The first drugmaker to get an authorization from the Food and Drug Administration for an antiviral treatment for Covid-19 has started its first clinical trial of a formulation that may enable its use outside of hospitalized patients.
Foster City, California-based Gilead Sciences said Thursday that it had started a Phase Ia trial of an inhaled version of remdesivir in healthy volunteers in order to test the new formulation’s safety, tolerability and pharmacokinetics. The current version of the drug, under an EUA from the FDA, is delivered intravenously and only for patients who have been hospitalized with severe Covid-19. It is hoped that the inhaled formulation will enable outpatient use of the drug.
“Based on current scientific understanding, the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in disease,” Gilead chief medical officer Merdad Parsey said in a statement. “Delivering remdesivir directly to the primary site of infection with a nebulized, inhaled solution may enable more targeted and accessible administration in non-hospitalized patients and potentially lower systemic exposure to the drug.”
The study does not appear to have been posted yet on ClinicalTrials.gov as of Thursday afternoon, but the company said that it would be randomized and placebo-controlled, enrolling 60 healthy volunteers aged 18 to 45 in the U.S. and would form the basis of further clinical study, especially among patients whose disease has not progressed to the point that they require hospitalization.
The FDA granted the EUA for remdesivir on May 1, based on data from a Phase III study sponsored by the National Institute of Allergy and Infectious Diseases showing that hospitalized patients with Covid-19 who received it were able to be discharged in a median 11 days, compared with 15 days among those who received placebo. However, the drug has not been shown to produce a statistically significant benefit in survival among those patients.
Other antiviral drugs are in development as well, including Regeneron Pharmaceuticals’ REGN-COV2, a two-antibody cocktail in multiple late-stage clinical trials both as a treatment for patients infected with SARS-CoV-2 and as a means to prevent infection among those who have been exposed to the virus.
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