LEO Pharma has 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, which plays an important role in the development of moderate-to-severe atopic dermatitis. Tralokinumab is not currently licensed in any indication.
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.”
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.