Gilead Sciences Chairman and CEO Daniel O’Day has announced that the company has received FDA approval for a Phase 1 trial of inhaled remdesivir and will initiate the study within a week. Trials of the inhaled antiviral formulation in COVID-19 patients are expected to begin in August 2020.
O’Day said, “Remdesivir, our investigational antiviral medicine, is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease. That could have significant implications in helping to stem the tide of the pandemic.”
The drive to develop a formulation useful earlier in the disease is based on the results of a study showing that treatment with remdesivir for COVID-19 was most effective prior to a need for mechanical ventilation, O’Day said, adding “The totality of these data shows that remdesivir has the potential to be of meaningful benefit to patients with COVID-19 and offers important hope. In our ongoing studies, we will work to deliver on that hope and potentially benefit more patients.”
Read Gilead’s open letter from Daniel O’Day.