MADISON, N.J.--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

新泽西州麦迪逊（BUSINESS WIRE）--不供英国使用-不供英国媒体使用

LEO Pharma A/S, a global leader in medical dermatology, today presented for the first time key results from the DELTA 3 trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1 The presentation, which is the first of two LEO Pharma late-breaker presentations at AAD, is part of a wide-ranging data program with eight abstracts accepted in total for the meeting..

LEO Pharma A/S是医学皮肤病学的全球领导者，今天在加利福尼亚州圣地亚哥举行的第82届美国皮肤病学会（AAD）大会上，首次介绍了delgocitinib乳膏（一种研究性局部泛Janus激酶（JAK）抑制剂）的DELTA 3试验的关键结果。1该演讲是LEO Pharma在AAD上的两次迟发性演讲中的第一次，是一个范围广泛的数据计划的一部分，会议共接受了八篇摘要。。

For DELTA 3, subjects who completed the 16-week treatment period in one of the parent trials DELTA 1 and DELTA 2 were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks. In the periods when the disease is controlled within the 36 weeks, no treatment was administered.1.

对于DELTA 3，在父母试验DELTA 1和DELTA 2之一中完成16周治疗期的受试者，根据需要每天两次服用delgocitinib乳膏，以控制其慢性手部湿疹36周。在36周内疾病得到控制的时期，没有进行任何治疗。

The DELTA 3 extension trial (N=801) was designed to evaluate the long-term safety of as-needed treatment with delgocitinib cream, where the primary endpoint revealed that no new safety concerns were identified, demonstrating a safety profile consistent with the positive results of the DELTA 1 and DELTA 2 clinical trials.1 The most frequent treatment-emergent adverse events (TEAEs) were COVID-19 and nasopharyngitis.1.

DELTA 3延长试验（N=801）旨在评估delgocitinib乳膏按需治疗的长期安全性，主要终点显示未发现新的安全问题，证明安全性与DELTA 1和DELTA 2临床试验的阳性结果一致。1最常见的治疗紧急不良事件（TEAE）是COVID-19和鼻咽炎。

“This late-breaker presentation marks a proud moment in our journey to support the critical unmet need in chronic hand eczema,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Having the opportunity to present the DELTA 3 findings for the first time at AAD is a chance to prove our complete dedication to addressing the immense burden of this disease.

LEO Pharma首席开发官Kreesten Meldgaard Madsen说：“这次迟来的演讲标志着我们在支持慢性手部湿疹关键未满足需求的过程中的一个骄傲时刻。”。“有机会在AAD首次展示DELTA 3的发现，这是一个证明我们完全致力于解决这种疾病的巨大负担的机会。

By continuing to share our key data at major dermatology congresses, we hope to drive forward the clinical development of delgocitinib cream as a potential new treatment option.”.

通过继续在主要皮肤病学大会上分享我们的关键数据，我们希望推动delgocitinib乳膏的临床开发，作为一种潜在的新治疗选择。”。

Key secondary endpoints demonstrated an efficacy profile consistent with DELTA 1 and 2 parent trials. The proportion of patients achieving an Investigator's Global Assessment for CHE (IGA-CHE) score of 0/1 (clear/almost clear) and a ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) improved from baseline (24.6%, 51.8%, and 31.8%, respectively) to Week 36 (30.0%, 58.6%, and 36.6%, respectively) among delgocitinib cream-treated subjects in parent trials.

关键次要终点显示出与DELTA 1和2亲本试验一致的疗效概况。在父母试验中，研究者对CHE（IGA-CHE）评分为0/1（清晰/几乎清晰）和手部湿疹严重程度指数（HECSI-75/90）改善≥75%/≥90%的患者比例从基线（分别为24.6%，51.8%和31.8%）改善到第36周（分别为30.0%，58.6%和36.6%）。

Among those treated with cream vehicle in parent trials, response rates improved from baseline (9.1%, 23.7%, and 12.0%, respectively) to Week 36 (29.5%, 51.5%, and 35.7%, respectively).1.

在父母试验中用乳膏载体治疗的患者中，有效率从基线（分别为9.1%，23.7%和12.0%）提高到第36周（分别为29.5%，51.5%和35.7%）。

“The results from DELTA 3 offer hope to adults living with chronic hand eczema, a patient group who have been left to deal with their debilitating condition with minimal treatment options,” said Dr Melinda Gooderham, Lead Author and Medical Director at the SKiN Centre for Dermatology.

“DELTA 3的研究结果为患有慢性手部湿疹的成年人提供了希望，慢性手部湿疹是一个患者群体，他们只能以最少的治疗选择来应对虚弱的状况，”皮肤病学皮肤中心的首席作者兼医学主任梅琳达·古德汉姆博士说。

Alongside the presentation, new data sets at AAD were shared as e-posters from the preceding DELTA 1 and 2 trials regarding safety, efficacy and systemic exposure.2,3,4

除了介绍之外，AAD的新数据集还作为电子海报共享，这些电子海报来自之前的DELTA 1和2试验，涉及安全性，有效性和全身暴露。2,3,4

About the DELTA 1, 2 and 3 Trials

关于DELTA 1、2和3试验

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate-to-severe CHE.5,6.

随机，双盲，媒介物对照，多中心3期临床试验（DELTA 1和DELTA 2）的主要目的是评估每日两次应用delgocitinib乳膏与乳膏载体相比治疗成人中度至重度CHE的疗效[5,6]。

The primary endpoint of the DELTA 1 and DELTA 2 trials was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe)..

DELTA 1和DELTA 2试验的主要终点是研究者在第16周对慢性手部湿疹治疗成功率（IGA-CHE TS）的全球评估。治疗成功被定义为IGA-CHE评分为0（清晰）或1（几乎清晰），与基线相比至少有两步改善。其他IGA-CHE评分包括2（轻度），3（中度）和4（重度）。。

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.

第16周的关键次要终点包括从基线到第16周，手部湿疹症状日记（HESD）测量的瘙痒和疼痛评分降低≥4分，以及第16周手部湿疹严重程度指数（HECSI）比基线至少改善75%，比基线至少改善90%。

The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials..

从基线到第16周的治疗紧急不良事件的数量确定了试验的关键安全终点。。

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to enroll into the DELTA 3 extension trial. The purpose of this extension trial was to evaluate the long-term safety of twice-daily as needed treatment with delgocitinib cream.

在DELTA 1或DELTA 2试验中，每天两次用delgocitinib乳膏或乳膏载体完成16周治疗的受试者被提供参加DELTA 3延长试验。这项延长试验的目的是评估每日两次使用delgocitinib乳膏治疗的长期安全性。

Subjects visited the clinic every 4 weeks to assess the safety and efficacy of the treatment, as well as its effect on patient-reported outcomes (PROs) until Week 36, with a final follow-up phone call planned on Week 38.1.

受试者每4周访问一次诊所，以评估治疗的安全性和有效性，以及在第36周之前对患者报告结果（PRO）的影响，并计划在第38.1周进行最后的随访电话。

About Chronic Hand Eczema

关于慢性手部湿疹

Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.7,8 HE is the most common skin disorder of the hands9 with a one-year prevalence rate of approximately 9%.10 In a substantial number of patients, HE can develop into a chronic condition.9 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.11.

慢性手部湿疹（CHE）被定义为持续三个月以上或一年内复发两次或两次以上的手部湿疹（HE）。7,8他是手部最常见的皮肤病9，一年患病率约为9%。10在大量患者中，他可能会发展为慢性病。9 CHE是一种以瘙痒和疼痛为特征的波动性疾病，患者可能会出现红斑，鳞屑，苔藓化，角化过度，水泡，水肿以及手和手腕上的裂缝等症状。

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,12 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.13 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.14.

CHE已被证明会造成心理和功能负担，影响患者的生活质量[12]，大约70%患有严重CHE的人承认在日常活动中存在问题，并且由于这种情况而在日常生活中受到干扰.13此外，职业和收入潜力也被证明受到与CHE一起生活的负担的影响。

About delgocitinib

德尔戈西替尼

Delgocitinib cream is an investigational, potential first-in-class, topical pan-Janus kinase (JAK) inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.15 Delgocitinib has not been approved by any health authority. The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.16 LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults, which is currently not approved by any health authority.

Delgocitinib乳膏是一种用于CHE的研究性，潜在的一流局部泛Janus激酶（JAK）抑制剂。它抑制JAK-STAT信号的激活，JAK-STAT信号在CHE.15的发病机制中起关键作用。Delgocitinib尚未得到任何卫生当局的批准。病理生理学的特征是皮肤屏障功能障碍，皮肤炎症和皮肤微生物组的改变.16 LEO Pharma目前正在开发用于治疗成人中度至重度慢性手部湿疹（CHE）的乳膏制剂中的delgocitinib，目前尚未得到任何卫生当局的批准。

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights..

2014年，LEO Pharma A/S和日本烟草公司（JT）签订了一项许可协议，LEO Pharma获得了独家开发和商业化delgocitinib的权利，用于全球皮肤科适应症的局部使用，日本除外，JT保留权利。。

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.

利奥制药（LEO Pharma）是一家全球性公司，致力于提高护理标准，造福皮肤病患者及其家人和社会。LEO Pharma成立于1908年，由LEO基金会拥有多数股权。LEO Pharma致力于数十年的研究和开发，以推动皮肤病学的发展。如今，该公司为所有严重疾病提供了广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,300 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion..

利奥制药（LEO Pharma）总部位于丹麦，拥有4300人的全球团队，为全球数百万患者提供服务。2023年，该公司净销售额为114亿丹麦克朗。。

References

参考文献

Gooderham M, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CAx

Gooderham M等人。delgocitinib乳膏在成人慢性手部湿疹患者中长达36周的长期安全性和有效性：3期开放标签扩展DELTA-3试验的结果。在2024年美国皮肤病学会年会上发表；2024年3月8日至12日；加利福尼亚州圣地亚哥

Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the Phase 3 DELTA-1 and -2 trials. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA.

Bissonnette R等人。delgocitinib乳膏治疗成人中度至重度慢性手部湿疹的疗效和安全性：3期DELTA-1和-2试验的汇总结果。在2024年美国皮肤病学会年会上发表；2024年3月8日至12日；加利福尼亚州圣地亚哥。

Bauer A, et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe chronic hand eczema: pooled analyses of the Phase 3 DELTA-1 and -2 trials. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA.

Delgocitinib乳膏可减轻中重度慢性手部湿疹患者的瘙痒和疼痛：3期DELTA-1和-2试验的汇总分析。在2024年美国皮肤病学会年会上发表；2024年3月8日至12日；加利福尼亚州圣地亚哥。

Gooderham M, et al. Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe chronic hand eczema in the Phase 3 DELTA-2 trial. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA.

Gooderham M等人。delgocitinib乳膏在3期DELTA-2试验中对患有中度至重度慢性手部湿疹的成年人的全身暴露和安全性概况。在2024年美国皮肤病学会年会上发表；2024年3月8日至12日；加利福尼亚州圣地亚哥。

ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. https://clinicaltrials.gov/study/NCT04871711.

ClinicalTrials.gov。国家医学图书馆（美国）。Delgocitinib乳膏治疗成人中重度慢性手部湿疹（DELTA 1）的疗效和安全性。标识符：NCT04871711。https://clinicaltrials.gov/study/NCT04871711.

ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.

ClinicalTrials.gov。国家医学图书馆（美国）。Delgocitinib乳膏治疗成人中重度慢性手部湿疹（DELTA 2）的疗效和安全性。标识符：NCT04872101。https://clinicaltrials.gov/ct2/show/NCT04872101.

Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.

Lynde C，Guenther L，Diepgen TL等。加拿大手部皮炎管理指南。J Cutan Med Surg。2010；14（6）：267-284。

Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.

Diepgen TL，Andersen KE，Chosidow O等。手部湿疹的诊断，预防和治疗指南。J Dtsch皮肤病杂志。2015年；13（1）：e1-e22。

Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.

Bissonnette R，Diepgen TL，Elsner P等。重新定义慢性手部湿疹（CHE）的治疗选择。J Eur Acad Dermatol Venereol。2010年；24补充3:1-20。

Thyssen JP, Johansen JD, Linneberg A, Menné T. The epidemiology of hand eczema in the general population--prevalence and main findings. Contact Dermatitis. 2010;62(2):75-87.

Thyssen JP，Johansen JD，Linneberg A，MennéT.普通人群手部湿疹的流行病学-患病率和主要发现。接触性皮炎。2010年；62（2）：75-87。

Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.

Thyssen JP，Schuttelaar MLA，Alfonso JH等。手部湿疹的诊断、预防和治疗指南。接触性皮炎。2022年；86（5）：357-378。

Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.

Grant L，Seiding Larsen L，Burrows K等。基于对患者和专家皮肤科医生的定性访谈，开发慢性手部湿疹（CHE）的概念模型。高级Ther。2020年；37（2）：692-706。

Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.

Cortesi PA，Scalone L，Belisari A等。局部强效皮质类固醇标准治疗难治的严重慢性手部湿疹患者的成本和生活质量。接触性皮炎。2014年；70（3）：158-168。

Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.

沃伯格·安（Voorberg AN），洛曼·L（Loman L），舒特拉尔（Schuttelaar MLA）。荷兰普通人群手部湿疹的患病率和严重程度：生命线队列研究中的横断面问卷研究。性病学报。2022年；102:adv00626。

Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332.

Dubin C，Del Duca E，Guttman Yassky E.治疗慢性手部湿疹的药物：成功和关键挑战。临床风险管理。2020年；16： 1319-1332年。

Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema.Dermatol Ther. 2019;32(3):e12840.

Lee GR，Maarouf M，Hendricks AK，Lee DE，Shi VY。手部湿疹的当前和新兴疗法。皮肤病。2019年；32（3）：e12840。

MAT-71600 March 2024

MAT-71600 2024年3月