Huang, Li-Min and Schibler, Andreas and Huang, Yi-Chuan and Tai, Andrew and Chi, Hsin and Chieng, Chae-Hee and Wang, Jinn-Li and Goldbart, Aviv and Tang, Swee-Ping and Huang, Yhu-Chering and George, Shane and Alabaz, Derya and Bentur, Lea and Su, Siew-Choo and de Bruyne, Jessie and Karadag, Bulent and Gu, Feng and Zou, Gang and Toovey, Stephen and DeVincenzo, John P. and Wu, Jim Z. (2023) Safety and efficacy of AK0529 in respiratory syncytial virus-infected infant patients: A phase 2 proof-of-concept trial. Influenza and Other Respiratory Viruses, 17 (7). ISSN 1750-2640, DOI https://doi.org/10.1111/irv.13176.
Full text not available from this repository.Abstract
BackgroundRespiratory syncytial virus (RSV) infection is a cause of substantial morbidity and mortality in young children. There is currently no effective therapy available. MethodsThis was a Phase 2 study of the oral RSV fusion protein inhibitor AK0529 in infants aged 1-24 months, hospitalized with RSV infection. In Part 1, patients (n = 24) were randomized 2:1 to receive a single dose of AK0529 up to 4 mg/kg or placebo. In Part 2, patients (n = 48) were randomized 2:1 to receive AK0529 at 0.5, 1, or 2 mg/kg bid or placebo for 5 days. Sparse pharmacokinetic samples were assessed using population pharmacokinetics modelling. Safety, tolerability, viral load, and respiratory signs and symptoms were assessed daily during treatment. ResultsNo safety or tolerability signals were detected for AK0529: grade & GE;3 treatment-emergent adverse events occurring in 4.1% of patients in AK0529 and 4.2% in placebo groups, respectively, and none led to death or withdrawal from the study. In Part 2, targeted drug exposure was reached with 2 mg/kg bid. A numerically greater reduction in median viral load with 2 mg/kg bid AK0529 than with placebo at 96 h was observed. A -4.0 (95% CI: -4.51, -2.03) median reduction in Wang Respiratory Score from baseline to 96 h was observed in the 2 mg/kg group compared with -2.0 (95% CI: -3.42, -1.82) in the placebo group. ConclusionsAK0529 was well tolerated in hospitalized RSV-infected infant patients. Treatment with AK0529 2 mg/kg bid was observed to reduce viral load and Wang Respiratory Score. Clinical Trials RegistrationNCT02654171.
| Item Type: | Article |
|---|---|
| Funders: | Ark Biosciences Pty Ltd, Ministry of Health and Welfare, Taiwan (MOHW110-TDU-B-211-124002) |
| Uncontrolled Keywords: | AK0529; fusion inhibitor; infants; respiratory syncytial virus (RSV); ziresovir |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Universiti Malaya Medical Centre (UMMC) |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 06 Oct 2025 02:42 |
| Last Modified: | 06 Oct 2025 02:42 |
| URI: | http://eprints.um.edu.my/id/eprint/50243 |
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