The study enrolled 274 patients with moderate to severe atopic dermatitis. Credit: James Heilman, MD via Wikipedia.

Speciality pharmaceutical company Kyowa Kirin has reported that the Phase II study of an investigational agent, KHK4083, in patients with atopic dermatitis, met the primary endpoint.

Discovered by Kyowa Kirin, KHK4083 is a potential first-in-class, anti-OX40 fully human monoclonal antibody for treating autoimmune diseases.

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Atopic dermatitis is a chronic, pruritic, inflammatory dermatosis in which the main lesion is itchy eczema that flares up recurrently.

The multicentre, randomised, double-blind and placebo-controlled clinical study was carried out in Japan, the US, Canada and Germany to assess the efficacy and safety of KHK4083.

The study enrolled 274 patients with moderate to severe atopic dermatitis, not adequately controlled with topical agents.

Results showed that all KHK4083 cohorts achieved statistically significant superiority over the placebo cohort, thereby meeting the primary endpoint of percentage change from the baseline in the Eczema Area and Severity Index (EASI) at 16 weeks.

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Furthermore, all KHK4083 cohorts showed significant difference over the placebo group in the percentage of patients achieving an EASI-75 at 16 weeks and the percentage of patients achieving the Investigator’s Global Assessment (IGA) of 0 or one with an improvement of two points or more at 16 weeks.

Efficacy improvement of the antibody was observed after 16 weeks with no events of severe hypersensitivity reactions and death noted in the study.

Kyowa Kirin Global R&D Division head, executive officer, vice-president Yoshifumi Torii said: “We are very pleased with the results of this study assessing efficacy and safety of KHK4083 in chronic, recurrent, moderate to severe atopic dermatitis.

“We look forward to sharing the results of the full analysis in the near future. We will continue KHK4083 development with the hope it can help patients in need.”

Last October, Kyowa Kirin reported that the MAVORIC trial of Poteligeo (mogamulizumab) in patients with mycosis fungoides (MF) and Sézary syndrome (SS) achieved overall investigator-assessed progression-free survival (PFS).