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展示灵北制药的“专注创新者”战略,以及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拓展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的临床前特征数据,以及一项甲状腺眼病(TED)患者研究的数据,这些数据反映了在自身免疫疾病生物学中对CD40L调节的探索性研究,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)上公布最新数据。Lundbeck将展示asedebart(Lu AG13909)治疗库欣病(CD)的初步II期临床试验数据,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. “Lundbeck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。这包括探索激素和免疫信号通路中的生物药物靶点,这些靶点有望为存在高度未满足医疗需求的神经病学和神经内分泌学适应症提供具有显著差异化的治疗药物。” Lundbeck执行副总裁兼研发负责人Johan Luthman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,开展了由生物标志物支持的关键性患者研究,从而助力早期开发决策,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 的中和作用Among the highlights are preliminary Phase II data for asedebart, an investigational anti-adrenocorticotropic hormone (ACTH) monoclonal antibody, being evaluated in adults with CD. 亮点包括在库欣病(CD)成人患者中评估的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。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,导致皮质醇长期过量产生,并造成严重的身体和神经精神负担。1,2 1,2While 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法,但许多患者尽管有可用的药物治疗选择,仍会经历持续或复发的疾病,因此仍存在巨大的未满足需求。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. 所呈现的II期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,有助于进一步理解直接中和ACTH在库欣病(CD)中的作用。The CD study builds on earlier Phase I findings in classic congenital adrenal hyperplasia (CAH) (ClinicalTrials.gov: CD 研究基于此前在经典先天性肾上腺皮质增生症(CAH)中开展的 I 期研究结果(ClinicalTrials.gov:NCT05669950 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.. ),该研究显示了对关键肾上腺类固醇生物标志物的药效学作用。在ENDO会议上公布的CD数据补充了灵北制药对靶向与脑功能相关的ACTH驱动性内分泌疾病的评估——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(ODD)。Lu AG22515 data provide insight into CD40L pathway biology Lu AG22515 数据提供了对 CD40L 通路生物学的深入见解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,灵北制药还将展示研究性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。3 3The presentation will describe the inhibitory effect and PK/PD profile ofLu AG22515, including effects on membrane-bound and soluble CD40L, B-cell activation and differentiation, proinflammatory cytokine production and in vivo antibody responses. 本次报告将阐述 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,还将展示一项在甲状腺眼病(TED)患者中开展的关于AG22515的探索性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、容貌损毁,以及在严重情况下出现视力障碍或失明。4 4The 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 Lu AG13909A 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、药代动力学和疗效的II期、开放标签、剂量滴定试验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室Thyroid eye disease (TED) 甲状腺眼病(TED)Lu AG22515 Lu AG22515Results 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配体阻断剂Lu AG22515在中重度甲状腺眼病患者中的1b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 W184ABCThyroid eye disease (TED) 甲状腺眼病(TED)Lu AG22515 Lu AG22515Preclinical 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 快速报告与海报展示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。1 1The condition is associated with significant morbidity and increased mortality, and patients may experience a wide range of physical and neuropsychiatric symptoms. 该病症与显著的发病率和增加的死亡率相关,患者可能会出现各种身体和神经精神症状。2 2First-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,并非所有患者都适合手术、能获得持续缓解或从当前可用的治疗方案中充分受益,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。Aboutasedebart (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 5,6ACTH 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关键作用7 7and is therefore considered a promising therapeutic target in conditions characterized by elevated ACTH levels. 因此,它被认为是在以ACTH水平升高为特征的疾病中一个有前景的治疗靶点。6 6About 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紊乱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,严重病例可能导致视力受损或失明。TED can have a substantial impact on daily functioning, quality of life and psychological wellbeing.. TED可能对日常功能、生活质量和心理健康产生重大影响。4 4Current 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. 目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。4 4About Lu AG22515 关于 Lu AG22515Lu 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[emailprotected] [emailprotected]+45 27 79 12 86 +45 27 79 12 86JensHøyer 延斯·霍耶Vice President, Head of Investor Relations 副总裁兼投资者关系主管[emailprotected] [email protected]+45 30 83 45 01 +45 30 83 45 01About H. Lundbeck A/S 关于 H. Lundbeck A/SLundbeck 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逾70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大量人口,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。我们通过对患者、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 灵北制药在全球20多个国家拥有5,000多名员工,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 www.lundbeck.comand connect with us via 并通过以下方式联系我们LinkedIn 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):913–927Sharma ST,Nieman LK, Feelders RA. Pituitary. 2015;18(2):188–194 Sharma ST, Nieman LK, Feelders RA. 《垂体》. 2015;18(2):188–194Ots HD, Tracz JA, Vinokuroff KE, et al. Int J Mol Sci. 2022;23(8):4115 Ots HD,Tracz JA,Vinokuroff KE,等. 《国际分子科学杂志》. 2022;23(8):4115Dhaliwal NK, Razzaq L. Cureus. 2025;17(6):e86483. 达利瓦尔 NK,拉扎克 L。Cureus. 2025;17(6):e86483.Lundbeck. Data on file 灵北制药。存档数据Feldhaus AL, et al. Endocrinology 2017;158(1):1-8 Feldhaus AL 等.《内分泌学》2017;158(1):1-8Xing Y, et al. J Endocrinol 2011;209(3):327-35 邢 Y,等. 《内分泌学杂志》2011;209(3):327-35CONTACT: 联系方式:H. Lundbeck A/S H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark 丹麦瓦尔比,邮编2500,奥蒂利亚街9号+45 3630 1311 +45 3630 1311[emailprotected] [email protected]This information was brought to you by Cision 本信息由 Cision 提供http://news.cision.com http://news.cision.comhttps://news.cision.com/h--lundbeck-a-s/r/lundbeck-to-present-new-patient-data-on-neuroendocrine-and-neuroimmunology-programs-at-endo-2026,c4359848 https://news.cision.com/h--lundbeck-a-s/r/lundbeck-to-present-new-patient-data-on-neuroendocrine-and-neuroimmunology-programs-at-endo-2026,c4359848The following files are available for download: 以下文件可供下载:https://mb.cision.com/Main/18215/4359848/4142804.pdf https://mb.cision.com/Main/18215/4359848/4142804.pdfENDO curtain raiser_Final 内分泌学会年会开幕_终稿SOURCE H. Lundbeck A/S 来源:H. Lundbeck A/S21 二十一% 百分比more press release views with 更多新闻稿浏览量,借助Request a Demo 申请演示