Gilead Sciences on Wednesday stated that it has initiated a Phase Ia study testing an inhaled formulation of its COVID-19 treatment remdesivir for use in the outpatient setting. "Based on current scientific understanding, the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in disease," chief medical officer Merdad Parsey said, adding that "delivering remdesivir directly to the primary site of infection with a nebulised, inhaled solution may enable more targeted and accessible administration in non-hospitalised patients and potentially lower systemic exposure to the drug."
The randomised, placebo-controlled trial will enroll roughly 60 healthy volunteers aged 18 to 45 in the US to form the basis for further clinical testing of the inhaled drug, particularly in patients whose disease has not progressed to the point of requiring hospitalisation. Gilead first announced plans for the study last month.
Remdesivir, currently administered intravenously through daily infusions, was authorised by the FDA for emergency use in early May to treat adult and paediatric patients who are in hospital with severe COVID-19 disease. The decision followed the release of preliminary results from the Phase III ACTT trial showing that it cut recovery times by an average of four days, compared to placebo. The antiviral was also granted conditional approval last week in Europe under the name Veklury for use in certain patients 12 years and older with pneumonia requiring supplemental oxygen.
Parsey suggested that from the beginning, it has been clear that Gilead would have to develop a coronavirus treatment solution for outpatient uses, noting that "significant research efforts" led to the inhaled version of remdesivir. "Research on this inhaled solution…represents an important pillar of our ongoing work that aims to potentially enhance patient outcomes with remdesivir and enable more patients to access this treatment," he added.
Meanwhile, Gilead said additional clinical trials evaluating remdesivir in combination with anti-inflammatory medicines, in vulnerable patient populations and in outpatient settings are ongoing or planned to initiate in the near future. The company recently disclosed that remdesivir would be priced at $390 per vial in the US and other developed countries, with a five-day treatment course of six vials costing $2340 per patient.
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