Oral ADC189 for adults and adolescents with uncomplicated influenza.

2025-04
The Journal of infection 90(4)
- Jingya Zhao
- Guoping Sheng
- Yingqi Lyu
- Yilan Sun
- Sikui Wang
- Xiaolin Chen
- Feng Ye
- Lin Chen
- Xiaowei Xu
- Hong Wang
- Bin Wu
- Chunxian Peng
- Min Deng
- Lihong Qu
- Xuehong Jiang
- Junyan Hu
- Yan Feng
- Yongzhong Li
- Jie Peng
- Weiyang Li
- Lei Shao
- Feng Gao
- Dongbo Tian
- Jie Tan
- Huanwei Zheng
- Meifang Chen
- Hong Wu
- Xiaoyun Zhu
- Min Zhou
- Jieming Qu

PubMed: 40089214
DOI: 10.1016/j.jinf.2025.106472

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 617
Population: adults and adolescents with uncomplicated influenza infection
Methods: Two-part trial: phase 2 with 2:2:1 randomization to 15 mg, 45 mg, or placebo; phase 3 with 2:1 randomization to 45 mg or placebo
Funding: Industry-funded

Large Human Trial

Objectives

ADC189 is a novel anti-influenza virus inhibitor. In this study, we aimed to evaluate 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 endpoint 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, 50·7 h; 45 mg-group, 45·8 h) compared to the placebo group (73·4 h; p=0·69 and 0·016, respectively). 617 participants were enrolled in the phase 3 trial. The median time to symptom alleviation was 50·0 h (95% CI, 44·6 to 59·3) with ADC189, as compared with 68·1 h (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 log₁₀ virus copies per milliliter, respectively). Most adverse events were mild or moderate.

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.).