Amgen and Kyowa Kirin announce positive study data from their phase 2 trial of AMG 451/KHK4083.
Amgen and Kyowa Kirin Co., Ltd announced positive data from a phase 2 study (NCT03703102) of AMG 451/KHK4083 (Amgen and Kyowa Kirin Co), a potential first-in-class anti-OX40 fully human monoclonal antibody, was presented at the European Academy of Dermatology and Venereology (EADV) 30th annual virtual congress. AMG 451/KHK4083 is in development for the treatment of moderate to severe atopic dermatitis (AD).1
Emma Guttman-Yassky, MD, PhD, was the lead investigator of the study. She is the 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, New York, New York.
“The phase 2 results are both positive and exciting,” said Guttman-Yassky. “They show improvement across all 4 dose groups compared to placebo and highlight the potential of OX40 antagonism to help patients. 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.”
The multicenter, randomized, double-blind, placebo-controlled trial investigated both the safety and efficacy of AMG 451/KHK4083 in adult patients with moderate to severe AD that was not controlled with topical treatments.
The study met the primary objective, according to the press release, showing statistically greater improvements from baseline in Eczema Area and Severity Index (EASI) score at 16 weeks with all 4 subcutaneous doses of AMG 451/KHK4083 compared to placebo (600-mg every 2 weeks [Q2W] = -57.4%; 600-mg Q4W = -49.7%; 300-mg Q2W = -61.1%; 150 mg Q4W = -48.3% vs placebo = -15%; P < .001).1
All patients in the treatment arms of AMG 451/KHK4083 achieved improvements compared to placebo at week 16, and continued to improve afterwards for key secondary endpoints. This included 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).1
Common adverse events (AEs) reported in at least 5% of patients were pyrexia (mild to moderate), nasopharyngitis, worsening of atopic dermatitis, and chills. The events of pyrexia did not lead to treatment discontinuation.
"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, PhD, executive officer, vice president, head of R&D division of Kyowa Kirin, Japan. "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, MD, executive vice president of research and development at Amgen, Thousand Oaks, California. "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."
1. 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. Cision PR Newswire. Press Release. Published October 2, 2021. Accessed October 8, 2021. https://www.prnewswire.com/news-releases/amgen-and-kyowa-kirin-present-positive-late-breaking-data-from-phase-2-study-of-amg-451khk4083-in-adult-patients-with-moderate-to-severe-atopic-dermatitis-at-eadv-congress-301391185.html