LEO Pharma Presents New Late-Breaking Delgocitinib Cream Data For the Third Consecutive Year at AAD 2025

The post hoc analysis investigated treatment responses in a patient subgroup with moderate to severe Chronic Hand Eczema (CHE) treated with delgocitinib cream for 16 weeks in the DELTA 1 2 phase 3 trials.1 Late-breaking presentation showcased that delgocitinib cream produced a deep, consistent and/or maintained response in a subgroup of patients with moderate to severe Chronic Hand Eczema (CHE).1 Separate data presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting evaluated systemic exposure in patients following high use of delgocitinib cream to treat moderate to severe CHE.2NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today presented late-breaking data showcasing responses in a subgroup of patients from the DELTA 1 and 2 trials at the 83^rd American Academy of Dermatology (AAD) 2025 Annual Meeting.¹

The presentation marks the third consecutive year that LEO Pharma has presented late-breaking data at AAD. Alongside this presentation, new systemic exposure data has also been shared for delgocitinib cream at the meeting.²

“The data unveiled today further contributes to LEO Pharma’s ever-growing body of scientific evidence for the treatment of moderate to severe CHE,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma. “Our research and work in CHE is a testament to our ambition to maintain the broadest global product portfolio in dermatology, and I am proud we can share this latest analysis from our pivotal DELTA trials.”

Delgocitinib cream is currently under investigation in the United States.

Late-Breaking Post Hoc Data Analysis

The subgroup analysis presented was based on the treatment response in patients with moderate to severe CHE treated with delgocitinib cream for 16 weeks compared to patients treated with the cream vehicle in the DELTA 1 and DELTA 2 trials. The subgroup in this analysis was defined as patients with either a deep, consistent and/or maintained treatment response.¹

The findings from the post hoc analysis highlight that delgocitinib cream produced a strong treatment response across this subgroup of patients.

A deep response, defined as a Hand Eczema Symptom Diary (HESD) itch of 0 (clear) or 1 (almost clear), HESD pain 0/1, and/or a Dermatology Life Quality Index (DLQI) score of 0/1 at Week 16, was achieved by more patients receiving delgocitinib cream versus the cream vehicle. At Week 16, 30.0% vs 9.4% of patients achieved a HESD itch of 0/1, 35.2% vs 16.0% achieved HESD pain 0/1, and 33.3% vs 13.9% achieved a DLQI score of 0/1.¹

Greater percentages of patients receiving delgocitinib cream versus the cream vehicle over the trial period achieved a consistent response of at least a 4-point reduction from baseline in HESD itch (24.1% vs. 6.6%) or pain (25.0% vs. 9.0%) or at least 75% improvement on the Hand Eczema Severity Index (HECSI-75) (27.3% vs. 8.1%).¹

A maintained response was defined as achieving an Investigator’s Global Assessment (IGA)-CHE of 0 (clear) at Week 16 and maintaining IGA-CHE 0 off treatment. Among patients receiving delgocitinib cream who achieved an IGA-CHE score of 0 at Week 16, 32.9% maintained a score of 0 after 8 weeks and 15.7% after 16 weeks.¹

“It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream,”said April W Armstrong, MD, Professor and Chief of Dermatology at the University of California-Los Angeles (UCLA). “The results across the various treatment metrics are promising and demonstrate the future potential that delgocitinib cream may have in offering a new treatment option for those living with this unique and burdensome disease.”

Systemic Exposure Analysis

Alongside the late-breaker presentation, new systemic exposure data from the DELTA 2 trial were presented as an e-poster. The data was based on an investigation into the systemic exposure of twice-daily delgocitinib cream under high use conditions in the phase 3 DELTA 2 trial in adults with moderate to severe CHE.²

Additionally, the systemic exposure from the DELTA 2 trial was compared with adult pharmacokinetics (PK) data from a phase 1 trial in patients with moderate to severe AD, and with oral administration using the lowest dose tested in an oral PK study in healthy adults.²

Additional details of the data presented at the meeting are provided below:

• “Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe Chronic Hand Eczema
  Author: April W Armstrong
  S028 - Late-breaking Research: Session 1: Saturday, March 8| 9:00 AM - 12:00 PM
  Location: Chapin Theater - Level III

• Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of Chronic Hand Eczema
  Author: Melinda Gooderham
  Poster ID: 62192

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 the cream vehicle in the treatment of adults with moderate to severe CHE.^3-5

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).^3-5

Key secondary endpoints at Week 16 included a 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.^3-5

Subjects who completed 16 weeks of treatment with delgocitinib cream or the cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 Open-label, Multi-site Extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.⁶

About Delgocitinib Cream

Delgocitinib cream is currently under investigation in the United States and other markets. Delgocitinib creamis currently approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates under the brand name Anzupgo^®for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate.

Delgocitinibcream 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.⁷ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁸

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 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.^9,10 HE is the most common skin disorder of the hands¹¹ with a prevalence rate of approximately 4.7%.¹² In a substantial number of patients, HE can develop into a chronic condition.¹¹ 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.¹³

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹⁴ 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.¹⁵ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁶

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

References

1. Armstrong AW, Bernier C, Bissonnette R et al. “Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe Chronic Hand Eczema. Presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting. Orlando, Florida. 7-11 March. Late-Breaking Research Session 1.
2. Gooderham M, Eichenfield LF, Bunick CG et. al. Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of Chronic Hand Eczema. Presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting. Orlando, Florida. 7-11 March. E-poster.
3. 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.
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. 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
6. 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
7. 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.
8. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
9. 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.
10. 14. 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.
11. 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.
12. 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.
13. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
14. 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.
15. 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.
16. 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-80380 MARCH 2025

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