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• Phase 3 DELTA 2 results demonstrated that delgocitinib cream provided statistically significant improvements in both patient- and clinician-reported efficacy outcomes compared to cream vehicle, building on the data from the identically designed DELTA 1 trial.^1,2
• Additional analysis from the DELTA 2 trial concluded that twice-daily application of delgocitinib cream resulted in minimal systemic exposure, further supporting its safety profile.³

LEO Pharma A/S, a global leader in medical dermatology, today presented results from the DELTA 2 trial at the 32^nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin. DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).^1,4

DELTA 2 was a randomized, double-blind, cream vehicle-controlled trial. Adults were randomized to either twice-daily delgocitinib cream (n=314) or cream vehicle (n=159) for 16 weeks followed by a separate 36-week extension trial. The primary endpoint was the proportion of patients with moderate to severe CHE who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) or 1 (almost clear: barely perceptible erythema only) with a ≥2 point improvement from baseline at Week 16. A significantly greater proportion of delgocitinib-treated patients, compared to cream vehicle, achieved this IGA-CHE improvement (29.1% vs. 6.9%; p<0.001).¹

The trial also achieved its key secondary endpoints at Week 16, including a significantly greater proportion of delgocitinib-treated patients achieving a ≥75% improvement in the Hand Eczema Severity Index (HECSI-75) compared to cream vehicle (49.5% vs. 18.2%; p<0.001).¹ All endpoints were consistent with those previously reported from the identically designed DELTA 1 study, whose key results are also being presented at EADV this year.²

An additional analysis of DELTA 2 concluded that twice-daily application of delgocitinib cream in adults with moderate to severe CHE resulted in minimal systemic exposure over 16 weeks, further supporting its safety profile.³

"There is a high unmet need for a topical treatment tailored specifically for CHE,” said Dr Jacob Pontoppidan Thyssen, Executive Vice President and Chief Scientific Officer at LEO Pharma. “Through assessment of the DELTA 1 and DELTA 2 trial results, we aim to assess the efficacy and safety of delgocitinib cream in adults living with this hard-to-treat disease."

“This latest collection of clinical data for delgocitinib cream supports LEO Pharma’s unwavering commitment to addressing the critical unmet need in CHE,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "We strive to better support this vastly underserved patient population by investigating a potential new treatment option to treat CHE."

Other delgocitinib cream presentations at EADV include an overview and validation of IGA-CHE and Hand Eczema Symptom Diary (HESD) as study endpoints in the DELTA 1, 2 and 3 trials,^5,6 a systematic literature review of existing randomized controlled trial evidence for the treatment of moderate to severe CHE in adults,⁷ and a pooled analysis of the DELTA 1 and 2 trials examining the effect of delgocitinib cream on health-related quality of life.^8,9

*Ends*

About the DELTA 1 and 2

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.^4,10

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).

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.

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.^11,12 HE is the most common skin disorder of the hands¹³ with a one-year prevalence rate of approximately 9%.¹⁴ In a substantial number of patients, HE can develop into a chronic disease.¹³ 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.¹⁵

About delgocitinib

Delgocitinib is a first-in-class investigational topical pan-Janus kinase (JAK) inhibitor. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹⁶ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹⁷ LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults. 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 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

References

1. 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.
2. 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.
3. Thaçi D, et al. Minimal systemic exposure of delgocitinib cream in adults with moderate to severe chronic hand eczema in 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 #P0396.
4. 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.
5. Molin, S, et al. Development and psychometric validation of a new patient-reported outcome measure to assess the signs and symptoms of chronic hand eczema (CHE): the Hand Eczema Symptom Diary (HESD). Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0398.
6. Silverberg, J, et al. Psychometric Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0399.
7. Warren, R, et al. Treatments in chronic hand eczema: A systematic literature review of randomised controlled trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0433.
8. Bauer A, et al. Delgocitinib cream 20 mg/g improves health-related quality of life (EQ-5D) in patients with moderate-to-severe chronic hand eczema: pooled results from two randomised, controlled phase 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0421.
9. Schuttelaar ML, et al. Effect of delgocitinib cream 20 mg/g on Dermatology Life Quality Index in patients with moderate-to-severe chronic hand eczema: pooled data from the DELTA 1 and DELTA 2 phase 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0420.
10. 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.
11. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
12. 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.
13. 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.
14. 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.
15. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
16. 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.
17. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.

MAT-68781 October 2023

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