Oral ADC189 for Adults and Adolescents with Uncomplicated Influenza.

Abstract

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 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.).