Alitretinoin

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

GlobalData highlighted a handful of therapeutics currently under investigation as chronic hand eczema treatments including Leo Pharma's delgocitinib cream, Sanofi and Regeneron's blockbuster biologic Dupixent and new molecules from clinical-stage biotechs Asana BioSciences and Afecta Pharmaceuticals. Current treatments for chronic hand eczema (CHE) generally fall into two buckets: Either they battle inflammation but lead to unwanted side effects with long-term use or they soothe external symptoms without solving underlying inflammation.The lack of any approved treatments that are helpful in managing both the disease and its symptoms without tacking on any major side effects has created a significant gap in the CHE space that may be filled by up-and-coming treatments, according to a new report from GlobalData.“Overall, current treatment options for CHE, such as topical corticosteroids, emollients, immunosuppressants, and phototherapy, may improve the condition, but all have limitations,” Filippos Maniatis, a healthcare analyst for the firm, said in a statement. “Nevertheless, to address the unmet needs in CHE treatment, further research and clinical trials that focus on safety and the patient’s [quality of life] are essential.”To that end, GlobalData highlighted a handful of therapeutics currently under investigation as CHE treatments that might fit the bill. Sanofi and Regeneron are in the process of testing out blockbuster biologic Dupixent in the indication, for one, and clinical-stage biotechs Asana BioSciences and Afecta Pharmaceuticals are both studying new molecules in the CHE arena.Leo Pharma, meanwhile, announced this fall that it had submitted its delgocitinib cream for FDA approval as a treatment for adults with moderate to severe CHE for whom topical corticosteroids either have been inadequate or are not advisable. At the same time, the company shared that the treatment had been approved in the indication in Europe, where it’s now marketed under the name Anzupgo.If approved by the FDA, Anzupgo would become the first treatment specifically indicated for CHE in the U.S. GSK previously attempted to earn that title with alitretinoin, the exclusive global rights to which it had purchased from Basilea Pharmaceutica in 2012. Before that, the drug had raked in several international approvals as Toctino for severe CHE.By 2016, however, GSK had given up on attempting to bring Toctino to the U.S., abruptly announcing in January of that year that it was bailing on its stateside goals for the drug.Toctino, which remains available in more than two dozen countries outside the U.S., has been proven in studies to offer “good efficacy in eczema clearance,” per GlobalData, but “research investigating new therapeutic agents, including biologics and small molecules targeting specific inflammatory pathways, may provide better alternatives to the current standard of care for CHE.”As Maniatis pointed out in the report, Leo’s Anzupgo outperformed Toctino in a recent head-to-head study. The DELTA FORCE phase 3 trial pitted the Anzupgo cream against oral alitretinoin capsules; after 12 weeks, those who received Leo’s treatment demonstrated a “significantly greater least squares mean decrease” in their hand eczema severity index (HECSI) scores compared to those who took alitretinoin, achieving the study’s primary endpoint, according to a September release from the company. The Anzupgo group saw their HECSI scores drop an average 67.6 points on the 360-point scale, compared to 51.5 points among the Toctino group.Those on Anzupgo also reported “sizable” improvements in their health-related quality of life over the course of the study and experienced fewer treatment-related adverse events than the alitretinoin group, per Leo.