治疗、改善、逆转或治愈严重或危及生命的疾病或状况。

AB-1005 met the RMAT requirements as a gene therapy that is intended to slow disease progression and improve motor outcomes in patients with PD. RMAT provides recipients with enhanced access to the FDA, which could include intensive guidance on efficient drug development, rolling Biologics License Application (BLA) review, and other actions to expedite review..

AB-1005 作为一项旨在减缓帕金森病（PD）患者疾病进展并改善运动功能的基因疗法，满足了 RMAT 的要求。RMAT 为获授者提供了与 FDA 更高的沟通权限，可能包括针对高效药物开发的深入指导、生物制品许可申请（BLA）的滚动审评以及其他加快审查的措施。

AskBio is also exploring AB-1005 beyond PD, in participants in the United States with the parkinsonian subtype of multiple system atrophy (MSA-P) in a Phase 1 clinical trial to assess the preliminary safety, tolerability, and efficacy for this rapidly progressing condition.

AskBio 还在美国的参与者中进行一项 1 期临床试验，探索 AB-1005 在帕金森型多系统萎缩（MSA-P）患者中的应用，以评估该药物对这种快速进展疾病的安全性、耐受性和有效性。

AB-1005 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.

AB-1005 是一种研究性基因疗法，尚未获得任何监管机构的批准，其有效性和安全性尚未确定或完全评估。

About Parkinson’s disease

关于帕金森病

Parkinson’s disease (PD) is a progressive neurodegenerative disease.

帕金森病 (PD) 是一种进展性神经退行性疾病。

It has a significant impact on a person’s daily life.

它对一个人的日常生活有重大影响。

In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function.

在帕金森病中，大脑中产生多巴胺的神经细胞死亡导致运动功能的持续丧失。

Symptoms include tremors, muscle rigidity, and slowness of movement.

症状包括震颤、肌肉僵硬和运动迟缓。

Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression.

此外，帕金森病患者还会经历非运动症状，包括疲劳、缺乏精力、认知问题和抑郁。

Symptoms typically intensify over time and make everyday tasks demanding.

症状通常会随着时间的推移而加重，使日常任务变得艰巨。

The prevalence of PD has doubled over the past 25 years.

过去25年，PD的患病率翻了一番。

Today, more than 10 million people worldwide are estimated to be living with PD.

今天，全世界估计有超过一千万人患有帕金森病。

This makes it the world’s second most prevalent neurodegenerative disease.

这使得它成为世界上第二常见的神经退行性疾病。

It is also the most frequent movement disorder.

它也是最常见的运动障碍。

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At present there is no cure, and current treatment options are inadequate and lack the holistic management of symptoms so there is an urgent need for new therapies.

目前尚无治愈方法，现有的治疗选择不充分，缺乏对症状的整体管理，因此迫切需要新的治疗方法。

About the AB-1005 Phase 1b trial

关于AB-1005第一阶段b试验

In the AB-1005 Phase 1b, multicenter, open-label, uncontrolled trial, participants were administered AB-1005 to the putamen via one-time bilateral convection-enhanced delivery.

在AB-1005的1b期多中心、开放标签、无对照试验中，参与者通过一次性双侧对流增强递送方式将AB-1005施用于壳核。

Participants were enrolled into two cohorts, mild (6 participants) and moderate (5 participants), based upon the duration and stage of their Parkinson’s disease (PD).

根据帕金森病 (PD) 的持续时间和阶段，参与者被分为两个队列：轻度（6 名参与者）和中度（5 名参与者）。

The objective of this investigation was to evaluate the safety and potential clinical effect of AB-1005 delivered to the putamen in participants with either mild- or moderate-stage PD.

本研究的目的是评估将AB-1005递送至轻度或中度帕金森病（PD）患者的壳核中的安全性和潜在临床效果。

The outcomes assessed at 36 months were incidence of treatment-emergent adverse events (TEAEs) as reported by the participants or assessed clinically by physical and neurological examinations, motor symptoms as reported via the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), and PD Motor Diary self-assessments, non-motor symptoms of PD, and brain dopaminergic network integrity as measured by DaTSCAN..

在36个月时评估的结果包括：由参与者报告或通过体格和神经系统检查临床评估的治疗相关不良事件（TEAEs）的发生率、通过运动障碍学会统一帕金森病评定量表（MDS-UPDRS）报告的运动症状以及PD运动日记的自我评估、帕金森病的非运动症状，以及通过DaTSCAN测量的脑多巴胺能网络完整性。

These assessments will continue for up to five years. For more information, visit clinicaltrials.gov (

这些评估将持续长达五年。欲了解更多信息，请访问 clinicaltrials.gov (

NCT04167540

或

askbio.com

问生物公司网站

）。

About REGENERATE-PD

关于REGENERATE-PD

REGENERATE-PD is a Phase 2, randomized, double-blind, surgery controlled trial of the efficacy and safety of intraputaminal AB-1005 in the treatment of adults (45–75 years) with moderate-stage Parkinson’s disease.

REGENERATE-PD 是一项二期、随机、双盲、手术对照试验，评估了脑内注射AB-1005在治疗中度帕金森病（45-75岁）成人患者中的疗效和安全性。

The trial will include an estimated 87 participants with trial sites located in Germany, Poland, the United Kingdom, and the United States.

试验将包括大约87名参与者，试验地点位于德国、波兰、英国和美国。

For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (

有关 REGENERATE-PD 临床试验的更多信息，请访问 clinicaltrials.gov (

NCT06285643

), or visit

），或者访问

askbio.com

。

About AB-1005

关于 AB-1005

AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery..

AB-1005 是一种基于腺相关病毒载体血清型 2 (AAV2) 的研究性基因疗法，包含人胶质细胞系源性神经营养因子 (GDNF) 转基因，可通过磁共振成像监测的对流增强递送方式进行直接神经外科注射，从而在大脑局部区域实现 GDNF 的稳定和持续表达。

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In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons.

在非临床研究中，GDNF已被证明能够促进多巴胺能神经元的存活和形态分化。

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Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as Parkinson’s disease (PD), marked by progressive degeneration of midbrain dopaminergic neurons.

重组GDNF长期以来一直被评估为治疗诸如帕金森病（PD）等疾病的潜在药物，这些疾病以中脑多巴胺能神经元的进行性退化为特征。

Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, we can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.

通过结合一种研究中的基因疗法和创新的神经外科递送方法，我们现在可以以一种可能更具临床相关性的方式将这种神经营养因子递送到这些正在退化的黑质纹状体神经元，从而在帕金森病中验证GDNF假说。

About AskBio

关于AskBio

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to steering gene therapy into a new era where it can transform the lives of a wider range of people living with rare and more common diseases. The company maintains a portfolio of clinical programs across a range of disease indications related to a single gene or multiple factors across cardiovascular, central nervous system, and neuromuscular conditions, with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease.

AskBio Inc. 是拜耳集团全资拥有并独立运营的子公司，是一家完全集成的基因治疗公司，致力于将基因治疗引入一个新时代，使其能够改变更广泛人群的生活，包括罕见病和更常见疾病的患者。该公司在心血管、中枢神经系统和神经肌肉疾病领域，针对单基因或多因素相关的疾病适应症，拥有多项临床项目组合，其临床阶段的管线包括用于治疗充血性心力衰竭、肢带型肌营养不良、多系统萎缩、帕金森病和庞贝病的在研疗法。

AskBio’s end-to-end gene therapy platform includes our Pro10™ technology, which makes gene therapies more accessible by making research and commercial grade manufacturing more affordable. With global headquarters in Research Triangle Park, North Carolina, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

AskBio的端到端基因治疗平台包括我们的Pro10™技术，该技术通过降低研究和商业级制造成本，使基因治疗更加普及。公司总部位于北卡罗来纳州研究三角园区，在全球范围内已开发出数百种专有的衣壳和启动子，其中一些已进入临床前和临床测试阶段。

An early innovator in the gene therapy field, with over 900 employees in five countries, the company holds more than 600 patents and patent applications in areas such as AAV production and chimeric capsids. Learn more at .

作为基因治疗领域的早期创新者，该公司在五个国家拥有超过900名员工，并在AAV生产和嵌合衣壳等领域持有600多项专利和专利申请。欲了解更多信息，请访问。

http://www.askbio.com/

or follow us on

或关注我们

领英

。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司的产品和服务旨在帮助人类和地球繁荣发展，支持应对不断增长和老龄化的全球人口所带来的重大挑战。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用总计达62亿欧元。欲了解更多信息，请访问。

http://www.bayer.com

。

AskBio Forward-Looking Statements

AskBio前瞻性声明

This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements.

本新闻稿包含“前瞻性陈述”。本新闻稿中包含的任何非事实性陈述的内容均可能被视为前瞻性陈述。诸如“相信”、“预期”、“计划”、“预计”、“将”、“意图”、“潜力”、“可能”等词语及类似表述旨在识别前瞻性陈述。

These forward-looking statements include, without limitation, statements regarding AskBio’s clinical trials. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned clinical and regulatory milestones and timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office.

这些前瞻性声明包括但不限于关于 AskBio 临床试验的声明。这些前瞻性声明涉及许多风险和不确定性，其中许多是 AskBio 无法控制的。已知的风险包括但不限于：AskBio 可能由于多种原因无法执行其商业计划和目标，包括无法达到预期或计划的临床和监管里程碑及时间表、对第三方的依赖、临床开发计划、制造流程与计划，以及将其产品候选物推向市场的能力。这些原因可能包括公司财务及其他资源的潜在限制、可能未被及时预见或解决的制造限制、与第三方合作者和合作伙伴之间可能出现的分歧或其他问题，以及来自监管机构、法院或相关机构的反馈或决定，例如来自美国食品药品监督管理局或美国专利商标局的反馈和决定。

Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof..

上述任何风险都可能对AskBio的业务和经营结果产生重大不利影响。您不应过分依赖本新闻稿中包含的前瞻性陈述。AskBio不承担基于此后发生的事件或情况公开更新其前瞻性陈述的义务。

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参考文献

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1. 欧洲帕金森病协会。让我们来谈谈帕金森病。可用资源：

https://www.age-platform.eu/sites/default/files/EPDA-Political_Manifesto_Parkinson.pdf

. Accessed: August 2025.

访问日期：2025年8月。

2. ClinicalTrials.gov. A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD). Available at:

2. ClinicalTrials.gov. 一项关于AAV2-GDNF在中度帕金森病成人中的研究 (REGENERATE-PD)。可在以下网址获取：

https://clinicaltrials.gov/study/NCT06285643

. Accessed: August 2025.

访问日期：2025年8月。

3. AskBio. AskBio Receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease investigational gene therapy. Available at:

3. AskBio。AskBio获得FDA再生医学先进疗法认定，用于帕金森病的在研基因疗法。可在以下网址获取：

https://www.askbio.com/askbio-receives-fda-regenerative-medicine-advanced-therapy-designation-for-parkinsons-disease-investigational-gene-therapy/

https://www.askbio.com/askbio获得FDA再生医学高级疗法指定用于帕金森病调查基因治疗/

. Accessed: August 2025.

访问日期：2025年8月。

4. Food and Drug Administration. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. Available at:

4. 食品药品监督管理局。严重疾病再生医学疗法的快速审批程序。可在：

https://www.fda.gov/media/120267/download

. Accessed: August 2025.

访问日期：2025年8月。

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5. ClinicalTrials.gov。GDNF基因疗法用于多系统萎缩。可见于：

https://clinicaltrials.gov/study/NCT04680065

. Accessed: August 2025.

访问日期：2025年8月。

6. World Health Organization. Parkinson Disease. Available at:

6. 世界卫生组织。帕金森病。可访问：

https://www.who.int/news-room/fact-sheets/detail/parkinson-disease

https://www.who.int/zh/news-room/fact-sheets/detail/parkinson-disease

. Accessed August 2025.

. 2025年8月访问。

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