LEO Pharma showcases data in four disease areas at 2019 American Academy of Dermatology Annual Meeting in Washington, D.C.

BALLERUP, Denmark, 1 March 2019 – LEO Pharma A/S, a global leader in medical dermatology, today announced that 13 data abstracts, including seven oral presentations across atopic dermatitis (AD), chronic hand eczema, psoriasis and actinic keratosis will be presented during the 2019 American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C., starting today.

"We are motivated by the potential of the findings being presented at AAD this year, for example within atopic dermatitis, where our data show that the treatment of moderate-to-severe AD with tralokinumab led to reduced Staphylococcus aureus skin colonization and inflammatory biomarkers, as well as a clear improvement in clinical symptoms," said Kim Domela Kjøller, EVP of Global R&D at LEO Pharma A/S. "In plaque psoriasis, further data from our comprehensive clinical trial program for calcipotriene/betamethasone dipropionate foam demonstrate efficacy in reducing disease severity in adults and extend our understanding of its safety in adolescents. We are proud to be advancing the science in atopic dermatitis, psoriasis and other skin diseases for the ultimate good of patients globally."

E-posters will be accessible online starting at 7 a.m. EST today. Meeting attendees may also visit the e-poster viewing stations in the AAD Connection, located in Hall D in the Walter E. Washington Convention Center, during regular exhibit hours. Oral presentations will take place in Hall D according to the posted schedule.

Tralokinumab in atopic dermatitis and atopic dermatitis abstracts

Title

Lead Author and/or Presenter

Presentation

Poster Number

Tralokinumab, an anti-interleukin-13 monoclonal antibody, reduces Staphylococcus aureus colonization of the skin and systemic levels of inflammatory biomarkers in atopic dermatitis patients

J.I. Silverberg

E-poster and oral:

Friday, March 1, 1:00 - 1:05 p.m.

Location: E-poster Presentation Center 2

8690

Qualitative patient research to support the development of a conceptual model to illustrate the patient experience of atopic dermatitis in adults

C. Trennery

E-poster

10199

Qualitative patient research to support the development of a conceptual model to illustrate the experience of atopic dermatitis in adolescents

N. Kragh

E-poster and oral:

Saturday, March 2, 9:25 - 9:30 a.m.

Location: E-poster Presentation Center 1

10000

 

Delgocitinib abstract in chronic hand eczema

Title

Lead Author and/or Presenter

Presentation

Poster Number

Topical delgocitinib is an efficacious and well tolerated treatment for patients with chronic hand eczema

S. Molin

E-poster and oral: Friday, March 1,
1:25 - 1:30 p.m. Location: E-poster Presentation Center 2

8467

 

*Brodalumab abstract in psoriasis

Title

Lead Author and/or Presenter

Presentation

Poster Number

Brodalumab in psoriatic arthritis (PsA): 24-week results from the phase III AMVISION-1 and -2 trials

K. Hjuler

E-poster and oral:

Friday, March 1, 12:00 – 12:05 p.m. Location: E-poster Presentation Center 1

10139

 

Calcipotriene/betamethasone dipropionate abstracts in psoriasis

Title

Lead Author and/or Presenter

Presentation

Poster Number

Effect of fixed combination calcipotriene plus betamethasone dipropionate foam on lesion quality in patients with plaque psoriasis: data from the PSO-FAST study

K. Veverka

E-poster

9750

PGAxBSA composite versus mPASI: comparison of efficacy response for Cal/BD Foam across mild, moderate and severe plaque psoriasis

L. Stein Gold

E-poster

8357

Improvements in efficacy and lesion quality in scalp plaque psoriasis with fixed combination calcipotriene and betamethasone dipropionate (Cal/BD) foam treatment

D. S. Patel

E-poster and oral:

Sunday, March 3, 11:40 - 11:45 a.m.

Location: E-poster Presentation Center 2

9803

Improvements of both inflammation and skin barrier in a human Th17 skin inflammation model by topical treatment with fixed-dose combination calcipotriene/betamethasone dipropionate foam

H. Norsgaard

E-poster and oral:

Saturday, March 2, 12:20 - 12:25 p.m.

Location: E-poster Presentation Center 2

10086

Efficacy of fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam in adolescent patients with psoriasis: results from a Phase 2 trial

M. Liljedahl

E-poster

10044

Safety of fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam in adolescent patients with psoriasis: results from a Phase 2 trial

M. Liljedahl

E-poster

10061

 

Ingenol mebutate abstracts in actinic keratosis

Title

Lead Author and/or Presenter

Presentation

Poster Number

Safety and efficacy of Ingenol Mebutate gel 0.015%, for the treatment of actinic keratoses on the face in solid organ transplant recipients

L. D. Crow

E-poster

8289

Real world safe and effective use of cryotherapy and field directed treatment for the different severities of actinic keratosis

S. Feldman

E-poster and oral:

Friday, March 1, 10:10 - 10:15 a.m.

Location: E-poster Presentation Center 2

9716

 

For more information about the 2019 AAD Annual Meeting in Washington, D.C., please visit https://www.aad.org/meetings/annual-meeting.


- ENDS-
 


NOTES TO EDITORS

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.[i]  Tralokinumab specifically and directly binds to the IL-13 cytokine, preventing its interaction with the IL-13 receptor α1 and α2.[ii] In a 12-week phase 2b study, tralokinumab and concomitant topical glucocorticoids demonstrated meaningful improvements across clinical and patient-reported outcomes.[iii]

 

About delgocitinib

Delgocitinib is an investigational agent under clinical development and its safety and efficacy have not been evaluated by any regulatory authority. Elevated levels of various cytokines are involved in the disease process of inflammatory diseases.[iv] Topical delgocitinib is a pan-JAK inhibitor, which blocks various cytokine signalling pathways and widely suppresses the activation of immune and inflammatory cells such as T cells, B cells, mast cells and monocytes.

In 2014, LEO Pharma 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 brodalumab

Brodalumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults within the European Union who are candidates for systemic therapy. [v] It is the first and only biologic treatment for psoriasis that selectively targets the interleukin-17 (IL-17) receptor subunit A .[vi],[vii] These receptors are the ones through which the IL-17 cytokines – a family of proteins involved in immune responses – signal, causing the inflammation associated with psoriasis.

LEO Pharma has a partnership agreement with AstraZeneca, granting LEO Pharma exclusive license to develop and commercialize brodalumab in Europe. Outside of Europe, Ortho Dermatologics has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co. Ltd.

 

About calcipotriene/betamethasone dipropionate

Calcipotriene/betamethasone dipropionate foam [0.005%/0.064%] is formulated as a fixed-dose combination and, in addition to the ointment and topical suspension formulations, is the first and only once-daily, alcohol-free spray foam for treatment of all severities of adult plaque psoriasis. Calcipotriene/betamethasone dipropionate foam [0.005%/0.064%] is commercially available in the U.S. and several markets globally.

 

About Ingenol mebutate

Ingenol mebutate gel (0.015%, 0.05%), a prescription medicine used to treat actinic keratosis, is a topical, field-directed therapy which is self-administered by the patient to the affected areas of the skin once a day for two or three consecutive days, depending on the treatment location, with efficacy assessed at day 57..[viii]  Ingenol mebutate gel is commercially available in the U.S. and is also available in several other markets across the globe.

 

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 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million. For more information, go to: www.linkedin.com/company/leo-pharma or www.leo-pharma.com

 


[i] Brandt, E.B., Sivaprasad, U. Th2 Cytokines and Atopic Dermatitis.  J Clin Cell Immunol. 2011; 2(3): 1-25. doi:10.4172/2155-9899.1000110.

[ii] 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;429:208-219

[iii] Wollenberg A, et al. Treatment of atopic dermatitis with tralokinumab, an anti–IL-13 monoclonal antibody. J Allergy Clin Immunol 2018; 143: 135 - 141. https://doi.org/10.1016/j.jaci.2018.05.029.

[iv] Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M, O’Shea J. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nature Reviews. 2017; 16: 843-862. doi:10.1038/nrd.2017.201.

[v] European Commission, Community register of medicinal products for human use, Kyntheum® (brodalumab). Available at:  http://ec.europa.eu/health/documents/community-register/html/h1155.htm (Accessed July 2018).

[vi] Campa M, et al. Dermatol Ther 2016;6:1–12.

[vii] Coimbra S, et al. Core Evidence 2014;9:89–97.

[viii] Lebwohl M, et al. N Eng J Med. 2012; 366:1010-9