-LEO Pharma A/S, a global leader in medical dermatology, today announced 16-week results of a 52-week monotherapy trial showing tralokinumab significantly improved primary and secondary measurements of efficacy among adolescents (aged 12 to 17) with moderate-to-severe atopic dermatitis.¹?The week 16 results from the Phase 3 ECZTRA 6?trial were shared during the 2021 Fall Clinical Dermatology Conference held virtually and with a hybrid option in Las Vegas.

?These findings are encouraging, as moderate-to-severe atopic dermatitis can have major physical and psychosocial impacts on adolescents who have limited options for long-term treatment.?

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Tralokinumab is a high-affinity, human monoclonal antibody that specifically binds to and inhibits IL-13, a key driver of atopic dermatitis signs and symptoms.^2,3?It is an investigational therapy in clinical development in the United States and has not been approved by the U.S. Food and Drug Administration. It has been approved for the treatment of adults with moderate-to-severe atopic dermatitis by the European Commission and the MHRA in June 2021 and by Health Canada in October 2021. ?After 16 weeks, adolescents who received either dose of tralokinumab, without rescue therapy, showed significantly greater improvement in atopic dermatitis signs and symptoms and quality of life compared to those receiving placebo,? said Amy Paller, M.D., Chair, Department of Dermatology, Feinberg School of Medicine, Northwestern University in Chicago, Illinois, and the international coordinating investigator for ECZTRA 6. ?These findings are encouraging, as moderate-to-severe atopic dermatitis can have major physical and psychosocial impacts on adolescents who have limited options for long-term treatment.? The 16-week initial treatment period of the ECZTRA 6 trial (NCT03526861) assessed the efficacy and safety of tralokinumab 150 mg (n=98) or 300 mg (n=97) every two weeks (Q2W) compared to placebo (n=94) in adolescents.¹?At week 16, tralokinumab met its primary and secondary endpoints, showing significantly more patients treated with tralokinumab achieved a clinical response, compared to placebo, defined as achieving an IGA 0/1 and/or an EASI-75¹:

• 21.4% (p<0.001) of the tralokinumab 150 mg group and 17.5% (p=0.002) of the tralokinumab 300 mg group achieved clear or almost-clear skin compared to 4.3% with placebo as measured by IGA.¹
• 28.6% (p<0.001) of the tralokinumab 150 mg group and 27.8% (p=0.001) of the tralokinumab 300 mg group achieved 75% or greater disease improvement from baseline compared to 6.4% with placebo as measured by EASI.¹

Secondary endpoints were all met, addressing extent and severity of atopic dermatitis (SCORAD), achieving at least a 4-point improvement in adolescent weekly average worst daily pruritus NRS score and health-related quality of life related to dermatological conditions (CDLQI).¹ The safety and tolerability of tralokinumab compared with placebo, when used to treat adolescents with moderate-to-severe atopic dermatitis, was also investigated. The overall frequency and severity of adverse events (AEs) in the trial were comparable across the treatment groups over 16 weeks (67% for tralokinumab 150 mg, 65% for tralokinumab 300 mg, and 62% for placebo).¹ The percentage of AEs, serious AEs, and AEs leading to discontinuation and conjunctivitis events were similar between both doses of tralokinumab (150 mg and 300 mg) and placebo treatment groups in the initial treatment period of 16 weeks. Most AEs in the three treatment groups were mild or moderate in severity and subjects recovered from most. The safety results were consistent with the Phase 3 adult tralokinumab trials.¹ ?We are encouraged by these results that advance our understanding of tralokinumab in adolescents, many of whom often struggle with the negative emotional and physical impacts of atopic dermatitis,? said J?rg M?ller, M.D., Executive Vice President, Global Research and Development, LEO Pharma. ?This is an important milestone for the overall ECZTRA clinical trial program as we expand studies to include younger patients.? To view the full presentation, please visit?https://www.leopharmaposters.net/fall-clinical-dermatology-2021/postercollection211008. About the ECZTRA 6 Trial ECZTRA 6?(ECZema TRAlokinumab trial No. 6, NCT03526861) is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, including a total of 301 patients (aged 12 to 17), with 289 (195 tralokinumab patients and 94 placebo patients) in the full analysis set, evaluating the efficacy and safety of tralokinumab (150 mg or 300 mg) as a monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.^1,4 Following a washout period, patients were randomized to subcutaneous tralokinumab 150 mg or 300 mg Q2W or placebo for an initial 16 weeks. Tralokinumab dosing started with a 300 mg or 600 mg loading dose on day 0 for those receiving tralokinumab 150 mg or 300 mg Q2W, respectively.¹ At week 16, patients who responded to tralokinumab with an IGA score of 0/1 and/or EASI change of at least 75% from baseline, without use of rescue treatment, were re-randomized to tralokinumab Q2W or Q4W for an additional 36 weeks. Patients not achieving primary endpoints at week 16, those receiving rescue treatment from week 2 to week 16, and those meeting other specific criteria were transferred to open-label treatment of tralokinumab 300 mg Q2W plus optional mild-to-moderate strength topical corticosteroids.¹ About atopic dermatitis Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.⁵?Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁶?Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.² 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 majority 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 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information, please visit?www.LEO-Pharma.com. References

1. Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. Fall Clinical. Oct. 21-24, 2021. Poster Presentation.
2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis.?Allergy. 2020; 75:54-62.
3. Popovic B, et al.?Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Ra1 and IL-13Ra2.?J Mol Biol. 2017; 429:208?19.
4. ClinicalTrials.gov. Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).?https://clinicaltrials.gov/ct2/show/NCT03526861
5. Weidinger S, et al. Atopic dermatitis.?Lancet.?2016; 387:1109-1122.
6. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation.?Immunol Rev.?2011;242(1):233-46.

October 2021 MAT-50736