Amgen (NASDAQ:AMGN) and Kyowa Kirin (OTCPK:KYKOF)announce that positive data from a Phase 2 study of AMG 451/KHK4083 were presented at the 30th EADV Congress on Oct. 2, 2021.
The Phase 2 trial investigated the efficacy and safety of AMG 451/KHK4083 in adults with moderate-to-severe atopic dermatitis (AD) 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 (600 mg every two weeks (Q2W) = -57.4%; 600 mg Q4W = -49.7%; 300 mg Q2W = -61.1%; 150 mg Q4W = -48.3% vs. placebo = -15%; P<0.001).
Also, patients receiving AMG 451/KHK4083 showed statistically greater improvements in additional secondary efficacy endpoints versus placebo.
AMG 451/KHK4083 also showed progressive improvement in efficacy beyond 16 weeks.
The company looks forward to study this treatment further in Phase 3 trials, which are expected to begin in H1 2022.