Oral ADC189 for Adults and Adolescents with Uncomplicated Influenza.

• Tác giả: Lin Chen, Meifang Chen, Xiaolin Chen, Min Deng, Yan Feng, Feng Gao, Junyan Hu, Xuehong Jiang, Weiyang Li, Yongzhong Li, Yingqi Lyu, Chunxian Peng, Jie Peng, Jieming Qu, Lihong Qu, Lei Shao, Guoping Sheng, Yilan Sun, Jie Tan, Dongbo Tian, Hong Wang, Sikui Wang, Bin Wu, Hong Wu, Xiaowei Xu, Feng Ye, Jingya Zhao, Huanwei Zheng, Min Zhou, Xiaoyun Zhu
• Ngôn ngữ: eng
• Thông tin xuất bản: England : The Journal of infection , 2025
• Bộ sưu tập: NCBI
• ID: 713907

Tóm tắt

 OBJECTIVES: ADC189 is a novel anti-influenza virus inhibitor. In this study, we aimed to evaluated the safety and efficacy of ADC189 in outpatients with uncomplicated influenza infection. METHODS: In the phase 2 trial, we assigned patients in a 2:2:1 ratio to receive either single dose 15-mg or 45-mg of ADC189 or placebo. In the phase 3 part, participants were randomized in a 2:1 ratio to receive 45-mg of ADC189 or placebo. The primary end point was the time to alleviation of influenza symptoms in the intention-to-treat infected population. RESULTS: In the phase 2 trial that had 150 participants, the median time for virus RNA clearance was shorter in both ADC189 groups (15-mg group, 50·7hours
  45 mg-group, 45·8hours) compared to the placebo group (73·4hours
  p=0·69 and 0·016, respectively). 617 participants were enrolled in the phase 3 trial. The median time to symptom alleviation was 50·0hours (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1hours (95% CI, 62·8 to 84·4) with placebo (p<
 0·0001). By 1 day after initiation, the decrease in viral load from baseline was greater in the ADC189 group than in the placebo group (2·316 and 1·049 log CONCLUSIONS: A single-dose ADC189 shorten the time to the resolution of symptoms among adults and adolescents with uncomplicated influenza, without evident safety concerns. (Funded by Jiaxing AnDiCon Biotech Co., Ltd, Zhejiang, China
  ChiCTR number, 20230137, and ClinicalTrials. gov number, NCT06342921.).