Anti-OX40 antibody shows efficacy in atopic dermatitis treatment
Kyowa Kirin reported positive phase 2 study results for KHK4083 in treating atopic dermatitis compared with placebo, according to a press release.
The multicenter, randomized, double-blind, placebo-controlled clinical study evaluated the safety and efficacy of KHK4083, an anti-OX40 fully human monoclonal antibody, in 274 patients with moderate to severe atopic dermatitis.
All patients who received the study drug achieved superior results compared with placebo for the primary endpoint of statistically significant changes in Eczema Area and Severity Index scores at 16 weeks. A significant number of those achieving EASI-75 and those achieving an Investigator’s Global Assessment of 0 or 1 with an improvement of two or more points was also recorded in the study group at week 16.
“This adds a very important factor to the treatment paradigm of atopic dermatitis,” lead study investigator Emma Guttman-Yassky, MD, PhD, system chair for the department of dermatology and Waldman Professor of Dermatology and Immunology at the Icahn School of Medicine at Mount Sinai, and director of the Center for Excellence in Eczema and the Laboratory of Inflammatory Skin Diseases at Mount Sinai, told Healio. “The results are quite promising, not only in terms of efficacy in 16 weeks, but in that this treatment might be related to disease modification.”
The study found KHK4083’s efficacy to continue after the 16-week treatment period, suggesting long-term therapeutic effect, according to the release.
Full study results are expected to be presented through future conferences and publications.