BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

丹麦BALLERUP-（商业电线）-不适合英国使用-不适合英国媒体

LEO Pharma A/S, a global leader in medical dermatology, has today announced the First Subject First Treatment (FSFT) milestone for the Phase 2b clinical trial for temtokibart, LEO Pharma's IL-22RA1 antibody.2 The first patient dose was successfully administered on the 4th of October at the DermEdge Research Center in Ontario, Canada..

医学皮肤病学全球领导者LEO Pharma A/S今天宣布了temtokibart，LEO Pharma的IL-22RA1抗体2b期临床试验的第一个主题首次治疗（FSFT）里程碑.2第一个患者剂量成功实施10月4日在加拿大安大略省DermEdge研究中心。。

Temtokibart is an investigational monoclonal antibody currently in Phase 2 development for the treatment of moderate-to-severe atopic dermatitis (AD). The drug targets the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with AD.1,3,4 As IL-22RA1 is also involved in IL-20 and IL-24 signalling, temtokibart potentially also inhibits the effects of those two cytokines; however, this is not yet fully understood.1.

Temtokibart是目前处于2期开发阶段的用于治疗中度至重度特应性皮炎（AD）的研究性单克隆抗体。该药物靶向IL-22RA1受体亚基，从而抑制已知在AD患者中升高的白细胞介素-22（IL-22）细胞因子的作用。由于IL-22RA1也参与IL-20和IL-24信号传导，temtokibart也可能抑制这两种细胞因子的作用；但是，这还没有完全理解。

Following the completion of the Phase 2a trial,1 LEO Pharma has now initiated the LP0145-2240 trial. This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart in adult subjects with moderate-to-severe AD.2.

在完成2a期试验后，1 LEO Pharma现已启动LP0145-2240试验。这是一项2b期，随机，双盲，安慰剂对照，多点，平行组剂量发现试验，用于评估不同剂量皮下注射temtokibart对中度至重度AD成人受试者的疗效和安全性。

'We are committed to conducting clinical research to investigate potential new mechanisms of action,” said Kreesten Meldgaard Madsen, Chief Development Officer, Global Development LEO Pharma. “With this latest trial initiation, we continue to work towards potentially bringing additional treatments to people living with atopic dermatitis whose needs are not met by current treatments.”.

全球发展利奥制药公司首席发展官Kreesten Meldgaard Madsen说：“我们致力于开展临床研究以调查潜在的新行动机制。”。“通过最新的试验启动，我们继续努力为特应性皮炎患者提供额外的治疗，这些患者的需求目前的治疗无法满足。”。

“Despite advancements in the understanding of the disease, there are still patients that could benefit from additional treatment options for moderate-to-severe atopic dermatitis,' said Prof. Stephan Weidinger, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Germany and international coordinating investigator (ICI) for the Phase 2b trial.

德国石勒苏益格-荷尔斯泰因大学医院皮肤科和过敏科Stephan Weidinger教授说：“尽管对这种疾病的认识有所提高，但仍有患者可以从中重度特应性皮炎的其他治疗方案中受益。”国际协调研究人员（ICI）进行2b期试验。

“By targeting the IL-22 pathway, this trial could provide additional insights into the pathophysiology of atopic dermatitis.”.

“通过靶向IL-22途径，该试验可以为特应性皮炎的病理生理学提供额外的见解。”。

The Phase 2b trial will be overseen by a specialist steering committee, the purpose of which is to provide critical scientific guidance, oversee trial conduct and drive trial results, analysis and scientific communications.

2b期试验将由专家指导委员会监督，其目的是提供关键的科学指导，监督试验行为并推动试验结果，分析和科学交流。

The steering committee includes four international clinical experts:

指导委员会包括四名国际临床专家：

Prof. Stephan Weidinger (Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Germany)

Stephan Weidinger教授（德国石勒苏益格-荷尔斯泰因大学医院皮肤科和过敏科）

Prof. Emma Guttman-Yassky (Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, United States)

Emma Guttman-Yassky教授（美国纽约西奈山伊坎医学院皮肤科）

Prof. Michael Ardern-Jones (Department of Dermatology, Southampton General Hospital, University of Southampton, United Kingdom)

Michael Ardern Jones教授（英国南安普敦大学南安普敦总医院皮肤科）

Dr Chih-ho Hong (Board certified dermatologist working in Greater Vancouver, BC Canada)

洪志浩博士（加拿大卑诗省大温哥华工作的董事会认证皮肤科医生）

LEO Pharma and argenx jointly developed temtokibart under an exclusive option and research agreement. LEO Pharma obtained the license to temtokibart in 2022 and now assumes the responsibility to develop and commercialize the drug for inflammatory skin disorders, such as AD. The collaboration between LEO Pharma and argenx stands as a strong example of an external innovation sourcing model, which is a key pillar in LEO Pharma’s new Research and Development strategy..

LEO Pharma和argenx根据独家选择和研究协议共同开发了temtokibart。LEO Pharma于2022年获得temtokibart的许可，现在承担开发和商业化用于炎症性皮肤病（如AD）的药物的责任.LEO Pharma与argenx之间的合作是外部创新采购模式的一个强有力的例子，这是LEO Pharma新研发战略的关键支柱。。

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About atopic dermatitis

关于特应性皮炎

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.6

特应性皮炎是一种慢性炎症性皮肤病，以强烈的瘙痒和湿疹病变为特征[5]。特应性皮炎是皮肤屏障功能障碍和免疫失调导致慢性炎症的结果

About temtokibart

关于temtokibart

Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis.1 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24.1 Temtokibart does not bind to the IL-22 cytokine itself.1 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx..

Temtokibart是一种针对IL-22RA1受体亚单位的研究性单克隆抗体，目前正处于潜在治疗中重度特应性皮炎的2期临床试验阶段[1]。它阻断IL-22RA1亚单位，从而抑制IL-22细胞因子，并且在一定程度上也可能IL-20和IL-24.1的作用Temtokibart不与IL-22细胞因子本身结合.1 LEO Pharma已经获得了从argenx开发和商业化Temtokibart的全球独家许可。。

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

LEO Pharma是一家全球性公司，致力于提高护理标准，为皮肤病患者，家属和社会带来利益。LEO Pharma成立于1908年，多数由LEO基金会所有，致力于数十年的研究和开发以推进皮肤病学科学，如今，该公司为所有疾病严重程度提供广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion. Learn more at www.leo-pharma.com..

LEO Pharma总部设在丹麦，拥有4700人的全球团队，为全球数百万患者提供服务。2022年，该公司净销售额为106亿丹麦克朗。在www.leo-pharma.com了解更多信息。。

References

工具书类

Thaçi D, et al. Efficacy and safety of IL-22R inhibition in patients with moderate-to-severe atopic dermatitis: results from a phase 2a monotherapy trial. Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17–21 2023; New Orleans, LA.

Thaçidet al。中重度特应性皮炎患者IL-22R抑制的有效性和安全性：2a期单药治疗试验的结果。在2023年美国皮肤病学会年会上发表；2023年3月17日至21日；新奥尔良，洛杉矶。

ClinicalTrials.gov. National Library of Medicine (U.S.). A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis. Identifier: NCT05923099 https://classic.clinicaltrials.gov/ct2/show/NCT05923099.

ClinicalTrials.gov。国家医学图书馆（U.S.）。一项评估不同剂量LEO 138559在中重度特应性皮炎成人中的疗效和安全性的试验。标识符：NCT05923099https://classic.clinicaltrials.gov/ct2/show/NCT05923099.

Fujita H. The role of IL-22 and Th22 cells in human skin diseases. J Dermatol Sci. 2013;72(1):3-8.

Fujita H.IL-22和Th22细胞在人类皮肤病中的作用。J Dermatol Sci。2013;72(1):3-8.

Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and implications for targeted therapeutics. J Allergy Clin Immunol. 2019;143(1):1-11.

Czarnowicki T，He H，Krueger JG，Guttman-Yassky E.特应性皮炎内源性及其对靶向治疗的影响。J Allergy Clin Immunol。2019;143(1):1-11.

Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.

Weidinger S，Novak N.特应性皮炎。柳叶刀。2016;387(10023):1109-1122.

Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.

Boguniewicz M，Leung DY.特应性皮炎：皮肤屏障改变和免疫失调的疾病。Immunol Rev.2011；242(1):233-246.