Gilead Sciences revealed more trial data on Friday showing its experimental Covid-19 drug significantly reduced the risk of death, an early sign that the antiviral treatment may go beyond just speeding up recovery.
The California-based biotech group said its remdesivir treatment showed a 62 per cent reduction in the risk of death compared with standard treatment. Gilead shares added more than 2 per cent in early trading, and the lacklustre S&P 500 equities index rose on the hopes.
But the study only compared patients with a historical group of patients, rather than the gold standard of a randomised control trial. Gilead said it was an “important finding that requires confirmation in prospective clinical trials”.
Merdad Parsey, chief medical officer, said Gilead was “working to broaden our understanding of the full utility of remdesivir”.
“To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” he said in a press statement.
Remdesivir received emergency use authorisation in the US after a large randomised control trial of more than a thousand patients led by the National Institutes of Health showed that it cut the time to recovery to 11 days, from 15 in the placebo group. In that trial, remdesivir showed an effect on mortality rates but it was not statistically significant.
The drug, developed as a potential medicine for Ebola, has now been given the green light in the EU and the UK. Brussels is in talks with the pharmaceutical group to reserve doses of remdesivir after the US said it had bought up most of the global supply. Gilead also announced last week that it would charge governments in developed countries $2,340 per five-day course per patient.
The SIMPLE trial, a late stage trial by Gilead, included 312 patients, compared with a historical group of more than 800 patients on the “standard of care”, or the usual drugs to help patients on oxygen or ventilator. The majority were based in the US.
Andrew Hill, a senior visiting research fellow at the University of Liverpool’s pharmacology department, said it was “deeply flawed” to compare the trial results with data collected from patients who were not in a randomised trial.
Walid Gellad, associate professor of medicine at the University of Pittsburgh, said it was not the way to determine whether a drug improved mortality. “We need to know what the World Health Organization and the Discovery trial [a large European trial] find for remdesivir,” he said.
The analysis of data from the trial and from “compassionate use” programmes found that all racial and ethnic groups studied experienced similar clinical outcomes on the drug and remdesivir also helped pregnant and post-partum women recover.
Gilead plans to launch a trial to evaluate the safety of remdesivir for children up to the age of 18 and is collaborating on a study for pregnant women. It is also testing an inhaled version of the drug, which it hopes could be used before a patient’s condition is serious enough to be hospitalised.