The much-awaited results of U.S. trial of Gilead Sciences, Inc.'s GILD investigational antiviral therapy remdesivir in treating coronavirus infection arrived Wednesday.
The Forest City, California-based company said it is "aware" that the National Institute of Allergy and Infectious Diseases study has met the primary endpoint, and added that the NIAID will provide detailed information at an upcoming briefing.
Separately, Gilead announced top-line results from the Phase 3 study dubbed SIMPLE that evaluated five-day and 10-day dosing durations of remdesivir in hospitalized patients with severe manifestations of COVID-19 disease, showing similar improvement in clinical status for both dosing regimens.
No new safety signals emerged from the two treatment groups, according to Gilead.
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"The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir," Merdad Parsey, chief medical officer at Gilead, said in a statement.
The time to clinical improvement for 50% of the patients was 10 days in the five-day treatment group compared to 11 days for the 10-day treatment group. More than half of patients in both treatment groups were discharged from hospital by day 14, the company said.
In premarket trading Wednesday, Gilead shares were surging higher by 8.2% to $85.12.
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