Keymed Biosciences Inc., presented at the European Academy of Allergy and Clinical Immunology Congress 2024 with data from a Phase III clinical trial of stapokibart injection for moderate-to-severe atopic dermatitis (AD). The trial demonstrated sustained efficacy and safety of long-term stapokibart treatment in adult patients with moderate-to-severe AD, with no new safety concerns.

This Phase III trial was multicenter, randomized, double-blind, and placebo-controlled, aiming to assess stapokibart's efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with moderate-to-severe AD. A total of 476 patients entered the maintenance treatment phase, equally distributed between groups. By week 52, 92.5% of patients on stapokibart and 88.7% of those switching from placebo achieved Eczema Area and Severity Index (EASI-75) improvement, while 67.3% and 64.2%, respectively, reached an Investigator's Global Assessment (IGA) score of 0/1 with a ≥2-point reduction. Additionally, 67.3% and 60.5% of patients, respectively, achieved a ≥4-point reduction in the weekly average of the Peak Pruritus Numerical Rating Scale (PP-NRS). Long-term stapokibart treatment consistently improved AD symptoms and quality of life, with only 0.9% experiencing relapse during the maintenance period. Stapokibart was well-tolerated, with its safety profile remaining consistent over 52 weeks.

The trial randomized 500 adult patients 1:1 to receive stapokibart or placebo every two weeks for 16 weeks, followed by a 36-week maintenance phase. Stapokibart is a humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), blocking both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, key cytokines in type 2 inflammation. It has shown promise in previous clinical trials and has been accepted for new drug application for moderate-to-severe atopic dermatitis in adults by the NMPA, with priority review granted on December 7, 2023.

Source: prnewswire.com