LEO Pharma has announced that its experimental atopic dermatitis therapy, tralokinumab, has met all its primary and secondary endpoints in the ECZTRA 1, 2 and 3 Phase III trials.
The drug, indicated for moderate-to-severe versions of the disease, demonstrated clear or almost clear skin at week 16 and at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16. In addition, it showed a change in baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD) and overall adverse event rate was comparable to placebo.
The investigational, fully human monoclonal antibody works by specifically neutralising the interleukin-13 (IL-13) cytokine; a key driver of the type II inflammation that plays a major role in atopic dermatitis.
“In its moderate-to-severe form, atopic dermatitis can cause unbearable recurring symptoms for patients,” said Dr Kim Kjoeller, executive vice president, global research & development, LEO Pharma. “Despite recent treatment advances, we consistently hear from healthcare professionals around the world that additional treatment options are needed to address the different signs and symptoms for each patient.
“We are encouraged by these study results, which show that tralokinumab could be an efficacious and well-tolerated long-term treatment solution for patients living with this debilitating chronic skin disease.”
On the news, LEO Pharma plans to submit marketing authorisation applications for the drug to regulatory agencies in 2020, as well as planning to submit the detailed results of these studies for presentation at scientific congresses and publication in peer-reviewed medical journals.