灵北将在波士顿举行的国际多系统萎缩症大会上分享罕见病多系统萎缩症的管线数据及关键见解-动脉网

Lundbeck to share pipeline data and key insights into the progression of rare disease, Multiple System Atrophy, at International MSA Congress in Boston

CISION 等信源发布 2025-05-08 14:33



可切换为仅中文







VALBY,

瓦尔比，

Denmark

丹麦

，

May 8, 2025

2025年5月8日

/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present key pipeline data and patient perspectives from the phase II AMULET trial, investigating amlenetug as a potential new treatment option targeting the rare neurological disorder, multiple system atrophy (MSA), in tandem with recent natural history data, shedding light on early disease progression of the condition..

/PRNewswire/ -- H. Lundbeck A/S（Lundbeck）将公布关键的管线数据及来自二期AMULET试验的患者视角，该试验研究amlenetug作为针对罕见神经系统疾病多系统萎缩症（MSA）的潜在新治疗选择，并结合近期的自然史数据，揭示该疾病的早期进展。

Lundbeck today announced that pipeline data will be presented at the 2025 International MSA Congress in

Lundbeck今天宣布，将在2025年国际MSA大会上展示其研发管线数据。

Boston

波士顿

, U.S., May 9-11. The data includes results from the AMULET phase II trial, coupled with patient perspectives from the trial, and new insights from the MSA natural history study, TALISMAN.

，美国，5月9-11日。数据包括AMULET二期试验的结果，结合了试验中的患者观点，以及MSA自然史研究TALISMAN的新见解。

Studying disease progression and survival is essential to understand the natural history of MSA, however currently there is limited data available.

研究疾病进展和生存情况对于理解MSA的自然史至关重要，但目前可获得的数据有限。

The TALISMAN study will help to better understand how the disease develops over time, particularly in the early MSA population, and support phase III drug development.

TALISMAN研究将有助于更好地理解这种疾病随着时间的推移如何发展，特别是在早期MSA人群中，并支持III期药物开发。

MSA is a debilitating disease with a poor prognosis and a significant unmet medical need, however relatively little is known about its progression and natural history, particularly at the early stage. Patient level data like this is important for understanding not only the patients we seek to help, but is critical to guiding our R&D efforts as we move into Phase III trials.

MSA是一种令人衰弱的疾病，预后较差且存在显著未满足的医疗需求，但对其病程和自然史知之甚少，尤其是在早期阶段。此类患者层面的数据不仅对于理解我们试图帮助的患者非常重要，而且对我们进入III期临床试验时指导研发工作也至关重要。

We look forward to engaging with the MSA community in May and discussing the impact of this data on future horizons in MSA management,.

我们期待在五月份与MSA社区互动，并讨论这些数据对未来MSA管理视野的影响。

said

说

Johan Luthman

约翰·卢特曼

, EVP and Head of Research & Development at Lundbeck.

，伦贝克公司执行副总裁兼研发部门负责人。

The data comes as Lundbeck is gearing up for the Phase III trial, MASCOT, involving the investigational treatment, amlenetug, a monoclonal antibody targeting α-synuclein for the potential treatment of MSA. MSA is a rare, rapidly progressing neurodegenerative disease, for which there are currently no approved therapies..

数据公布之际，灵北制药正准备启动涉及研究性治疗药物amlenetug的III期试验MASCOT，这是一种靶向α-突触核蛋白的单克隆抗体，有可能用于治疗MSA。MSA是一种罕见的、进展迅速的神经退行性疾病，目前尚无获批的治疗方法。

Lundbeck will also be presenting insights from patients who participated in the completed phase II trial (AMULET).

Lundbeck 还将介绍参与已完成的 II 期试验 (AMULET) 的患者的见解。

These insights highlight the burden of the disease, both for people living with MSA, and also on their care partners. The perspectives from these patient exit-interviews have informed the design of the phase III MASCOT trial, demonstrating Lundbeck's continued commitment to elevating the patients' voice in the R&D process, and optimizing clinical trial design around patient needs..

这些见解突显了该疾病对 MSA 患者及其护理伙伴的负担。这些患者退出访谈所提供的视角为 III 期 MASCOT 试验的设计提供了信息，展示了 Lundbeck 对在研发过程中提升患者声音的持续承诺，以及围绕患者需求优化临床试验设计。

Details of Lundbeck poster presentations at MSA 2025:

2025年MSA大会上Lundbeck海报展示的详细信息：

Poster 8: Incorporating patient and care partner feedback on the protocol for a clinical trial assessing progression in MSA

海报8：在评估MSA进展的临床试验方案中纳入患者和护理伙伴的反馈

Presenter:

主持人：

Beatrice Yang

杨碧翠丝

, Lundbeck

，伦贝克

Date and location:

日期和地点：

May 10

5月10日

, 12:00 –13:00 at Porter Square

，12:00 –13:00 在波特广场

Also accepted as oral presentation:

也接受作为口头报告：

May 9

5月9日

, at 13:35 at Amesbury AB

，13时35分于埃姆斯伯里AB

Poster 10: The natural history of multiple system atrophy: a prospective Chinese cohort study

海报10：多系统萎缩的自然病史：一项前瞻性中国人群队列研究

Presenter: Aroussi Bidani, Lundbeck

主持人：Aroussi Bidani，Lundbeck公司

Date and location:

日期和地点：

May 9

5月9日

, 11:45 –13:00 at Porter Square

，11:45 –13:00 在波特广场

Poster 13: Amlenetug for the treatment of patients with MSA: A randomized, controlled phase 2 trial

海报13：Amlenetug治疗MSA患者的随机对照2期试验

Presenter:

主持人：

Wolfgang Singer

沃尔夫冈·辛格

, Mayo Clinic Rochester

梅奥诊所罗切斯特分部

Date and location:

日期和地点：

May 10

5月10日

, 12:00 –13:00 at Porter Square

，12:00 –13:00 在波特广场

Also accepted as oral presentation:

也被接受为口头报告：

May 9

5月9日

at 9:55 at Amesbury CD

9点55分在阿姆斯伯里CD

About amlenetug

关于 amlenetug

Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein and thereby intended to prevent uptake and inhibit seeding of aggregation.

Amlenetug 是一种人源单克隆抗体（mAb），能够识别并结合所有主要形式的细胞外 α-突触核蛋白，从而旨在防止其摄取并抑制聚集的种子形成。

Amlenetug is being developed by Lundbeck under a joint research and licensing agreement between Lundbeck and Genmab A/S. Amlenetug is an investigational compound that is not approved for marketing by any regulatory authority worldwide.

Amlenetug正在由Lundbeck与Genmab A/S之间的联合研究和许可协议下开发。Amlenetug是一种研究性化合物，尚未获得全球任何监管机构的上市批准。

About the AMULET trial

关于AMULET试验

AMULET trial (NCT05104476) was a phase II, randomized, double-blind, placebo-controlled clinical trial of amlenetug as a potential treatment for patients with MSA. MSA patients were randomized 2:1 to either amlenetug or placebo and treated between 48 to 72 weeks, followed by an ongoing 96 weeks open-label extension period offering all participants to receive treatment with amlenetug..

AMULET试验（NCT05104476）是一项二期、随机、双盲、安慰剂对照的临床试验，研究amlenetug作为多系统萎缩（MSA）患者的潜在治疗药物。MSA患者以2:1的比例随机分配至amlenetug组或安慰剂组，并接受48至72周的治疗，随后进入一个为期96周的开放标签延长期，所有参与者在此阶段均接受amlenetug治疗。

The primary objective was to evaluate the efficacy of amlenetug on clinical progression in patients with MSA, aiming at showing a slowing in clinical progression in the active treatment arm compared to placebo on a 5% significance level evaluated 1-sided as well as safety and tolerability. The secondary objectives included evaluation of amlenetug on patient's functioning, disease severity and other aspects of MSA.

主要目标是评估amlenetug对MSA患者临床进展的疗效，旨在显示与安慰剂相比，活性治疗组在5%显著性水平上单侧评估时临床进展有所减缓，并评估其安全性和耐受性。次要目标包括评估amlenetug对患者功能、疾病严重程度及MSA其他方面的效果。

Amlenetug was delivered as an intravenous infusion every four weeks. .

Amlenetug 每四周通过静脉输注给药。

About the MASCOT trial

关于MASCOT试验

MASCOT (NCT06706622) is a phase III, interventional, randomized, double-blind, parallel-group, placebo-controlled, optional open-label extension trial that will be conducted in

MASCOT（NCT06706622）是一项III期、干预性、随机、双盲、平行组、安慰剂对照、可选开放标签扩展试验，将在以下地区开展：

North America

北美

，

Europe

欧洲

，

Asia

亚洲

and

和

Australia

澳大利亚

。

The trial comprises 2 parts: A double-blind period where participants are randomized to receive either high or low doses of amlenetug, or placebo for 72 weeks, followed by an open-label extension period where all participants enrolled in the trial are offered treatment with amlenetug.

试验包括两部分：一部分是双盲阶段，参与者被随机分配接受高剂量或低剂量的阿米内图，或安慰剂，持续72周；随后是一个开放标签延长期，在此期间所有参与试验的人都会被提供阿米内图治疗。

The aim of the trial is to evaluate the efficacy, safety, and tolerability of amlenetug in patients with MSA. Amlenetug will be delivered as an intravenous infusion every four weeks.

该试验的目的是评估阿米奈珠单抗在MSA患者中的疗效、安全性和耐受性。阿米奈珠单抗将每四周通过静脉输注给药。

Contacts

联系人

Marie Petterson

玛丽·佩特森

Head of Media Relations, Corp. Communication

媒体关系主管，企业传播部

MEEP@lundbeck.com

+45 29 82 21 82

Jens Høyer

延斯·霍伊尔

Vice President, Head of Investor Relations

副总裁，投资者关系主管

JSHR@lundbeck.com

+45 30 83 45 01

Palle Holm Olesen

帕勒·霍尔姆·奥勒森

Vice President, Investor Relations

投资者关系副总裁

PALO@lundbeck.com

帕罗@灵北.com

+45 30 83 24 26

About H. Lundbeck A/S

关于H. Lundbeck A/S

Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

灵北是一家专注于脑健康的生物制药公司。凭借在神经科学领域超过70年的经验，我们致力于改善患有神经和精神疾病患者的生活。

Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

脑部疾病影响着世界上很大一部分人口，其影响贯穿整个社会。随着对大脑生物学的迅速深入了解，我们通过积极探索治疗的新机会，致力于推动脑健康的发展。

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology..

作为一家专注的创新者，我们努力使我们的研发项目应对一些最复杂的神经学挑战。我们开发变革性药物，针对那些治疗选择很少或没有的人群，从我们在精神病学和神经学领域的坚实基础上，扩展到神经专科和神经罕见病领域。

We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

我们致力于消除歧视，并采取行动改善健康公平。我们努力为股东创造长期价值，同时为患者、他们的家人以及整个社会做出积极贡献。

Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site

灵北在超过50个国家拥有约5700名员工，我们的产品在全球80多个国家有售。欲了解更多信息，我们鼓励您访问我们的企业网站。

www.lundbeck.com

and connect with us via

并通过以下方式与我们联系

领英

。

References:

参考文献：

1. Foubert-Samier A,

et al

等

. Neurobiol Dis. 2020:139:104813

神经生物疾病。2020年；139：104813

2. Åström DO,

2. 奥斯特伦 DO，

et al

等人

. Poster Presentation. International MSA Congress 2025

海报展示。2025年国际MSA大会

3. Liu M,

3. 刘 M，

et al

等

. J Neurol. 2024:14;271(5):2324–2344

《神经病学杂志》，2024年，第271卷，第5期，2324-2344页

4. Yang B,

4. 杨 B，

et al

等

. Poster Presentation. International MSA Congress 2025

海报展示。2025年国际MSA大会

5. Kjærsgaard L,

5. 克耶尔高 L，

et al

等

. Poster Presentation. International MSA Congress 2025

海报展示。2025年国际MSA大会

CONTACT:

联系人：

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby,

奥蒂莉亚街9号，邮编2500，瓦尔比，

Denmark

丹麦

+45 3630 1311

info@lundbeck.com

This information was brought to you by Cision

此信息由Cision提供给您。

http://news.cision.com

。

https://news.cision.com/h--lundbeck-a-s/r/lundbeck-to-share-pipeline-data-and-key-insights-into-the-progression-of-rare-disease--multiple-syst,c4145960

https://news.cision.com/h--lundbeck-a-s/r/灵北将分享罕见病-多系统萎缩症的管线数据及关键见解,c4145960

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/18215/4145960/3431515.pdf

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