LEO Pharma Announces Positive Phase 3 Topline Results From DELTA 2 Trial With Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (CHE), Confirming the Positive Results of the Recent DELTA 1 Trial

• The second phase 3 clinical trial (DELTA 2) with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE) met its primary and all key secondary endpoints
• This further validates the positive results of the DELTA 1 phase 3 trial that concluded in 2022, which also met its primary and all key secondary endpoints
• DELTA 2 trial results show that delgocitinib cream provided efficacious treatment and early symptom relief in a hard-to-treat disease¹

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 2 trial. 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).

The trial met its primary endpoint with a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to cream vehicle, and the treatment was well-tolerated. All or most of the signs and symptoms of CHE were cleared early in the treatment period for a significantly larger proportion of patients treated with delgocitinib cream compared to subjects treated with cream vehicle. DELTA 2 is the second phase 3 trial to achieve its primary and all key secondary endpoints, confirming the positive results of the DELTA 1 trial.

"It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA 1 results announced late last year", said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. "CHE is a condition that we know can have a hugely negative impact on patient quality of life, physical functioning, and ability to work. These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease."

Subjects who completed 16 weeks of treatment in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 extension trial to evaluate the long-term effects of delgocitinib cream.²

Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 2 are planned to be submitted for scientific presentation and publication at a later date.

For more information on the DELTA 2 trial (NCT04872101) go to clinicaltrials.gov.

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) is 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.^3,4

The primary endpoint of the trials is the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a two-step improvement from baseline. Additional IGA-CHE scores include 2 (mild), 3 (moderate), and 4 (severe).

Key secondary endpoints at Week 16 include 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 defines 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 roll-over to the DELTA 3 extension trial. The purpose of this extension trial is to evaluate the long-term effects of delgocitinib.²

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.^5,6 HE is the most common skin disorder of the hands⁷ with a one-year prevalence rate of approximately 9%.⁸ In a substantial number of patients, HE can develop into a chronic condition.⁷ 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.⁹

About delgocitinib

Delgocitinib is a first-in-class investigational topical pan-Janus kinase (JAK)-inhibitor that inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.^10,11 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 4,600 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

References

¹ A Elsner P, Agner T. J Eur Acad Dermatol Venereol. 2020;34(Suppl. 1):13–21

² ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04949841 (Accessed Jan 2023).

³ ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04871711 (Accessed Jan 2023).

⁴ ClinicalTrials.Gov:https://clinicaltrials.gov/ct2/show/NCT04872101 (Accessed Jan 2023).

⁵ Lynde C, et al. Canadian Hand Dermatitis Management Guidelines. J Cutan Med Surg. 2010;14:267–84.

⁶ Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.

⁷ Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.

⁸ Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.

⁹ Thyssen JP, et al.2022: Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis 2022;86:357–378;

¹⁰ Damsky W, et al. JAK inhibitors in dermatology: The promise of a new drug class. Journal of American Academy of Dermatology (JAAD); 2017;76(4):736-744.

¹¹ Virtanen AT, et al. Selective JAKinhibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019;33:15–32.

MAT- 63863 February 2023

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