灵北制药将在2026年内分泌学会（ENDO）上公布其神经内分泌和神经免疫学项目的最新患者数据-动脉网

Lundbeck to present new patient data on neuroendocrine and neuroimmunology programs at ENDO 2026

CISION 等信源发布 2026-06-10 14:22



可切换为仅中文







Upcoming presentations at ENDO 2026 highlight Lundbeck's Focused Innovator strategy and continued expansion into rare neuroendocrine diseases with high unmet medical needs

ENDO 2026 即将举行的演讲将突出灵北制药的“专注创新者”战略，并展示其在具有高未满足医疗需求的罕见神经内分泌疾病领域的持续扩张。

The scientific program showcases Lundbeck's investigational neurohormonal and neuroimmunological targeted therapeutic candidates, asedebart and Lu AG22515, respectively

科学计划展示了灵北制药在研的神经激素和神经免疫靶向治疗候选药物asedebart和Lu AG22515。

Preliminary Phase II data for asedebart, an investigational anti-adrenocorticotropic hormone (ACTH) monoclonal antibody in Cushing's disease (CD), demonstrate Lundbeck's biomarker-supported approach to evaluating novel therapeutic mechanisms in rare endocrine disorders

用于库欣病（CD）的在研抗促肾上腺皮质激素（ACTH）单克隆抗体asedebart的初步II期临床数据，证明了灵北制药采用生物标志物支持的方法来评估罕见内分泌疾病中的新型治疗机制

Preclinical characterization of the CD40L blocker Lu AG22515 will be shared as well as data from a patient study in thyroid eye disease (TED,) reflecting exploratory studies of CD40L modulation in autoimmune disease biology, with potential relevance to neuroinflammation implicated in several neurological and endocrine diseases.

将分享CD40L阻断剂Lu AG22515的临床前特征描述，以及一项甲状腺眼病（TED）患者研究的数据，这些内容反映了在自身免疫疾病生物学中对CD40L调控的探索性研究，并与多种神经和内分泌疾病中涉及的神经炎症具有潜在相关性。

VALBY, Denmark

丹麦，瓦尔比

，

June 10, 2026

2026年6月10日

/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced that new data will be presented at the 2026 Endocrine Society's Annual Meeting (ENDO), taking place June 13–16 in Chicago, Illinois, U.S. Lundbeck will present preliminary Phase II data for asedebart (Lu AG13909) in CD, reflecting Lundbeck's expansion into neuroendocrine diseases.

/美通社/ -- H. Lundbeck A/S（Lundbeck）今日宣布，将在2026年6月13日至16日于美国伊利诺伊州芝加哥举行的内分泌学会年会（ENDO）上公布新数据。Lundbeck将展示asedebart（Lu AG13909）治疗库欣病（CD）的初步II期临床数据，这体现了Lundbeck向神经内分泌疾病领域的拓展。

In addition, preclinical and Phase Ib clinical exploratory findings on Lu AG22515 in patients with TED will be shared, providing insights into the broader therapeutic potential of CD40L pathway modulation across inflammatory and immunological disorders..

此外，还将分享Lu AG22515在甲状腺眼病（TED）患者中的临床前研究和Ib期临床探索性研究结果，从而为CD40L通路调节在炎症性和免疫性疾病中的更广泛治疗潜力提供见解。

'Lundbeck's presence at ENDO 2026 reflects how we have expanded upon our neuroscience heritage in recent years. This involves pursuing biological drug targets within hormonal and immunological signaling pathways that offer the potential to deliver highly differentiated therapeutics for neurological and neuroendocrinology indications with high medical unmet need,' said Johan Luthman, EVP and Head of Research & Development at Lundbeck.

“灵北制药出席2026年内分泌学会年会（ENDO 2026），体现了我们近年来在神经科学传统基础上的拓展。这包括致力于探索激素和免疫信号通路中的生物药物靶点，以期针对存在高度未满足医疗需求的神经病学及神经内分泌学适应症，提供具有高度差异化的治疗药物。”灵北制药执行副总裁兼研发负责人约翰·卢特曼表示。

'Through this approach, we have made significant progress across our rare disease programs, enabling decisive, biomarker-supported patient studies that facilitate early development decisions, as exemplified by our ENDO 2026 scientific program.'.

“通过这一方法，我们在罕见病项目上取得了显著进展，能够开展由生物标志物支持的决定性患者研究，从而促进早期开发决策，正如我们 ENDO 2026 科学计划所 exemplified 的那样。”

Asedebart data provide insight into ACTH neutralization in Cushing's disease

Asedebart 数据揭示了库欣病中 ACTH 中和作用的机制

Among the highlights are preliminary Phase II data for asedebart, an investigational anti-adrenocorticotropic hormone (ACTH) monoclonal antibody, being evaluated in adults with CD.

亮点包括在研抗促肾上腺皮质激素（ACTH）单克隆抗体asedebart的初步II期数据，该药正在库欣病（CD）成人患者中进行评估。

CD is a rare neuroendocrine disorder typically caused by an ACTH-secreting pituitary adenoma, leading to chronic excess cortisol production and substantial physical and neuropsychiatric burden.

库欣病是一种罕见的神经内分泌疾病，通常由分泌促肾上腺皮质激素（ACTH）的垂体腺瘤引起，导致皮质醇慢性过量产生，并造成严重的身体和神经精神负担。

1,2

While surgery is the standard first-line treatment, many patients experience persistent or recurrent disease despite available pharmacologic options, and significant unmet need remains.

尽管手术是标准的一线治疗方案，但许多患者即便有可用的药物治疗选择，仍会经历持续性或复发性疾病，因此仍存在巨大的未满足医疗需求。

The Phase II data being presented include impact on urinary free cortisol (UFC) levels following individualized dose titration of asedebart, alongside safety and tolerability assessments, supporting further understanding of direct ACTH neutralization in CD.

本次公布的II期临床试验数据包括在个体化剂量滴定asedebart后对尿游离皮质醇（UFC）水平的影响，以及安全性和耐受性评估结果，有助于进一步理解直接中和ACTH在治疗库欣病（CD）中的作用。

The CD study builds on earlier Phase I findings in classic congenital adrenal hyperplasia (CAH) (ClinicalTrials.gov:

该CD研究建立在先前关于经典先天性肾上腺皮质增生症（CAH）的I期研究结果之上（ClinicalTrials.gov：

NCT05669950

), which showed pharmacodynamic effects on key adrenal steroid biomarkers. The CD data presented at ENDO add to Lundbeck's evaluation of targeting ACTH-driven endocrine conditions with links to brain function — using early clinical and pharmacodynamic evidence to assess therapeutic potential in areas of significant unmet need..

），显示出对关键肾上腺类固醇生物标志物的药效学作用。在ENDO会议上展示的CD数据补充了Lundbeck公司针对与脑功能相关的ACTH驱动内分泌疾病的靶向评估——利用早期临床和药效学证据来评估在存在重大未满足需求领域中的治疗潜力。

Asedebart has received Orphan Drug Designation (ODD) for CAH in the European Union and the United States as well as ODD in Japan for the treatment of patients with CD and CAH.

Asedebart 已获得欧盟和美国针对先天性肾上腺皮质增生症（CAH）的孤儿药资格认定（ODD），以及日本针对克罗恩病（CD）和先天性肾上腺皮质增生症（CAH）患者治疗的孤儿药资格认定。

Lu AG22515 data provide insight into CD40L pathway biology

Lu AG22515 数据揭示了 CD40L 通路生物学机制

At ENDO, Lundbeck will also present preclinical characterization findings for the investigational CD40L blocker Lu AG22515. CD40L is a key immune signaling molecule heavily implicated in a wide range of immune disorders, neurology and potentially endocrine conditions.

在ENDO会议上，灵北还将公布在研CD40L阻断剂Lu AG22515的临床前特征研究结果。CD40L是一种关键的免疫信号分子，与多种免疫性疾病、神经系统疾病以及潜在的内分泌疾病密切相关。

The presentation will describe the inhibitory effect and PK/PD profile of Lu AG22515, including effects on membrane-bound and soluble CD40L, B-cell activation and differentiation, proinflammatory cytokine production and in vivo antibody responses.

本报告将介绍 Lu AG22515 的抑制作用及其药代动力学/药效学（PK/PD）特征，包括其对膜结合型和可溶性 CD40L、B 细胞活化与分化、促炎细胞因子产生以及体内抗体反应的影响。

Additionally, clinical findings will be presented from an exploratory Phase Ib open label study on AG22515 in TED patients. TED is an autoimmune disorder that can cause proptosis, diplopia, pain, disfigurement and, in severe cases, visual impairment or vision loss.

此外，还将展示在甲状腺眼病（TED）患者中开展的AG22515探索性Ib期开放标签研究的临床结果。TED是一种自身免疫性疾病，可导致眼球突出、复视、疼痛、面容毁损，严重时还可引起视力障碍或失明。

The presentation will cover three areas: pharmacodynamic assessments designed to evaluate CD40L pathway engagement, safety and tolerability, and preliminary clinical efficacy in TED, including effects on proptosis and other measures of disease activity. The data further enhance the understanding of CD40L pathway modulation in TED and other CD40L-mediated immune disorders..

本次报告将涵盖三个领域：旨在评估CD40L通路参与情况的药效学评价、安全性和耐受性，以及在甲状腺眼病（TED）中的初步临床疗效（包括对突眼及其他疾病活动度指标的影响）。这些数据进一步加深了对CD40L通路调节在TED及其他CD40L介导的免疫性疾病中作用的理解。

Asedebart and Lu AG22515 are investigational drugs not approved for marketing by any regulatory authority worldwide, and the efficacy and safety of both molecules have not been established.

Asedebart 和 Lu AG22515 是研究性药物，尚未获得全球任何监管机构的上市批准，且这两种分子的有效性和安全性尚未确立。

Details of Lundbeck presentations at ENDO 2026

灵北制药在2026年内分泌学会年会（ENDO 2026）上的演讲详情

Therapeutic Area

治疗领域

Presentation content

演示内容

Presentation Type

演示类型

Reference

参考文献

Cushing's disease

库欣病

Asedebart

阿塞德巴特

Lu AG13909

A Phase II, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Novel Anti-ACTH Antibody Asedebart in Adults with Cushing's Disease

一项II期、开放标签、剂量滴定试验，旨在评估新型抗ACTH抗体Asedebart在库欣病成人患者中的安全性、耐受性、药代动力学和疗效

Oral presentation

口头报告

Sun 14 June

6月14日，星期日

14:45-15:00 CT

14:45-15:00 中部时间

Room W183BC

W183BC房间

Thyroid eye disease (TED)

甲状腺眼病（TED）

Lu AG22515

Results From a Phase 1b Trial Evaluating CD40-Ligand Blocker Lu AG22515 in Patients with Moderate-to-Severe Thyroid Eye Disease

一项评估CD40配体阻滞剂Lu AG22515在中重度甲状腺眼病患者中的Ib期临床试验结果

Oral presentation

口头报告

Mon 15 June

6月15日，星期一

14:15-14:30 CT

14:15-14:30 中部时间

W184ABC

Thyroid eye disease (TED)

甲状腺眼病（TED）

Lu AG22515

Preclinical Pharmacokinetic and Pharmacodynamic Profile of Lu AG22515, a CD40-Ligand Blocker in Development for Thyroid Eye Disease

Lu AG22515（一种用于甲状腺眼病开发的CD40配体阻断剂）的临床前药代动力学和药效学特征

Rapid-fire presentation and poster

快速演讲与海报展示

Sun 14 June

6月14日，星期日

09:00- 16:00 CT

09:00 - 16:00 中部时间

ENDOExpo;

ENDOExpo；

Poster floor

海报区

About Cushing's disease

关于库欣病

Cushing's disease is a rare neuro-endocrine disorder caused by a pituitary adenoma that secretes excess ACTH, leading to chronic overproduction of cortisol.

库欣病是一种罕见的神经内分泌疾病，由分泌过量促肾上腺皮质激素（ACTH）的垂体腺瘤引起，导致皮质醇慢性过度产生。

The condition is associated with significant morbidity and increased mortality, and patients may experience a wide range of physical and neuropsychiatric symptoms.

该疾病与显著的发病率和增加的死亡率相关，患者可能出现广泛的躯体及神经精神症状。

First-line treatment is surgical removal of the tumor; however, not all patients are eligible, achieve sustained remission, or benefit fully from current available treatment options, highlighting an ongoing unmet need for effective and well-tolerated therapies.

一线治疗是手术切除肿瘤；然而，并非所有患者都符合手术条件，或能实现持续缓解，或从当前可用的治疗方案中充分获益，这凸显出对有效且耐受性良好的治疗方案的持续未满足需求。

About asedebart (Lu AG13909)

关于 asedebart（Lu AG13909）

Asedebart is a humanized anti-ACTH monoclonal antibody designed specifically to recognize ACTH with high affinity. It blocks the binding of ACTH to the melanocortin 2 receptor in the adrenal glands and thereby inhibits the neurohormonal signalling of ACTH. This inhibition causes a decreased secretion of glucocorticoids, mineralocorticoids and androgens from the adrenal glands.

Asedebart 是一种人源化抗促肾上腺皮质激素（ACTH）单克隆抗体，专为高亲和力识别 ACTH 而设计。它阻断 ACTH 与肾上腺中黑素皮质素 2 受体的结合，从而抑制 ACTH 的神经激素信号传导。这种抑制作用导致肾上腺分泌的糖皮质激素、盐皮质激素和雄激素减少。

。

5,6

ACTH plays a key role in the biosynthesis of adrenal steroids

ACTH在肾上腺类固醇的生物合成中起着关键作用

and is therefore considered a promising therapeutic target in conditions characterized by elevated ACTH levels.

因此被认为是在以促肾上腺皮质激素（ACTH）水平升高为特征的疾病中具有前景的治疗靶点。

About thyroid eye disease (TED)

关于甲状腺眼病（TED）

Thyroid eye disease (TED) is a rare autoimmune condition associated with thyroid dysfunction, characterized by inflammation and expansion of retro-orbital tissues. Clinical manifestations include proptosis, double-vision, pain, swelling, and disfigurement, and in severe cases may lead to visual impairment or loss of vision.

甲状腺眼病（TED）是一种罕见的与甲状腺功能异常相关的自身免疫性疾病，其特征是眶后组织的炎症和增生。临床表现包括眼球突出、复视、疼痛、肿胀和面容毁损，严重情况下可能导致视力障碍或失明。

TED can have a substantial impact on daily functioning, quality of life and psychological wellbeing..

TED 对日常功能、生活质量和心理健康可能产生重大影响。

Current treatments are not optimal for all patients and may be associated with significant adverse effects, highlighting the need for additional therapeutic approaches that target underlying autoimmune disease biology.

当前的治疗方案并非对所有患者都理想，且可能伴随显著的不良反应，这凸显出需要开发针对自身免疫性疾病基础生物学的额外治疗方法。

About Lu AG22515

关于 Lu AG22515

Lu AG22515 is an investigational CD40L blocker being evaluated in CD40L mediated autoimmune diseases. Lu AG22515 is a recombinant fusion protein that binds CD40 ligand (CD40L) and human serum albumin (HSA) to extend half-life. By blocking the interaction between CD40L and the CD40 receptor, Lu AG22515 is designed to modulate a key immune co-stimulatory pathway involved in B-cell activation, antibody responses and inflammatory signaling..

Lu AG22515 是一种正在 CD40L 介导的自身免疫性疾病中进行评估的在研 CD40L 阻滞剂。Lu AG22515 是一种重组融合蛋白，可结合 CD40 配体（CD40L）和人血清白蛋白（HSA），以延长其半衰期。通过阻断 CD40L 与 CD40 受体之间的相互作用，Lu AG22515 旨在调节参与 B 细胞活化、抗体反应和炎症信号传导的关键免疫共刺激通路。

Contacts

联系人

Anders Crillesen

安德斯·克里勒森

Senior Director, External & Internal Relations

对外与对内关系高级总监

[email protected]

+45 27 79 12 86

Jens Høyer

延斯·霍耶

Vice President, Head of Investor Relations

副总裁，投资者关系主管

[email protected]

+45 30 83 45 01

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.

灵北制药是一家专注于脑部健康的生物制药公司。凭借在神经科学领域70余年的经验，我们致力于改善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.

脑部疾病影响着全球很大一部分人口，其影响波及整个社会。随着我们对大脑生物学的理解迅速加深，我们肩负着通过好奇地探索新的治疗机会来促进大脑健康的责任。

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企业，我们致力于通过研发项目应对一些最复杂的神经系统挑战。我们开发变革性药物，面向那些几乎没有或完全缺乏治疗选择的患者群体，并在精神病学和神经学领域深厚积淀的基础上，拓展至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.

我们致力于消除污名化，并采取行动改善健康公平。我们通过为患者、其家庭以及整个社会作出积极贡献，努力为股东创造长期价值。

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site

灵北制药在20多个国家拥有5,000多名员工，我们的产品销往80多个国家。如需更多信息，欢迎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：

Lacroix A, Feelders RA, Stratakis CA, et al. Lancet. 2015;386(9996):913–927

Lacroix A，Feelders RA，Stratakis CA，等。《柳叶刀》。2015；386(9996):913–927

Sharma ST, Nieman LK, Feelders RA. Pituitary. 2015;18(2):188–194

夏尔马 ST，尼曼 LK，费尔德斯 RA。《垂体》。2015；18(2):188–194