Inhaled Phosphatidylinositol 4-Kinase Beta (PI4KB) Inhibitor for the Treatment of Experimental Rhinovirus Infection in Patients with Asthma: A Phase 1b Randomized Controlled Study of GSK3923868

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2026
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Abstract
BACKGROUND: Rhinovirus (RV) replication requires the host enzyme, phosphatidylinositol 4-kinase beta (PI4KB). GSK3923868 is an inhibitor of PI4KB being developed to treat RV-associated exacerbations of respiratory disease. The primary objective of this phase 1b study (NCT05398198) was to evaluate the impact of once daily administration of inhaled GSK3923868 on lower respiratory tract symptoms (LRTS) in patients with asthma following experimental RV-16 infection. METHODS: Adults with mild-to-moderate asthma, with reactive airways and positive skin prick test, were inoculated with RV-16. Two days afterwards, successfully infected participants (with cold-like symptoms) were randomized to receive GSK3923868 3000 µg or placebo once daily for 10 days. A second cohort received GSK3923868 1500 µg or placebo once daily for 10 days. Symptoms were recorded 3 times daily by participants and lung function (forced expiratory volume in 1 second [FEV1], peak expiratory flow [PEF]) was tested. Safety was also assessed. RESULTS: LRTS (area under the curve in change from baseline) decreased by 47% and 51% with the 3000 µg dose and 1500 µg dose, respectively, from viral inoculation to discharge, and by 70% and 62%, respectively, from first dose to discharge, versus placebo. Maximal LRTS scores were reduced numerically with GSK3923868 treatment versus placebo and symptoms following infection occurred later on placebo. GSK3923868 was well tolerated, with no safety concerns and no significant differences in FEV1 or PEF between groups. CONCLUSIONS: Inhaled treatment with PI4KB inhibitor GSK3923868 demonstrated LRTS reduction in an experimental model of RV infection, with a good safety profile in participants with asthma.
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Authors Yau Lun Man, Melissa Bevan, Preet D’Abreo, Alex J Mann, Tal Otiker, Disala Fernando, Anthony P. Cahn
Journal The Journal of infectious diseases
Year 2026
DOI
10.1093/infdis/jiag514
URL
https://doi.org/10.1093/infdis/jiag514
Keywords Keywords not found

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