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The ongoing American Academy of Dermatology (AAD) annual meeting continued LEO Pharma's momentum, with late presentations sharing positive results from the pivotal DELTA 3 study.1
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This trial investigated delgocitinib cream for the treatment of adults with moderate to severe chronic hand eczema (CHE), a condition with significant unmet need.
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Results show that the safety and efficacy profile of the investigational delgocitinib cream is consistent with previous DELTA 1 and 2 trials.1
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New data cuts from the DELTA parent study on safety, efficacy, and systemic exposure completed the extensive data program for delgocitinib cream shared at the meeting.2, 3, 4
Madison, NJ, March 9, 2024–(Business Wire)–Not intended for use in the UK – Not intended for UK media
LEO Pharma A/S, a global leader in medical dermatology, today announced at the 82nd World Congress the importance of the DELTA 3 trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK) inhibitor. The results were announced for the first time.n.d. American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.1 This presentation was the first of two late presentations for LEO Pharma at AAD and is part of a broader data program that saw a total of eight abstracts accepted at the meeting.
In Delta 3, subjects who completed the 16-week treatment period in either parent studies Delta 1 and Delta 2 were treated for 36 weeks with delgocitinib cream twice daily as needed to control chronic hand eczema . No treatment was given during the period when the disease was under control for less than 36 weeks.1
The DELTA 3 extension study (N=801) was designed to evaluate the long-term safety of as-needed treatment with delgocitinib cream, and the primary endpoint showed that no new safety concerns were identified. demonstrated a safety profile consistent with positive results. DELTA 1 and DELTA 2 clinical trial results.1 The most frequent treatment-emergent adverse events (TEAEs) were COVID-19 and nasopharyngitis.1
“This belated presentation represents a proud moment in our commitment to support a critical unmet need in chronic hand eczema,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. states. “Having the opportunity to present the DELTA 3 study results for the first time at AAD is an opportunity to demonstrate our dedication to addressing the immense burden of this disease. By continuing to share important data, we hope to move forward with the clinical development of delgocitinib cream as a potential new treatment. ”
Key secondary endpoints demonstrated an efficacy profile consistent with the DELTA 1 and 2 parent trials. Proportion of patients with Physician Global Assessment of CHE (IGA-CHE) score of 0/1 (clear/nearly clear) and Hand Eczema Severity Index (HECSI-75/90) improvement of ≥75%/≥90% Proportion of delgocitinib cream-treated subjects in the parent study who improved from baseline (24.6%, 51.8%, and 31.8%, respectively) to week 36 (30.0%, 58.6%, and 36.6%, respectively). Response rates for patients treated with cream vehicle in the parent study improved from baseline (9.1%, 23.7%, and 12.0%, respectively) to week 36 (29.5%, 51.5%, and 35.7%, respectively).1
“The DELTA 3 results bring hope to adults living with chronic hand eczema, a group of patients who must cope with debilitating symptoms with minimal treatment options,” said lead author and director of the SKiN Center. said Medical Director Dr. Melinda Gooderham. Dermatology.
Alongside the presentation, new datasets from the previous DELTA 1 and 2 studies on safety, efficacy, and systemic exposure in AAD were shared as an e-poster.2, 3, 4
About DELTA 1, 2, 3 trials
The primary objective of the randomized, double-blind, vehicle-controlled, multicenter, phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily application of delgocitinib cream in treating the disease. It was to be evaluated in comparison with the vehicle. Adults with moderate to severe CHE.5,6
The primary endpoint for the DELTA 1 and DELTA 2 studies was the Investigator Global Assessment of Chronic Hand Eczema Treatment Success (IGA-CHE TS) at week 16. Successful treatment is defined as an IGA-CHE score of 0 (clear) or 1 (nearly clear) improvement of at least 2 grades from baseline. Additional IGA-CHE scores include 2 (mild), 3 (moderate), and 4 (severe).
Key secondary endpoints at week 16 included a 4-point or greater reduction in itch and pain scores as measured by the Hand Eczema Symptom Diary (HESD) from baseline to week 16, at least 75% from baseline. improvements of at least 90% from baseline. Baseline Hand Eczema Severity Index (HECSI) from baseline to week 16. The number of adverse events occurring during treatment from baseline to week 16 defined the primary safety endpoint of the trial.
Subjects who completed 16 weeks of treatment with twice-daily delgocitinib cream or cream vehicle in the DELTA 1 or DELTA 2 study were offered enrollment in the DELTA 3 extension study. The purpose of this extension study was to evaluate the long-term safety of her twice-daily on-demand treatment with delgocitinib cream. Subjects visited the clinic every 4 weeks to assess treatment safety and efficacy and impact on patient-reported outcomes (PROs) through week 36, with a final follow-up call scheduled at week 38. .1
About chronic hand eczema
Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts more than 3 months or recurs more than once within 1 year.7,8 HE is the most common skin disease of the hands9 The 1-year prevalence is approximately 9%.Ten In a significant number of patients, HE can develop into a chronic disease.9 CHE is a fluctuating disease characterized by itching and pain, and patients may experience symptoms such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists.11
CHE has been shown to cause psychological and functional burden that affects patients' quality of life.12 Approximately 70% of people with severe CHE have trouble carrying out daily activities and admit that their condition interferes with their daily life.13 Furthermore, career and earning potential have also been shown to be affected by the burden of living with CHE.14
About delgocitinib
Delgocitinib cream is an investigational, potential first-in-class topical pan-Janus kinase (JAK) inhibitor for CHE. This inhibits the activation of JAK-STAT signaling, which plays an important role in the development of CHE.15 Delgocitinib has not been approved by any health authority. The pathophysiology is characterized by skin barrier dysfunction, skin inflammation, and changes in the skin microbiome.16 LEO Pharma is currently developing a cream formulation of delgocitinib for the treatment of moderate to severe chronic hand eczema (CHE) in adults, but it is not currently approved by any health authority. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement under which LEO Pharma will sell products for topical use in dermatological indications worldwide, except in Japan, where JT holds the rights. obtained exclusive rights to develop and commercialize delgocitinib.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing standards of care for the benefit of people with skin diseases, their families, and society. Founded in 1908 and majority owned by his LEO Foundation, LEO Pharma has dedicated decades of research and development to advancing dermatology and now offers a wide range of treatments for all disease severities. Masu. Headquartered in Denmark, LEO Pharma has a global team of 4,300 people and serves millions of patients worldwide. The company's net sales in 2023 were DKK 11.4 billion.
References
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Gooderham M, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with chronic hand eczema: Results from the phase 3 open-label extension DELTA-3 study. Presented at the 2024 American Academy of Dermatology Annual Meeting. March 8-12, 2024.San Diego, California
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Bissonnette R et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: combined results from phase 3 DELTA-1 and -2 studies. Presented at the 2024 American Academy of Dermatology Annual Meeting. March 8-12, 2024. San Diego, California.
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Bauer A et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe chronic hand eczema: a combined analysis 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, California.
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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, California.
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ClinicalTrials.gov. National Library of Medicine (USA). Efficacy and safety of delgocitinib His cream in adults with moderate to severe chronic hand eczema (Delta 1). Identifier: NCT04871711. https://clinicaltrials.gov/study/NCT04871711.
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ClinicalTrials.gov. National Library of Medicine (USA). Efficacy and safety of delgocitinib His cream in adults with moderate to severe chronic hand eczema (Delta 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.
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Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
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Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for the diagnosis, prevention, and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.
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Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options for chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Supplement 3:1-20.
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Thyssen JP, Johansen JD, Linneberg A, Menné T. Epidemiology of hand eczema in the general population – prevalence and main findings. Contact dermatitis. 2010;62(2):75-87.
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Thyssen JP, Schutteler MLA, Alfonso JH Guidelines for the diagnosis, prevention, and treatment of eczema on other hands. Contact dermatitis. 2022;86(5):357-378.
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Grant L, Siding-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. Advancetel. 2020;37(2):692-706.
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Cortesi PA, Scalone L, Belisari A, et al. Costs and quality of life in patients with severe chronic hand eczema refractory to standard treatment with potent topical corticosteroids. Contact dermatitis. 2014;70(3):158-168.
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Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and severity of hand eczema in the Dutch general population: a cross-sectional questionnaire study in the Lifeline Cohort Study. Actaderm venereol. 2022;102:adv00626.
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Dubin C, Del Duca E, Guttman-Yassky E. Medications for the treatment of chronic hand eczema: successes and major challenges. Clean risk management. 2020;16:1319-1332.
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Lee GR, Malouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging treatments for hand eczema. Dermatol Ther. 2019;32(3):e12840.
MAT-71600 March 2024
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contact address
jess bro frederiksen
Senior Manager, Global Product and Data Communications, LEO Pharma
Phone number: +45 53 60 59 48
Email: jebfe@leo-pharma.com
melissa boland
Senior Manager of Communications, LEO Pharma – North America
Phone: + 1 647 241 1475
Email: MQBCA@leo-pharma.com