UCB, a global biopharmaceutical company, today announced new 12-week efficacy and 18-week safety data from the Phase 1/2a first-in-patient trial for galvokimig, a novel multi-specific antibody-based therapeutic currently under clinical investigation for adults living with moderate-to severe atopic dermatitis (AD).

优时比（UCB），一家全球生物制药公司，今日宣布了来自galvokimig的1/2a期首次患者试验的12周疗效和18周安全数据，galvokimig是一种新型多特异性抗体疗法，目前正针对中重度特应性皮炎（AD）成人患者进行临床研究。

Galvokimig demonstrated clinically meaningful improvements in stringent efficacy measures for AD,.

Galvokimig 在 AD 的严格疗效指标方面表现出具有临床意义的改善。

a common, chronic, inflammatory skin disease affecting 2–10% of adults worldwide.

一种常见的、慢性的、影响全球2-10%成年人的皮肤炎症性疾病。

“The study showed that many patients achieved the stringent EASI75 and EASI90 outcomes at Week 12 with galvokimig in this early-stage trial. The data indicate the potential of galvokimig to deliver clinically meaningful improvements in larger-scale clinical trials for patients with atopic dermatitis,” said Professor Jonathan Silverberg,≠ MD, PhD, MPH, Professor of Dermatology at the George Washington University School of Medicine & Health Sciences in Washington, DC.

“研究表明，在这项早期试验中，许多患者在第12周达到了严格的EASI75和EASI90指标。数据表明，galvokimig有潜力在更大规模的特应性皮炎患者的临床试验中带来具有临床意义的改善，”乔治华盛顿大学医学院及健康科学学院皮肤病学教授乔纳森·西尔弗伯格（Jonathan Silverberg）博士、医学博士、公共卫生硕士表示。

“These encouraging results provide support for targeting both Th2 and Th17 inflammatory pathways in patients with this debilitating inflammatory disease and I look forward to results from the Phase 2b clinical program.”.

“这些令人鼓舞的结果为在患有这种使人衰弱的炎症疾病的患者中靶向Th2和Th17炎症通路提供了支持，我期待2b期临床项目的结果。”

In the Phase 2a trial, patients (n=47) received galvokimig (n=33) or placebo (n=14).

在 2a 期试验中，患者 (n=47) 接受了 galvokimig (n=33) 或安慰剂 (n=14)。

At Week 12, a median of 64.9% of patients achieved EASI75 with galvokimig versus 12.3% with placebo.

在第12周，使用galvokimig的患者中有64.9%达到了EASI75，而使用安慰剂的患者中仅有12.3%达到。

Also at Week 12, a median of 46.6% of patients achieved EASI90 with galvokimig versus 3.5% with placebo.

在第12周时，使用galvokimig的患者中有46.6%达到了EASI90，而使用安慰剂的患者中仅有3.5%达到。

After 18 weeks, the most common treatment-emergent adverse events (TEAEs) with galvokimig were rhinitis, nasopharyngitis, headache, dizziness and oropharyngeal pain.

18周后，使用galvokimig最常见的治疗相关不良事件（TEAEs）包括鼻炎、鼻咽炎、头痛、头晕和口咽痛。

“Atopic dermatitis is the most common, chronic, inflammatory skin disease, affecting millions of people across the world, that can have far-reaching consequences for the everyday lives of patients and their families,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. “Many patients experience sub-optimal treatment responses, in part due to the complex variety of inflammatory mechanisms involved in this disease, underscoring the need for new treatment options for those living with this distressing condition.”.

“特应性皮炎是最常见、慢性、炎症性皮肤病，影响着全世界数百万人，对患者的日常生活及其家人的生活产生深远影响，”优时比（UCB）医学主管兼首席医学官唐纳泰罗·克罗切塔表示。“许多患者的治疗效果不理想，部分原因是这种疾病涉及多种复杂的炎症机制，这凸显了为那些受此痛苦状况困扰的人群提供新治疗选择的必要性。”

Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide.

Galvokimig 目前正在临床研究中，尚未获得全球任何监管机构的批准。

UCB’s abstract on galvokimig will be presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, 17–20 September. The abstract complements the 19 other presentations from UCB in bimekizumab data across hidradenitis suppurativa, psoriasis, psoriatic arthritis and axial spondyloarthritis – emphasizing UCB’s strong commitment to addressing unmet health needs for people living with immune-mediated inflammatory diseases..

UCB关于galvokimig的摘要将在2025年9月17日至20日于法国巴黎举行的欧洲皮肤病与性病学会（EADV）大会上进行口头报告。该摘要补充了UCB在bimekizumab数据方面的其他19个报告，涵盖化脓性汗腺炎、银屑病、银屑病关节炎和轴向脊柱关节炎，彰显了UCB致力于满足免疫介导的炎症性疾病患者的未满足健康需求的坚定承诺。

NRI: non-responder imputation. All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response.

NRI：无应答者填补。因不良事件或缺乏疗效而停止治疗后的所有访视均被视为无应答。

EASI75/EASI90: A 75% and 90% or more improvement from baseline, respectively, in the Eczema Area and Severity Index (EASI).

EASI75/EASI90：湿疹面积和严重程度指数（EASI）相比基线分别提高75%和90%及以上。

The EASI assessment integrates body surface area of involvement and the intensity of lesional skin into one composite score.

EASI评估将受累体表面积和病灶皮肤的严重程度整合为一个综合评分。

About atopic dermatitis

关于特应性皮炎

Atopic dermatitis (AD) is a heterogeneous disease affecting both children and adults, and is driven by a combination of chronic inflammation, epidermal dysfunction and a dysregulated skin barrier.

特应性皮炎（AD）是一种异质性疾病，影响儿童和成人，由慢性炎症、表皮功能障碍和失调的皮肤屏障共同驱动。

AD is characterized by recurrent skin lesions presenting as erythematous patches with exudation, blistering and crusting at early stages, and lichenification at later stages, as well as intense itch.

AD 的特征是反复出现的皮肤病变，早期表现为红斑、渗出、水疱和结痂，后期表现为苔藓化，并伴有剧烈瘙痒。

AD affects 2–10% of adults and 15–30% of children worldwide.

AD影响全球2-10%的成人和15-30%的儿童。

The prevalence of AD has grown by 0.98% per decade in adolescents and by 1.21% per decade in children globally.

全球范围内，青少年AD的患病率每十年增长0.98%，儿童则每十年增长1.21%。

AD significantly lowers the quality of life for patients and their families, being associated with sleep disturbance,

阿尔茨海默病显著降低了患者及其家人的生活质量，与睡眠障碍相关，

anxiety, hyperactivity and depression.

焦虑、多动和抑郁。

About the first-in-human trial

关于首次人体试验

The study was a two-part, randomized, first-in-human, proof-of-concept, double-blind Phase 1/2a study of galvokimig monotherapy.

该研究是一项两部分、随机、首次人体、概念验证、双盲的1/2a期galvokimig单药治疗研究。

In part A of the study, healthy study participants received either placebo or single ascending doses of galvokimig administered by intravenous infusion or subcutaneous injection. In part B, patients with moderate-to-severe atopic dermatitis (AD) were randomized 2:1 to receive either galvokimig or placebo by intravenous infusion..

在研究的A部分，健康受试者接受安慰剂或通过静脉输注或皮下注射给予的单次递增剂量的galvokimig。在B部分，中度至重度特应性皮炎（AD）患者按2:1随机分配，接受galvokimig或安慰剂的静脉输注。

Patients with AD were enrolled in part B of the study and randomized 2:1 to receive intravenous galvokimig or placebo.

患有AD的患者被纳入研究的B部分，并以2:1的比例随机分配接受静脉注射galvokimig或安慰剂。

The primary endpoints  in part B were ≥75% improvement from baseline in Eczema Area and Severity Index (EASI75) response rate at Week 12 and incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs from baseline to Week 18.1

B部分的主要终点是从基线到第12周湿疹面积和严重指数（EASI75）反应率改善≥75%，以及从基线到第18.1周出现的治疗相关不良事件（TEAEs）和严重TEAEs的发生率。

About galvokimig

关于galvokimig

Galvokimig is a multi-specific antibody-based therapeutic that is designed to inhibit IL-13, IL-17A and IL-17F, with an extended half-life through albumin binding.

Galvokimig是一种基于多特异性抗体的治疗药物，旨在抑制IL-13、IL-17A和IL-17F，并通过与白蛋白结合延长半衰期。

By targeting both Th2 (via IL-13) and Th17 pathways (via IL-17A/F), combined IL-13, IL-17A and IL-17F inhibition with a single agent may improve treatment outcomes in people with atopic dermatitis.

通过同时针对 Th2（通过 IL-13）和 Th17 通路（通过 IL-17A/F），使用单一药物联合抑制 IL-13、IL-17A 和 IL-17F 可能改善特应性皮炎患者的治疗效果。

The safety and efficacy of galvokimig have not been established and it is not currently approved for use in any indication by any regulatory authority worldwide.

加尔沃基米尚未确立其安全性和有效性，且目前未获得全球任何监管机构的任何适应症使用批准。

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €6.1 billion in 2024.

优时比公司（UCB），位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物与解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有大约9,000名员工，并在2024年实现了61亿欧元的收入。