LEO Pharma Presents Adbry® (tralokinumab-ldrm) and Delgocitinib Cream Data at 2024 Fall Clinical Dermatology Conference

• Delgocitinib cream data will include the final results of the Phase 3 head-to-head DELTA FORCE trial,¹ as well as a wide range of findings on delgocitinib cream and moderate to severe chronic hand eczema (CHE).^3-9
• Results from the long-term ECZTEND tralokinumab-ldrm trial identified no new safety signals in adults and adolescent patients (aged 12 years and over with moderate-to-severe atopic dermatitis (AD)) treated for up to 6 years.²
• New data also includes results from the TRACE study on tralokinumab-ldrm in adults with moderate to severe AD on hands and feet, and genitals.¹⁰

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma Inc., a global leader in medical dermatology, will present a comprehensive catalog of new data around investigational delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE) and Adbry^® (tralokinumab-ldrm) in the treatment of patients 12 years of age or older with moderate to severe atopic dermatitis (AD). The findings are being presented across 18 posters at the 2024 Fall Clinical Dermatology Conference taking place from Oct. 24-27 in Las Vegas, Nevada.

Delgocitinib cream is an investigational topical pan-JAK inhibitor for the treatment of adults with moderate-to-severe CHE, who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Presentations on delgocitinib cream will include results from the 24-week DELTA FORCE trial that compared the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE.¹

Tralokinumab-ldrm is marketed in the U.S. as Adbry for patients 12 years of age or older with moderate to severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. New data includes results from the TRACE study on tralokinumab-ldrm in adults with moderate to severe AD on hands and feet, and genitals,¹⁰ as well as results from the long-term ECZTEND tralokinumab-ldrm trial that identified no new safety signals in adults and adolescent patients (aged 12 years and over with moderate-to-severe AD) treated for up to 6 years.²

“We are proud to present new data, which will help further understanding of how to meet the unique needs of patients living with atopic dermatitis and chronic hand eczema,” says Shannon Schneider, LEO Pharma VP Medical Affairs, North America. “The depth of LEO Pharma data being presented at the Fall Clinical Dermatology Conference this year truly showcases our leadership in the medical dermatology space, our commitment to driving innovation and ambition to advance the standard of care for patients.”

Fall Clinical is the latest major dermatology congress in which LEO Pharma has produced a steady flow of industry news. These developments underscore a commitment to advancing scientific innovation and development in medical dermatology, with the aim of making a fundamental difference for people living with challenging skin conditions.

The company’s full roster of accepted presentations at the 2024 Fall Clinical Dermatology Conference includes:

Adbry^® (tralokinumab-ldrm)

• Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years
  Author: Andrew Blauvelt
  E-poster presentation

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with atopic dermatitis with hands and feet involvement after up to 9 months of treatment in the TRACE study
  Author: Diamant Thaçi
  E-Poster presentation

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study
  Author: Elena Pezzolo
  E-poster presentation

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis on the genitals: Interim data on improvements in physician-assessed disease severity and patient-reported outcomes in up to 3 months of treatment in the TRACE study
  Author: Esther Serra-Baldrich
  E-poster presentation

• Anchored matching-adjusted indirect comparison of the long-term maintenance of efficacy of tralokinumab and lebrikizumab in treating moderate-to-severe atopic dermatitis
  Author: Matthias Augustin
  E-poster presentation

• A 1-Year Assessment of Tralokinumab Real-World Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis Adult Patients in the United States
  Author: Peter Lio
  E-poster presentation

• Real-world Q4W Dosing among Atopic Dermatitis (AD) Patients on Tralokinumab: A Claims-based Analysis
  Author: Daniel Butler
  E-poster presentation

• Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis
  Author: Andrew Blauvelt
  E-poster presentation

• Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study
  Author: April Armstrong
  E-poster presentation

• Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis
  Author: Andrew Blauvelt
  E-poster presentation

Delgocitinib Cream

• DELTA FORCE trial: A 24-week Phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe Chronic Hand Eczema
  Author: Ana Maria Giménez-Arnau
  E-poster presentation

• Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema
  Author: David Cohen
  E-poster presentation

• Delgocitinib cream provides early and meaningful responses in adults with moderate to severe Chronic Hand Eczema: a pooled analysis of the phase 3 DELTA-1 and DELTA-2 trials
  Author: JiaDe Yu
  E-poster presentation

• Delgocitinib Cream Leads to Significant Improvements Across All Chronic Hand Eczema Signs and Region HECSI Sub-scores in the Phase 3 DELTA 1 and DELTA 2 Studies
  Author: Benjamin Ehst
  E-poster presentation

• Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the Phase 3 DELTA-1 and -2 trials
  Author: Robert Bissonnette
  E-poster presentation

• Delgocitinib cream reduces itch and pain in adults with moderate to severe chronic hand eczema: pooled analyses of the Phase 3 DELTA-1 and -2 trials
  Author: Andrea Bauer
  E-poster presentation

• Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial
  Author: Melinda Gooderham
  E-poster presentation

• Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe chronic hand eczema in the Phase 3 DELTA-2 trial
  Author: Melinda Gooderham
  E-poster presentation

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

• ADBRY^® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose (150 mg) prefilled syringe with needle guard.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject -too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• Upper respiratory tract infections
• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

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.^11,12 CHE is one of the most common skin disorders of the hands with a prevalence rate of approximately 4.7%.¹³ In a substantial number of patients, HE can develop into a chronic condition.¹⁴ 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.¹⁵

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹⁶ 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.¹⁷ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁸

About atopic dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹⁹ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.²⁰ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.²¹

About delgocitinib cream

Delgocitinib cream is an investigational, 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.²² The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.²² 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 approved in Europe. 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 Adbry^® (tralokinumab-ldrm)

Adbry^® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename Adtralza^® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.²⁰ Tralokinumab-ldrm specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).²³

Tralokinumab-ldrm is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab-ldrm is approved for use in adults with moderate to severe AD in Switzerland and Japan.

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 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

1. Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: A 24-week head-to-head Phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe Chronic Hand Eczema. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
2. Blauvelt, A, Laquer V, Langley, RG et al. Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
3. Yu J, Simpson E, Tsianakas A et al. Delgocitinib cream provides early and meaningful responses in adults with moderate to severe Chronic Hand Eczema: a pooled analysis of the phase 3 DELTA-1 and DELTA-2 trials. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
4. Ehst B, Hong C, Magnolo N et al. Delgocitinib Cream Leads to Improvements Across All Chronic Hand Eczema Signs and Sites of Disease: An Analysis of the HECSI Response in the Phase 3 DELTA 1 and DELTA 2 Studies. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
5. Cohen D, Bewley A, Wollenberg A et al. Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
6. Bissonnette R, Worm R, Warren RB et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the Phase 3 DELTA-1 and -2 trials. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
7. Bauer A, Schuttelaar ML, Baranowski K et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe chronic hand eczema: pooled analyses of the Phase 3 DELTA-1 and -2 trials. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
8. Gooderham M, Molin S, Bissonnette R et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
9. Gooderham M, Thaçi D, Madsen D et al. Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe chronic hand eczema in the Phase 3 DELTA-2 trial. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
10. Armstrong A, Ameen A, Bagel J et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.
11. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
12. Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.
13. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
14. Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.
15. Thyssen JP, Silverberg JI, Guttman-Yassky E. Chronic hand eczema understanding has ramifications on clinical management. J Eur Acad Dermatol Venereol. 2020;34(8):e429-e430.
16. 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.
17. 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.
18. 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.
19. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
20. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.
21. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
22. 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. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. July 18.
23. Popovic B, Breed J, Rees DG, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219.

MAT-77322 October 2024