Dr. Anthony Fauci, the top infectious diseases expert in the United States, has said he expects the Food and Drug Administration to fast-track approval of the drug, which was shown in a study to shorten recovery time of hospitalized patients.
Global News spoke with two Canadian scientists about their thoughts on the early findings on remdesivir, how the drug works and what the next steps are.
Caution on findings
Dr. Rob Fowler from Toronto’s Sunnybrook Hospital said it’s too early to read into the results of the preliminary data out of the U.S. so far. The data needs to be peer reviewed, he said.
“I think that if we get a bit of a teaser from from Dr. Fauci, that’s terrific,” he said on Thursday night. “But we really need to be able to have a look at the the full data and hopefully that will come soon.”
Another study on remdesivir, out of China and based on a smaller number of patients, showed the drug does not speed up recovery in critically ill patients. The authors of that study did warn that their findings were limited because the trial ended early — there weren’t enough patients once cases in China took a nosedive. The conclusion was that more evidence from clinical trials is necessary.
Dr. Matthias Gotte from the University of Alberta says he wouldn’t call this week’s early findings about remdesivir a game-changer, but they’re “certainly an important milestone.”
The speed at which data around COVID-19 has emerged amazes him, he said.
“Within four months from the discovery of the disease to now to data, completion of a randomized clinical trial with positive data, in four months,” Gotte said. “It’s just amazing. So that is the good news.”
Researchers can now “build up” on this momentum,” he said.
How it works
Even before the novel coronavirus that caused a global pandemic appeared on the scene, remdesivir was being examined for its antiviral activity against other coronaviruses that cause illnesses such as SARS and MERS.
Gotte from the University of Alberta and his fellow researchers from the biochemistry lab are interested in how exactly that antiviral action works.
“Others had shown before that there is an antiviral effect in cell culture and animal experiments, but it was not quite clear how it actually works,” he said.
While their work complements the clinical trials, they are not actively involved in them, he explained.
Their research shows that remdesivir basically targets an important enzyme in coronaviruses that allows it to spread. Gotte calls this enzyme — the polymerase — the “engine” of the virus, which allows it to replicate and spread.
“We have shown that remdesivir inhibits this engine of the virus,” Gotte said.
The way it works is that the engine of the virus needs gas, but remdesivir delivers diesel, he explained.
“So at a certain point, it just stops to work and then the virus cannot replicate or spread anymore,” he said.
As Reuters reported, preliminary results from a 1,063-patient U.S. trial showed that patients who were given the drug recovered faster than those on a placebo — 31 per cent faster, to be specific. Their recovery time was 11 days as opposed to 15 days.
One clinical trial participant, 29-year-old Drew McDonald, told CBS News that he was seriously ill when he received the drug.
“By the time I left the hospital, I was already improving drastically,” he said.
At present, COVID-19 is a disease with no approved treatments or vaccines. More than 3.2 million cases around the world were reported as of Thursday, according to data tracked by Johns Hopkins University. More than 233,000 worldwide have died from COVID-19 so far, with 3,184 of those deaths in Canada.
Fowler and Gotte both say they and others in the research community are awaiting the full data.
Gotte said the most important questions to ask then will be who will benefit from remdesivir — people with mild symptoms or severe ones?
“Can we still help patients if the disease is already in an advanced state, or can we only help patients if we treat very early after they get infected?” he said.
Fowler said he’s “forever hopeful.”
“But I think until we’re able to see the full results, the full range of benefits, the potential full range of side effects, then I think it’s just premature,” he said.
According to Reuters, Gilead said on Thursday that it will work with global partners to ramp up production of the potential treatment, which is given to hospitalized patients by intravenous infusion.
The company also said it has been in constant talks with the FDA about making remdesivir available to patients as quickly as possible, and that the FDA could issue an emergency use authorization.
Detailed results from the U.S. study are expected in May, and numerous other studies are also examining the drug.
For instance, The European Medicines Agency has said it is conducting a ‘rolling review’ of data on remdesivir. A rolling review essentially allows the agency to speed up assessments of promising new drugs during a public health emergency.
— With files by Global News Jackson Proskow, The Associated Press, ReutersView link »