LEO Pharma Starts Phase 3 Clinical Study for Tralokinumab in Atopic Dermatitis

Ballerup, Denmark (ots/PRNewswire) -

LEO Pharma today announced that the first patients have been dosed
in a phase 3 clinical study of tralokinumab. Tralokinumab is an
investigational human monoclonal antibody that specifically targets
the cytokine IL-13[1], which plays an important role in the
development of moderate-to-severe atopic dermatitis[2]. Tralokinumab
is not currently licensed in any indication.

(Logo: http://photos.prnewswire.com/prnh/20130221/595427 )

ECZTRA 1, the first clinical study in the phase 3 clinical
programme for tralokinumab in atopic dermatitis, is a randomised,
double-blind, placebo-controlled, phase 3 trial to evaluate the
efficacy and safety of tralokinumab monotherapy in patients with
moderate to severe atopic dermatitis who are candidates for systemic
therapy.

"Moderate to severe atopic dermatitis is a debilitating skin
condition characterised by intense itching, painful skin lesions, and
infections. Advancements in the treatment of this underserved
condition are necessary," said Dr. Eric Simpson, ICI, Professor and
Director of Clinical Trials at the Oregon Health and Science
University, Department of Dermatology. "In this phase 3 programme we
will establish how tralokinumab's specific targeting of IL-13 might
offer a potential new treatment for patients with this complex and
chronic disease."

"Eczema patients are in need of new treatment options," said Julie
Block, President & CEO, National Eczema Association, USA. "This is a
disease with a significant impact on patients' quality of life, and
we welcome LEO Pharma's investment in new clinical approaches."

Further information about the trial will be available at
https://clinicaltrials.gov

The development of tralokinumab is part of LEO Pharma's recent
move into systemic treatments for skin diseases. In July 2016, LEO
Pharma acquired the global licence to tralokinumab in skin diseases
from AstraZeneca, as well as the exclusive European licence to
develop and commercialise brodalumab, an IL-17 receptor monoclonal
antibody, for the treatment of moderate-to-severe plague psoriasis.
LEO Pharma has partnerships on biologic treatments with AstraZeneca,
argenx, and MorphoSys, and a total of six biologic projects in its
R&D pipeline.

About Atopic Dermatitis

Atopic dermatitis, also known as atopic eczema, is a serious and
chronic form of eczema. It is the most common inflammatory skin
disease with prevalence in western countries of 1-3% in adults and up
to 20% in children[3],[4]. The severity of atopic dermatitis can be
categorised into mild, moderate and severe. The moderate and severe
forms constitute approximately 50% and 20%, respectively, of the
atopic dermatitis patient pool in a US population-based survey[5].
Atopic dermatitis may, in its moderate to severe form, be a
debilitating condition that can be characterised by intense itching,
painful skin lesions, and skin infections witch may significantly
impact quality of life[6]. There is currently a high unmet need for
long-term efficacious and well-tolerated treatment options in atopic
dermatitis[7].

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care
solutions to patients in more than 100 countries globally, LEO Pharma
supports people in managing their skin conditions. Founded in 1908
and owned by the LEO Foundation, the healthcare company has devoted
decades of research and development to delivering products and
solutions to people with skin conditions. LEO Pharma is headquartered
in Denmark and employs around 5,000 people worldwide.

References

1. Popovic B, Breed J, Rees DG, Gardener MJ, Vinall LM, Kemp B et
al. Structural Characterisation Reveals Mechanism of
IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of
Binding to IL-13Ralpha1 and IL-13Ralpha2. J Mol Biol
2017;429(2):208-219.

2. Brandt EB, Sivaprasad U. Th2 Cytokines and Atopic Dermatitis. J
Clin Cell Immunol 2011;2(3).

3. Ring J, Alomar A, Bieber T, Deleuran M, Fink-Wagner A, Gelmetti
C et al. Guidelines for treatment of atopic eczema (atopic
dermatitis) part I. J Eur Acad Dermatol Venereol
2012;26(8):1045-1060.

4. Wollenberg A, Oranje A, Deleuran M, Simon D, Szalai Z, Kunz B
et al. ETFAD/EADV Eczema task force 2015 position paper on diagnosis
and treatment of atopic dermatitis in adult and paediatric patients.
J Eur Acad Dermatol Venereol 2016;30(5):729-747.

5. Hanifin JM, Reed ML. A population-based survey of eczema
prevalence in the United States. Dermatitis 2007;18(2):82-91.

6. Lifschitz C. The impact of atopic dermatitis on quality of
life. Ann Nutr Metab 2015;66 Suppl 134-40.

7. Q&A with Dr. Silverberg. Ask the Presenter - Conference Report.
AJMC 2016

ots Originaltext: LEO Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Henrik Heskjaer Kyndlev
henrik.kyndlev@leo-pharma.com
Tel +45 3140 6180

Original-Content von: LEO Pharma, übermittelt durch news aktuell