LEO Pharma announces positive results of Phase 2b dose-finding study with delgocitinib cream in adult patients with mild-to-severe chronic hand eczema (CHE)

Results were presented during the Late-Breaking News session of the

European Academy of Dermatology and Venereology (EADV) Virtual 2020

BALLERUP, Denmark & MADISON, N.J.--(BUSINESS WIRE)--NOT FOR USE IN THE UK OR IRELAND

EMBARGOED UNTIL OCTOBER 29, 2020 4:00 pm CET

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of a Phase 2b dose-finding study with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, during the Late Breaking News session of the European Academy of Dermatology and Venereology (EADV) Virtual 2020.¹

Delgocitinib 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.^2,3 The cream formulation of delgocitinib is an investigational therapy under clinical development and has not been approved by any regulatory authority.

The primary endpoint for the randomized, double-blind, vehicle-controlled, multi-center Phase 2b dose-finding trial was the proportion of adult patients with mild-to-severe CHE who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) or 1 (almost clear) with a ≥2 point improvement from baseline, at week 16.¹ A key secondary endpoint was change in Hand Eczema Severity Index (HECSI) from baseline to week 16.¹

The results presented today showed that delgocitinib cream demonstrated a statistically significant dose-response relationship for these endpoints compared to vehicle.¹ Across all treatment groups, the majority of adverse events were non-serious, mild or moderate in severity and not considered treatment related.¹ In addition, none of the three serious adverse events were considered treatment related,¹ and the most frequently reported adverse events were nasopharyngitis, eczema and headache.¹

"There is a significant unmet need for additional treatments for long-term control of CHE, which can cause considerable social and employment burden for both individuals and society,” said Prof. Margitta Worm, Division of Allergy and Immunology, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin. “The results of this trial showed that delgocitinib cream may have the potential to become a new treatment option for adult patients suffering from mild-to-severe CHE.”

CHE is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.^4,5 HE is the most common skin disorder of the hands⁶ that affects an estimated 1 – 5% of the general population⁷ with a one-year prevalence rate of approximately 10%.⁸ It is an inflammatory, non-infectious skin disorder of the hands and wrists^4,9 and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.^4,6,10 In a substantial number of patients, HE can develop into a chronic condition.⁶

#ENDS#

About Delgocitinib

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.

Earlier this year, delgocitinib cream received Fast Track designation for the treatment of moderate-to-severe CHE from the U.S. Food and Drug Administration. The Fast Track process facilitates the development and expedites regulatory review of drugs to treat serious conditions and that demonstrate the potential to address an unmet medical need.¹¹

About LEO Pharma

The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit www.leo-pharma.com.

References

---

¹ Worm M, et al. The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema. Presented during the Late Breaking News session of the European Academy of Dermatology and Venereology (EADV) Virtual 2020 on 29 October 2020.

² Damsky W, and King BA. JAAD; 2017;76(4):736-744.

³ Virtanen AT, et al. BioDrugs. 2019;33:15–32.

⁴ Lynde C, et al. J Cutan Med Surg. 2010;14:267–84.

⁵ Diepgen TL, et al. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. doi: 10.1111/ddg.12510_1.

⁶ Bissonnette R, et al. JEADV. 2010;24;1–20.

⁷ Christoffers WA, et al. Cochrane Database Syst Rev. 2019;4:CD004055.

⁸ Thyssen et al. Contact Dermatitis. 2010;62:75-87.

⁹ Menné T, et al. Contact Dermatitis. 2011;65:3–12.

¹⁰ Politiek K, et al. Contact Dermatitis. 2016;75:67–76.

¹¹ U.S. Food and Drug Administration. Fast Track: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (Accessed October 2020).