Gilead Sciences has initiated a phase Ia clinical trial of an inhaled nebulised version of the remdesivir to treat COVID-19 patients whose infection has not progressed to hospitalisation.
Based on recent research, it is understood that the SARS-CoV-2 virus infects the upper respiratory tract during the early stages of the disease. The company expects that direct delivery of its drug to the primary site of infection with a nebulised, inhaled solution could allow targeted and accessible administration in non-hospitalised patients. The approach may also help lower the systemic exposure to the drug avoiding any adverse effect.
Currently, the randomised, placebo-controlled study is set to launch in the US to evaluate the safety, tolerability and pharmacokinetics of the new formulation in 60 healthy participants aged 18-45.
Data from this phase Ia trial will aid the company to plan a further clinical study of the inhaled formulation, primarily in patients whose infection has not progressed to hospitalisation.
The company received approval from the US Food and Drug Administration (FDA) in June to investigate an inhaled version of remdesivir in human clinical trials as a potential treatment for COVID-19 patients.