LEO Pharma announces positive top-line results for tralokinumab from three Phase 3 studies in adult patients with moderate-to-severe AD

LEO Pharma A/S, a global leader in medical dermatology, today announced that tralokinumab ? an investigational, fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine ? met all primary and secondary endpoints in its three pivotal Phase 3 studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo.

IL-13 is a key driver of the type 2 inflammation that plays a major role in AD,¹ which is the most common inflammatory skin disease in the developed world,² affecting up to five percent of adults across the United States, Canada, Europe and Japan.³ AD can have a significant, negative impact on patients' well-being, primarily due to distressing itch, sleep deprivation and social stigmatization due to visible lesions.⁴

"In its moderate-to-severe form, AD can cause unbearable recurring symptoms for patients," said Dr Kim Kjoeller, Executive Vice President, Global Research & Development, LEO Pharma. "Despite recent treatment advances, we consistently hear from healthcare professionals around the world that additional treatment options are needed to address the different signs and symptoms for each patient. We are encouraged by these study results, which show that tralokinumab could be an efficacious and well-tolerated long-term treatment solution for patients living with this debilitating chronic skin disease."

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab studies no. 1 and 2), are randomized, double-blind, placebo-controlled, multinational, 52-week studies, which included 802 and 794 adult patients respectively, to evaluate the efficacy and safety of tralokinumab as monotherapy in adults with moderate-to-severe AD who are candidates for systemic therapy. ECZTRA 3 is a randomized, double-blind, placebo-controlled, multinational 32-week study, which included 380 adult patients, to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who are candidates for systemic therapy.

The primary endpoints in the three studies were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin at week 16 and at least a 75 percent or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16. A change from baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI) were secondary endpoints.

LEO Pharma is planning to submit marketing authorization applications for tralokinumab for the treatment of adult patients with moderate-to-severe AD to regulatory agencies in 2020 and plans to submit the detailed results of these studies for presentation at scientific congresses and publication in peer-reviewed medical journals in 2020 as well. Further information about trials with tralokinumab can be accessed at https://clinicaltrials.gov.

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NOTES TO EDITORS

About atopic dermatitis
Atopic dermatitis (AD) is a chronic, relapsing skin disease, characterized by severe itch, dry skin, persistent immune-mediated inflammation, and skin barrier defects.⁵ AD is a result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁶ Type-2 cytokines, such as IL-13 and IL-4, play a central role in the key aspects of AD pathophysiology.⁷ Due to the immune dysregulation, IL-13 is overexpressed in lesional and non-lesional skin.^8,9

About tralokinumab
Tralokinumab is an investigational agent under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. Tralokinumab is a fully human, immunoglobulin (Ig)G4 monoclonal antibody (mAb) that works by neutralizing the IL-13 cytokine. IL-13 plays a key role in the pathophysiology of AD.¹⁰ By specifically binding to the IL-13 cytokine, tralokinumab prevents its interaction with the receptor and the subsequent downstream IL-13 signalling.¹¹

About LEO Pharma
LEO Pharma helps people achieve healthy skin. 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 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million. For more information about LEO Pharma, visit www.leo-pharma.com.

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¹¹ Popovic B et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13R?1 and IL-13R?2. J Mol Biol. 2017;429:208-219.