LEO Pharma Announces Publication of Chronic Hand Eczema Phase 3 Data in The Lancet

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BALLERUP, Denmark, July 19, 2024 – LEO Pharma A/S, a global leader in medical dermatology, today announced that the findings of the DELTA 1 and DELTA 2 phase 3 clinical trials for delgocitinib cream have been published in The Lancet,¹ which is considered one of the most influential peer-reviewed periodicals in the world. This is the first time The Lancet has published data on an investigational topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. 

The publication summarizes the randomized, double-blinded, multi-center vehicle-controlled clinical phase 3 DELTA 1 and DELTA 2 trials. These trials evaluated the safety and efficacy of investigational delgocitinib cream compared to cream vehicle in adult patients with moderate to severe CHE who had inadequate response to, or for whom topical corticosteroids were medically inadvisable.^2,3 Delgocitinib cream is currently under investigation and has not been approved by any health authority. 

“Having the DELTA 1 and 2 trial results featured in one of the most highly regarded peer-reviewed medical journals in the world is a vital step on our mission to raise awareness and develop potential new treatment options for those living with CHE,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “The publication of our research in The Lancet is a proud milestone for everyone who has worked tirelessly on the DELTA 1 and 2 trials, and proves LEO Pharma’s commitment to pioneering new potential treatment options for those living with skin conditions. We are excited to share this analysis with the broader scientific and medical community to help drive further research advances for CHE.”  

Primary and all secondary endpoints were met in both DELTA 1 and DELTA 2 trials.^2,3 

“Historically, CHE has been under researched, so the publication of the DELTA 1 and 2 trials in The Lancet is a positive step towards highlighting the condition, and in turn indicates the increased quality and rate of research in the space,” commented, Dr. Robert Bissonnette, Lead Author and MD from Innovaderm Research, Montreal. “Publication of milestones like this have a valuable role in our efforts to improve the day-to-day reality of those living with CHE.” 

About The Lancet 

The Lancet is a world-leading source of clinical, public health, and global health knowledge. Lancet journals have an extensive global reach with more than 36.6 million annual visits and 108.1 million downloaded articles.⁴ 

About the DELTA 1, 2 and 3 Trials   

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 safety and efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE.^2,3   

The primary endpoint of the 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).^2,3 

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. The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials. ^2,3   

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 roll-over to the DELTA 3 open-label, multi-site 36 week, extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.⁵ 

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.^6.7 HE is the most common skin disorder of the hands with a one-year prevalence rate of approximately 9%.^8,9 In a substantial number of patients, HE can develop into a chronic condition.⁸ 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.¹⁰  

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹¹ 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.¹² Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹³ 

About delgocitinib cream  

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.¹⁴ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹⁵ 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. 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.   

About 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 is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.   

Contacts:    Jes Broe Frederiksen   Global Commercial Communication    +45 53 60 59 48    jebfe@leo-pharma.com

References 

1. 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; published online July 18. https://doi.org/10.1016/S0140-6736(24)01027-4. 

1. 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/NCT04872101.   

1. 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.   

1. The Lancet. About The Lancet. Published: 2024. Last assessed: Jun 25, 2024. Available at: https://www.thelancet.com/lancet/about.  

1. 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 (DELTA3). Identifier: NCT04949841 https://clinicaltrials.gov/ct2/show/NCT04949841.    

1. 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. 

1. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.  

1. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.  

1. Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.  

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

1. 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. 

1. 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.  

1. 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. 

1. 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. 

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

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