LEO Pharma

LEO Pharma to present new data in moderate-to-severe atopic dermatitis and chronic hand eczema at the 31st EADV Congress

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• Data presentations to cover findings relevant to the long-term safety and efficacy profile for Adtralza® (tralokinumab) in the treatment of moderate-to-severe atopic dermatitis1,2,3 • Studies on delgocitinib and clinical and patient-reported outcomes to provide insight into this investigational treatment for chronic hand eczema4,5

BALLERUP, Denmark, August 25, 2022 – LEO Pharma A/S, a global leader in medical dermatology, will present new data and insights in moderate-to-severe atopic dermatitis and chronic hand eczema at the upcoming 31st European Academy of Dermatology and Venereology (EADV) Congress, September 7 – 10, 2022 in Milan.

Data presentations will share findings into Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents (aged 12-17) and delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adult patients with moderate-to-severe chronic hand eczema (CHE). Adtralza is not approved for use in adolescents aged 12 to 17 years.

Additionally, LEO Pharma will present two symposia pertaining to atopic dermatitis and chronic hand eczema.

“We look forward to sharing our latest findings and amplifying expert perspectives in moderate-to-severe atopic dermatitis and chronic hand eczema,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma A/S. “We remain committed to advancing the standard of care for eczema patients and their families.”

The company’s full roster of accepted presentations and symposia at the 31st EADV Congress includes:

Adtralza® (tralokinumab)

  • 3 years of tralokinumab treatment provides long-term disease control as demonstrated by clinically meaningful outcomes in moderate-to-severe atopic dermatitis

Author: Richard B. Warren

Abstract #: 2299

E-Poster Presentation

  • Tralokinumab demonstrated a consistent safety profile with up to 42-months of treatment in moderate-to-severe atopic dermatitis: including adverse events of special interest

Author: Kristian Reich

Abstract #: 2307

Oral Presentation

Thursday, September 8, from 14.15 – 15.45 CET

  • Safety of tralokinumab in paediatric patients aged 12-17 with moderate-to-severe atopic dermatitis: results from the phase 3 ECZTRA 6 trial

Author: Andreas Wollenberg

Abstract #: 896

Oral Presentation

Thursday, September 8, from 10.15 – 11.45 CET

 

Delgocitinib

  • Time to treatment response in clinical and patient-reported outcome measures from 16-week trial with delgocitinib cream 20 mg/g in patients with chronic hand eczema (CHE)

Author: Tove Agner

Abstract #: 0195

E-Poster Presentation

  • Patient-reported itch and pain are correlated with clinician assessed outcomes in chronic hand eczema (CHE)

Author: Margitta Worm

Abstract #: 0194

E-Poster Presentation

 

Symposia

  • Changing the future for chronic hand eczema patients: Is it in our hands?

Thursday, September 8 from 18.00 – 19.30 CET in theAmber Room 1-2

  • Long-term perspectives in atopic dermatitis

Friday, September 9 from 13.00 – 14.00 CET in theAmber Room 1-2

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About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.8 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.9 Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.10

About 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 HE is the most common skin disorder of the hands13 that affects an estimated 1 – 5% of the general population14 with a one-year prevalence rate of approximately 9%.15 It is an inflammatory, non-infectious skin disorder of the hands and wrists11,16 and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.11,13,17 In a substantial number of patients, HE can develop into a chronic condition.13

About Adtralza® (tralokinumab)

Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine6, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.7,10 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).6,10

 Adtralza is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland.7 It also is approved in the U.S. under the tradename AdbryTM (tralokinumab-ldrm).

About delgocitinib

Delgocitinib is an 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.18,19 LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate-to-severe chronic hand eczema (CHE) in adult patients. The cream formulation of delgocitinib is an investigational therapy under clinical development and has not been approved by any regulatory authority.

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.

References

  1. Warren R, et al. 3 years of tralokinumab treatment provides long-term disease control as demonstrated by clinically meaningful outcomes in moderate-to-severe atopic dermatitis. Presented at European Academy of Dermatology and Venereology (EADV) 2022 Annual Meeting, Milan, Italy, September 7-10, 2022. Poster Presentation #P0333.
  2. Reich K, et al. Tralokinumab demonstrated a consistent safety profile with up to 42 months of treatment in moderate-to-severe atopic dermatitis: including adverse events of special interest. Presented at 31st EADV Congress, Milan, Italy, September 7-10, 2022. Oral Presentation #FC03.
  3. Wollenberg A, et al. Safety of tralokinumab in paediatric patients aged 12-17 with moderate-to-severe atopic dermatitis: results from the phase 3 ECZTRA 6 trial. Presented at European Academy of Dermatology and Venereology (EADV) 2022 Annual Meeting, Milan, Italy, September 7-10, 2022. Oral Presentation #FC02.
  4. Worm M, et al. Time to treatment response in clinical and patient-reported outcome measures from 16-week trial with delgocitinib cream 20 mg/g in patients with chronic hand eczema (CHE). Presented at European Academy of Dermatology and Venereology (EADV) 2022 Annual Meeting, Milan, Italy, September 7-10, 2022. Poster Presentation #P0195.
  5. Agner T, et al. Patient-reported itch and pain correlated with clinician-assessed outcomes in chronic hand eczema (CHE). Presented at European Academy of Dermatology and Venereology (EADV) 2022 Annual Meeting, Milan, Italy, September 7-10, 2022. Poster Presentation #P0194.
  6. Popovic B, 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; 429:208–19.
  7. Adtralza® (tralokinumab) EU Product Information. LEO Pharma; June 2021.
  8. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
  9. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
  10. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
  11. Lynde C, et al. Canadian Hand Dermatitis Management Guidelines. J Cutan Med Surg. 2010;14:267–84.
  12. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. doi: 10.1111/ddg.12510_1.
  13. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
  14. Christoffers WA, et al. Interventions for hand eczema. Cochrane Database Syst Rev. 2019;4:CD004055.
  15. Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.
  16. Menné T, et al. Hand eczema guidelines based on the Danish guidelines for the diagnosis and treatment of hand eczema. Contact Dermatitis. 2011;65:3–12.
  17. Politiek K, et al. Systematic review of cost-of-illness studies in hand eczema. Contact Dermatitis. 2016;75:67–76.
  18. 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.
  19. Virtanen AT, et al. Selective JAKinhibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019;33:15–32.

Contacts

Contact:
David Patti
LEO Pharma, Global Product Communications
973.796.7706
DAPAI@leo-pharma.com

Jes Broe Frederiksen
LEO Pharma, Global Communications Manager
+45 53 60 59 48
JEBFE@leo-pharma.com

About LEO Pharma

LEO Pharma
LEO Pharma
Industriparken 55
2750 Ballerup

4494 5888http://www.leo-pharma.com/

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 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

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Latest releases from LEO Pharma

LEO Pharma announces positive phase 3 topline results from DELTA 1 trial with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE)6.12.2022 08:00:00 CET | Press release

• The first phase 3 clinical trial (DELTA 1) with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE) met primary and all key secondary endpoints • DELTA 1 trial results show that delgocitinib cream provided early symptom-relief in a hard-to-treat disease • The majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related

LEO PHARMA LAUNCHES AD DAYS AROUND THE WORLD CAMPAIGN TO RAISE AWARENESS OF THE IMPACT OF ATOPIC DERMATITIS ACROSS CULTURES3.10.2022 07:00:00 CEST | Press release

• In partnership with Global patient advocate Ashley Ann Lora, AD Days Around the World explores the impact of atopic dermatitis (AD) on the lives of individuals around the world living with this chronic and debilitating skin disease • The campaign features the emotional journey of four patient advocates from France, Italy, Germany and Spain and showcases the impact that AD has on people, regardless of culture or geography

LEO Pharma and DKSH Partner to Deliver Products and Solutions to People in Asia with Skin Conditions and Thrombosis29.9.2022 07:00:00 CEST | Press release

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LEO Pharma presents new Adtralza® safety data in moderate-to-severe atopic dermatitis at the 31st EADV Congress8.9.2022 14:15:00 CEST | Press release

• An interim safety analysis from ECZTEND, an open-label, 5-year extension trial, demonstrated consistent safety from the parent trials for up to 3.5 years of Adtralza® (tralokinumab) treatment in adult patients with moderate-to-severe atopic dermatitis.1 • Exposure-adjusted incidence rates of adverse events of special interest, including conjunctivitis, eczema herpeticum, and skin infections requiring systemic treatment, were generally lower than rates reported during the placebo-controlled period up to Week 16 and declined over time.1

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