Coronavirus drug raises hopes

‘Enough data’ to show benefit of remdesivir

Gilead Sciences Inc. on Wednesday said its experimental antiviral drug remdesivir helped improve outcomes for patients with COVID-19 in a clinical trial, and provided data suggesting it worked better when given earlier in the course of illness.

The drug has been watched closely in the past few weeks following the release of several studies that painted a mixed picture of its effectiveness.

“There’s now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line,” former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter, referring to the National Institute of Allergy and Infectious Diseases.

Gilead provided information on two clinical trials. The study being conducted by the NIAID met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus, Gilead said.

Results from that trial have been highly anticipated because it compares how patients who received remdesivir fared versus those given a placebo, meaning it should definitively demonstrate whether the drug provides benefit.

Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centres, which does not compare remdesivir to a placebo.

In that trial, Gilead said 62 per cent of patients treated early with remdesivir were discharged from the hospital, compared with 49 per cent of patients who were treated later in the course of the infection.

“This is good news for Gilead and the market,” Jefferies analyst Michael Yee said in a research note.

The 397-patient trial evaluated the safety and efficacy of five-day and 10-day regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19.

“The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated,” said Gilead Chief Medical Officer Merdad Parsey.

Gilead has defended the prospects for remdesivir against signs it may not provide a significant benefit.

Results were also published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition. Gilead said previously that those findings, released inadvertently by the World Health Organization last week, were inconclusive because the study was terminated early.

Dr. Mike Ryan, head of the WHO’s emergencies program, declined to comment Wednesday on reports that Gilead Science’s remdesivir could help treat COVID-19, but said further data was needed.