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Amgen And Kyowa Kirin Present Positive Late-Breaking Data From Phase 2 Study Of AMG 451/KHK4083 In Adult Patients With Moderate-to-Severe Atopic Dermatitis At EADV Congress

Published: 2021-10-02 10:00:00 ET

The Study Met its Primary Objective of Demonstrating a Statistically Greater Improvement From Baseline in Eczema Area and Severity Index Score at 16 Weeks Versus Placebo

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

THOUSAND OAKS, Calif. and TOKYO, Oct. 2, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE:4151) today announced that positive data from a Phase 2 study of AMG 451/KHK4083 were presented at the European Academy of Dermatology and Venereology 30th Virtual Congress on Oct. 2, 2021. AMG 451/KHK4083 is a potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of moderate-to-severe atopic dermatitis.

The Phase 2, 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 (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

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