Gilead Sciences, Inc. GILD announced that it has initiated an early-stage study to evaluate its experimental coronavirus treatment, remdesivir, for use in inhaled formulation outside of hospitals
The drug is currently administered to hospitalized patients intravenously.
A phase I study has been initiated to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. This randomized, placebo-controlled study will enroll approximately 60 healthy individuals aged 18-45 years in the United States to form the basis for further clinical study of the inhaled drug, particularly in patients whose disease has not progressed to require hospitalization.
Gilead believes that 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, as the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in the disease.
Moreover, additional clinical studies evaluating remdesivir in combination with anti-inflammatory medicines in vulnerable patient populations and outpatient settings are ongoing or planned to be initiated shortly.
Gilead’s shares have rallied 18.6% in the year so far compared with the industry’s growth of 12.9%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
The FDA also granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic. It was granted regulatory approval in Japan under an exceptional approval pathway. The European Commission has granted conditional marketing authorization to remdesivir as a treatment for SARS-CoV-2 infection, under the brand name Veklury.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion.
Roche RHHBY initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia. Alexion ALXN is also evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
Regeneron REGN has also initiated late-stage studies on its investigational double-antibody cocktail, REGN-COV2, for the treatment of COVID-19. The candidate is being evaluated both for the treatment and prevention of the disease.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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