Gilead said "positive data emerging from the National Institute of Allergy and Infectious Diseases'" study of remdesivir indicates the treatment has "met its primary endpoint" and that more details will be made available an at upcoming briefing, which could be held later today at the White House.
In a separate statement, Gilead said its own study showed that nearly two thirds of the nearly 400 severe-stage coronavirus patients using remdisivir were discharged from hospital after using the treatment early, a better rate than those given the drug at a later stage.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said chief medical officer Merdad Parsey. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir."
"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. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
Gilead shares were marked 4% higher in early trading at $81.77 each Wednesday after they resumed trading following news of the NIAID trial, while the Dow Jones Industrial Average surged 500 points shortly after the opening bell.
Last week, reports leaked on the World Health Organization website suggested remdesivir had little success in a China-based study that was halted after authorities said there weren't enough patients enrolled.
"We regret that the WHO prematurely posted information regarding the study, which has since been removed," Gilead said in a statement. "The investigators in this study did not provide permission for publication of results."
"Furthermore, we believe the post included inappropriate characterizations of the study,' Gilead said at the time. "Importantly, because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions."