Delgocitinib

BALLERUP, Denmark--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results of the DELTA TEEN trial. DELTA TEEN is a pivotal phase 3 clinical trial with Anzupgo ® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of adolescents (aged 12-17) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate. 1 This is the fifth phase 3 Anzupgo trial to achieve primary and all key secondary endpoints, validating the results of the previous clinical trials from the DELTA program. 1,3-10 DELTA TEEN expands LEO Pharma’s growing portfolio of scientific evidence for the treatment of moderate to severe CHE, offering insight into a new patient population. Currently, no treatment options are approved specifically for moderate to severe CHE in the adolescent population. " Research on adolescents with CHE has revealed that the condition can considerably affect their quality of life, including psychosocial well-being, school performance and leisure activities," said Professor Sonja Molin, Academic Dermatologist at Charite Universitätsmedizin Berlin and Adjunct Associate Professor of Dermatology at Queen’s University and coordinating investigator. " These findings further our understanding of how moderate to severe CHE manifests in adolescents and how to support this underserved patient group." The trial met the primary endpoint with a statistically significant improvement in CHE symptoms after 16 weeks of treatment with Anzupgo compared to cream vehicle. 1 Furthermore, the safety profile of Anzupgo was consistent with previous pivotal trials. 1 “ The positive results from DELTA TEEN are encouraging and in line with LEO Pharma’s purpose of serving more and more people living with this debilitating condition,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma . “ Anzupgo is already available to adults in some markets, including Germany, and it is a critical next step to address the unmet need in this younger patient population.” Currently, Anzupgo is approved for adults in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States. Detailed results from DELTA TEEN are planned to be submitted for scientific presentation and publication at a later date. For more information on the DELTA TEEN trial (NCT05355818) go to clinicaltrials.gov . Notes to editors About Anzupgo ® (delgocitinib) cream Anzupgo is currently approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo is under investigation in other markets, including the United States. Anzupgo ® (delgocitinib) cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 11 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 12 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 cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About the DELTA TEEN Trial DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of Anzupgo compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE. 1 The primary endpoint of DELTA TEEN 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. 1 About Chronic Hand Eczema 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. 13,14 HE is the most common skin disorder of the hands 15 with a prevalence rate of approximately 4.7%. 16 In a substantial number of patients, HE can develop into a chronic condition. 15 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. 17 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 18 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. 19 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 20 About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of EUR 1.5 billion. References ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818 . Haft MA, Park HH, Lee SS, Sprague JM, Eichenfield LF. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173. 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/ct2/show/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. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA 3). Identifier: NCT04949841 https://clinicaltrials.gov/ct2/show/NCT04949841 . Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4. Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0395. Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0369. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://clinicaltrials.gov/study/NCT05259722 . Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: 24-week Phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Late Breaking News Session. D1T01 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. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. 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. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360. 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. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;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. 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. 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. MAT-79328 February 2025

Gilead Sciences and LEO Pharma have entered into a strategic partnership worth $1.7bn to advance LEO’s small molecule oral STAT6 programme for inflammatory diseases. The deal gives Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US. In exchange, LEO will be eligible for up to $1.7bn, including an upfront payment of $250m and approximately $1.5bn in development, regulatory and commercial milestones. LEO may also receive tiered royalties on sales of oral STAT6 products, while Gilead could be in line for tiered royalties on sales of topical STAT6 products. Flavius Martin, executive vice president, research, Gilead, said the company is “committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block major pathogenic pathways, eliminate pathogenic cells, tolerise the immune system, and restore cell function”. “By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring forward an oral option for patients suffering from chronic inflammatory conditions,” he added. STAT6 is the specific transcription factor used for interleukin-4 and interleukin-13 cytokine signalling, which has been shown to play a key role in multiple inflammatory conditions, including atopic dermatitis, asthma and chronic obstructive pulmonary disease. The approach has already shown potential pre-clinically to treat a broad population of patients and provide an oral alternative to those currently receiving injectable biologics. “STAT6 holds potential for treating various inflammatory diseases, including outside dermatology,” said LEO’s chief executive officer, Christophe Bourdon. “This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 programme and maximise its potential in dermatology and beyond.” The announcement comes just over a month after LEO’s Anzupgo (delgocitinib) cream was approved by the Medicines and Healthcare Products Regulatory Agency to treat chronic hand eczema in adults with moderate-to-severe cases of the inflammatory skin disease. The company is now working with the National Institute for Health and Care Excellence to make the treatment available on the NHS.