LEO Pharma Unveils Late-Breaking Data for Landmark DELTA 3 Open-Label Extension Trial at the 2024 AAD Annual Meeting

• Continuing the momentum for LEO Pharma at the ongoing American Academy of Dermatology (AAD) Annual Meeting, a late-breaker presentation shared positive results from the pivotal DELTA 3 trial.¹
• The trial investigated delgocitinib cream for the treatment of adults with moderate-to-severe chronic hand eczema (CHE), a condition with a considerable unmet need.
• Results show that investigational delgocitinib cream had a safety and efficacy profile consistent with preceding DELTA 1 and 2 trials.¹
• New data cuts from the DELTA parent trials on safety, efficacy and systemic exposure complete the extensive data program for delgocitinib cream shared at the meeting.^2,3,4

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

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 82^nd 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.

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

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

“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. 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.”

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. 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

“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.

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

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 efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate-to-severe CHE.^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).

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.

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. 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

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.^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

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

About delgocitinib
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. 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 4,300 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
8. 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.
9. 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.
10. 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.
11. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
12. 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.
13. 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.
14. 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.
15. 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.
16. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema.Dermatol Ther. 2019;32(3):e12840.

MAT-71600 March 2024