爱科百发启动RSV预防抗体AK0610的II期临床研究

Core Viewpoint - Shanghai Aikebaifa Biopharmaceutical Technology Co., Ltd. has officially launched the Phase II clinical study of its fully human monoclonal antibody injection AK0610 for the prevention of respiratory syncytial virus (RSV) infection, marking a significant advancement in RSV prevention following its therapeutic drug development [1] Group 1: Clinical Study Details - The Phase II clinical trial is a multi-center, randomized, double-blind, placebo-controlled, dose-escalation study aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of AK0610 in healthy infants in China, led by professors from Capital Medical University and Sichuan University [1] - The study will focus on assessing the safety and pharmacokinetics of AK0610 in healthy infants, providing crucial data for subsequent Phase III clinical trials [3][4] Group 2: RSV Background and Need - RSV is the most significant viral pathogen causing acute lower respiratory tract infections (ALRTI) in children under five globally, with over 80% of children infected by age one and nearly all by age two [2] - High-risk groups, particularly premature infants and young children, often experience severe symptoms requiring hospitalization, highlighting the urgent need for effective preventive measures against RSV [2] Group 3: AK0610 Characteristics - AK0610 is a monoclonal antibody targeting the RSV F protein, exhibiting unique viral binding sites and mechanisms, maintaining high neutralizing activity against variant RSV strains, especially the B type [3] - Preclinical studies have shown that AK0610 has strong and specific RSV neutralizing activity and good safety characteristics, with a long half-life allowing for sustained protection throughout the RSV season [3][4]