tetano
Editor, Senior Moderator
J Infect
. 2025 Mar 13:106472.
doi: 10.1016/j.jinf.2025.106472. Online ahead of print. Oral ADC189 for Adults and Adolescents with Uncomplicated Influenza
Jingya Zhao[SUP] 1 [/SUP], Guoping Sheng[SUP] 2 [/SUP], Yingqi Lyu[SUP] 1 [/SUP], Yilan Sun[SUP] 3 [/SUP], Sikui Wang[SUP] 4 [/SUP], Xiaolin Chen[SUP] 5 [/SUP], Feng Ye[SUP] 6 [/SUP], Lin Chen[SUP] 7 [/SUP], Xiaowei Xu[SUP] 8 [/SUP], Hong Wang[SUP] 9 [/SUP], Bin Wu[SUP] 10 [/SUP], Chunxian Peng[SUP] 11 [/SUP], Min Deng[SUP] 12 [/SUP], Lihong Qu[SUP] 13 [/SUP], Xuehong Jiang[SUP] 14 [/SUP], Junyan Hu[SUP] 15 [/SUP], Yan Feng[SUP] 16 [/SUP], Yongzhong Li[SUP] 17 [/SUP], Jie Peng[SUP] 18 [/SUP], Weiyang Li[SUP] 19 [/SUP], Lei Shao[SUP] 20 [/SUP], Feng Gao[SUP] 21 [/SUP], Dongbo Tian[SUP] 22 [/SUP], Jie Tan[SUP] 23 [/SUP], Huanwei Zheng[SUP] 23 [/SUP], Meifang Chen[SUP] 24 [/SUP], Hong Wu[SUP] 25 [/SUP], Xiaoyun Zhu[SUP] 26 [/SUP], Min Zhou[SUP] 27 [/SUP], Jieming Qu[SUP] 28 [/SUP]
Affiliations
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[SUB]10[/SUB] 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.).
Keywords: ADC189; Efficacy; Influenza; Safety.
. 2025 Mar 13:106472.
doi: 10.1016/j.jinf.2025.106472. Online ahead of print. Oral ADC189 for Adults and Adolescents with Uncomplicated Influenza
Jingya Zhao[SUP] 1 [/SUP], Guoping Sheng[SUP] 2 [/SUP], Yingqi Lyu[SUP] 1 [/SUP], Yilan Sun[SUP] 3 [/SUP], Sikui Wang[SUP] 4 [/SUP], Xiaolin Chen[SUP] 5 [/SUP], Feng Ye[SUP] 6 [/SUP], Lin Chen[SUP] 7 [/SUP], Xiaowei Xu[SUP] 8 [/SUP], Hong Wang[SUP] 9 [/SUP], Bin Wu[SUP] 10 [/SUP], Chunxian Peng[SUP] 11 [/SUP], Min Deng[SUP] 12 [/SUP], Lihong Qu[SUP] 13 [/SUP], Xuehong Jiang[SUP] 14 [/SUP], Junyan Hu[SUP] 15 [/SUP], Yan Feng[SUP] 16 [/SUP], Yongzhong Li[SUP] 17 [/SUP], Jie Peng[SUP] 18 [/SUP], Weiyang Li[SUP] 19 [/SUP], Lei Shao[SUP] 20 [/SUP], Feng Gao[SUP] 21 [/SUP], Dongbo Tian[SUP] 22 [/SUP], Jie Tan[SUP] 23 [/SUP], Huanwei Zheng[SUP] 23 [/SUP], Meifang Chen[SUP] 24 [/SUP], Hong Wu[SUP] 25 [/SUP], Xiaoyun Zhu[SUP] 26 [/SUP], Min Zhou[SUP] 27 [/SUP], Jieming Qu[SUP] 28 [/SUP]
Affiliations
- PMID: 40089214
- DOI: 10.1016/j.jinf.2025.106472
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[SUB]10[/SUB] 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.).
Keywords: ADC189; Efficacy; Influenza; Safety.