Positive data from a Phase 2 study of AMG 451/KHK4083, presented at the European Academy of Dermatology and Venereology 30th Virtual Congress, show that the potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of moderate-to-severe atopic dermatitis offers efficacy for the inflammatory disease.

The multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of AMG 451/KHK4083 in adults with moderate-to-severe atopic dermatitis who were not adequately controlled with topical agents. The study met the primary objective, showing statistically greater improvements from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks with all four subcutaneous doses of AMG 451/KHK4083 compared with placebo. The studied doses were 600mg every two weeks, 600mg every four weeks; 300mg every two weeks, and 150mg every four weeks.

AMG 451/KHK4083 is in development by Amgen and Kyowa Kirin Co., Ltd., who reported the presentation.

All treatment groups of patients receiving AMG 451/KHK4083 generally achieved improvements compared to placebo at week 16 for key secondary endpoints, such as achieving at least a 75% reduction from baseline in EASI score (EASI-75), an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least 2-point reduction from baseline (IGA 0/1) and at least a 4-point reduction from baseline in pruritus Numerical Rating Scale (NRS) score (PNRS-4). Efficacy measures continued to improve after week 16 for all AMG 451/KHK4083 doses.

The most commonly reported adverse events that occurred in at least 5% of patients were pyrexia, nasopharyngitis, worsening of atopic dermatitis and chills. The events of pyrexia and chills were mild to moderate in intensity and did not lead to treatment discontinuations.