Oral ADC189 for adults and adolescents with uncomplicated influenza

IF 14.3 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2025-03-13 DOI:10.1016/j.jinf.2025.106472

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 , Jieming Qu

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引用次数: 0

Abstract

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, NCT 06342921.)

查看原文本刊更多论文

口服 ADC189 治疗成人和青少年非复杂性流感。

目的：ADC189是一种新型抗流感病毒抑制剂。在本研究中，我们旨在评估ADC189对门诊无并发症流感感染患者的安全性和有效性。方法：在2期试验中，我们以2:2:1的比例分配患者接受单剂量15mg或45mg ADC189或安慰剂。在第三阶段，参与者以2:1的比例随机接受45毫克ADC189或安慰剂。主要终点是意图治疗的感染人群中流感症状缓解的时间。结果：在有150名参与者的2期试验中，两组ADC189清除病毒RNA的中位时间都更短(15 mg组，50.7小时；45毫克组，45.8小时)与安慰剂组(74.3小时；P值分别为0.69和0.016)。617名参与者参加了3期试验。ADC189缓解症状的中位时间为50.0小时（95% CI， 44.6至59.3），而安慰剂组为68.1小时（95% CI， 62.8至88.4）（每毫升分别为p10个病毒拷贝）。大多数不良事件为轻度或中度。结论：单剂量ADC189可缩短成人和青少年无并发症流感患者症状消退的时间，无明显的安全性问题。(浙江省嘉兴市安迪康生物科技有限公司资助；ChiCTR编号20230137，临床试验。网址：NCT06342921)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.