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Gilead to begin human trials for the inhaled version of coronavirus drug remdesivir

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A lab technician visually inspects a filled vial of investigational coronavirus disease (COVID-19) treatment drug remdesivir at a Gilead Sciences facility in La Verne, California, March 11, 2020.

Gilead Sciences | via REUTERS

Gilead Sciences will begin human trials for an inhaled version of its antiviral drug remdesivir in August, the biotech company said Monday.

Remdesivir, which was granted an emergency use authorization (EUA) from the Food and Drug Administration to treat patients hospitalized with Covid-19, is administered intravenously. The company told investors in April that it was looking to develop easier-to-administer versions of the drug, including an inhaled version. The drug can’t be administered in pill form because its chemical makeup would impact the liver, the company noted.

Gilead said it will administer the drug through a nebulizer, a delivery device that can turn liquid medicines into mist.

An inhaled version “could potentially allow for easier administration outside the hospital, at earlier stages of disease,” Gilead Chairman and CEO Daniel O’Day said in an open letter Monday. “That could have significant implications in helping to stem the tide of the pandemic.”

Gilead will screen healthy volunteers for the early-stage trial and hope to begin studies in patients with Covid-19 in August.

The company said it will also conduct trials using intravenous infusions in outpatient settings such as infusion centers and nursing homes. It is also exploring whether it can improve patient outcomes by combining remdesivir with other therapies.

“Our best hope of beating Covid-19 is with a set of tools at our disposal: complementary therapeutics, effective vaccines and widespread testing,” O’Day said. “Having already seen that science can deliver answers, we can be hopeful of continued progress. Gilead will do all it can to help drive that progress by exploring the full potential of remdesivir.”

There are no FDA-approved drugs to treat Covid-19, which has infected nearly 9 million people worldwide and killed at least 468,589, according to data compiled by Johns Hopkins University. 

Remdesivir was granted a EUA by the FDA in May. Hydroxychloroquine, a malaria drug touted by President Donald Trump, had also been granted a EUA for the coronavirus, but the designation was revoked after the FDA found it was unlikely to be effective.

In April, the National Institute of Allergy and Infectious Diseases released results from its study showing a modest benefit for patients who took remdesivir. It showed Covid-19 patients who took the drug usually recovered after 11 days, four days faster than those who didn’t take the drug.

The company has said it can produce “several million” rounds of its antiviral drug next year to help patients fight the coronavirus.

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