LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE)

• Delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules as its primary outcome measure.
• Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, health-related quality of life (HRQoL), and a lower number of treatment-emergent adverse events.
• DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.¹
• With only one treatment option currently approved for severe CHE and no approved options for more moderate forms of the disease, there is a considerable unmet need for patients living with CHE.

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.

DELTA FORCE is a head-to-head trial in adult participants with severe chronic hand eczema (CHE) comparing a potential new topical treatment with a systemic treatment.¹ It is a phase 3, two-arm trial (N=513) that compares the efficacy and safety of delgocitinib cream with alitretinoin capsules.¹ Alitretinoin is the only treatment currently approved to specifically treat severe CHE in patients who do not respond to topical corticosteroids.² Delgocitinib cream is currently under investigation and is not yet approved for use by any health authority.

Delgocitinib cream achieved the primary outcome measure of the trial by demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules.

Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, a reduction in HECSI score from baseline to Week 24, and a significant improvement in health-related quality of life (HRQoL), as measured by the Dermatology Life Quality Index (DLQI).

Furthermore, patients receiving delgocitinib cream had a lower number of treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules. No specific treatment-emergent safety concerns were identified for delgocitinib cream, and the overall safety profile was consistent with what was observed in DELTA 1, 2 and 3.

“Currently, there is only one specific treatment option available for those living with severe CHE. We are confident that with the DELTA FORCE study, delgocitinib cream may play a crucial role in expanding the options available for patients in this hard-to-treat condition,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.

“Our hands are integral to everything we do. I have heard countless stories from patients about just how much this condition impacts their everyday lives socially, psychologically and physically. CHE often limits their ability to work,” said Alexander Egeberg, Head of Global Medical Affairs, LEO Pharma. “With such a considerable unmet need for patients living with CHE, we are proud to have conducted this study, which we hope can drive forward a potential new treatment option with delgocitinib cream”.

Further data analyses will be conducted to determine any additional potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.

For more information on the DELTA FORCE trial (NCT05259722) go to clinicaltrials.gov.

About the DELTA FORCE Trial

DELTA FORCE was a 24-week, randomised, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.¹

The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.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.^3,4 HE is the most common skin disorder of the hands⁵ with a one-year prevalence rate of approximately 9%.⁶ In a substantial number of patients, HE can develop into a chronic condition.⁵ 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.²

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,⁷ 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.⁸ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.⁹

About delgocitinib

Delgocitinib cream is an investigational, 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.¹⁰ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹¹ 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 4,400 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://classic.clinicaltrials.gov/ct2/show/NCT05259722.
2. Thyssen JP, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis 2022;86:357–378.
3. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
4. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
5. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
6. Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.
7. 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.
8. 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.
9. 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.
10. 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.
11. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema.Dermatol Ther. 2019;32(3):e12840.

MAT-70862 January 2024

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