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AMGEN® 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 October 2 , 2021 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 < 0.001 ) . 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 . " The Phase 2 results are both positive and exciting . They show improvement across all 4 dose groups compared to placebo , and highlight the potential of OX40 antagonism to help patients , " said the lead investigator of this study , Dr. Emma Guttman - Yassky , MD./PhD . , system chair for the Department of Dermatology and Waldman Professor of Dermatology and Immunology , 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 . " I hope that future clinical development data will further elucidate the significance and potential of AMG 451 / KHK4083 in the treatment of moderate - to - severe atopic dermatitis . " " We are very pleased to present data from our Phase 2 study assessing the efficacy and safety of AMG 451 / KHK4083 in chronic , recurrent , moderate- to - severe atopic dermatitis at the EADV congress , " said Yoshifumi Torii , Ph.D. , executive officer , vice president , head of R & D Division of Kyowa Kirin . " The results show inhibition and deletion of the OX40 - expressing cells may provide an important new approach to treating moderate - to - severe atopic dermatitis , with the potential to help patients maintain responses . " " Atopic dermatitis affects nearly 30 million people a year and is known to have an extremely negative impact on patients ' lives , " said David M. Reese , M.D. , executive vice president of Research and Development at Amgen . " These data provide strong evidence of the potential of AMG 451 / KHK4083 for patients , and we look forward to studying this treatment further in Phase 3 clinical trials , which we expect to begin in the first half of 2022. " About the AMG 451 / KHK4083 Phase 2 Study The Phase 2 , multicenter , randomized , double - blind , placebo - controlled trial ( NCT03703102 ) 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 randomized 274 patients in the U.S. , Japan , Canada and Germany across four dose - ranging active treatment groups , which received subcutaneous AMG 451 / KHK4083 ( 600mg Q2W , 600mg Q4W , 300mg Q2W , 150mg Q4W ) , and a comparator placebo arm . The primary endpoint was percentage change from baseline in EASI score at week 16. Additional endpoints include achievement of ≥75 % reduction ( improvement ) from baseline in EASI score , IGA score of 0 ( clear ) or 1 ( almost clear ) with ≥ 2 points reduction from baseline , and ≥ 4 points reduction from baseline in the pruritus numeric rating scale ( NRS ) score . Patients in the study were followed up to week 56 . The presentation slides are available on the EADV website : https://www.eadvcongress2021.org/ . Dr. Emma Guttman - Yassky is the lead investigator of the study and a paid consultant for the AMG 451 / KHK4083 development by Kyowa Kirin . About Atopic Dermatitis Atopic dermatitis is a chronic inflammatory disease that causes excessively dry , itchy skin that can be painful . Repeated scratching can cause the skin to thicken , harden or become vulnerable to infection . Atopic dermatitis is the most common form of eczema – affecting 1-3 % of adults worldwide - and the prevalence is increasing . The disease typically manifests in childhood followed by other allergy symptoms . About AMG 451 / KHK4083 AMG 451 / KHK4083 is an anti - OX40 fully human monoclonal antibody engineered with Kyowa Kirin's patented POTELLIGENTⓇ defucosylation technology to enhance its antibody - dependent cellular cytotoxicity ( ADCC ) activity . The initial AMG 451 / KHK4083 antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology . AMG 451 / KHK4083 targets and inhibits the activity of the OX40 receptor expressed on the surface of activated effector T - cells , and has been shown to