As part of his treatment for the novel coronavirus, U.S. President Donald Trump was given an experimental antibody drug from Regeneron Pharmaceuticals.
The drug, which is currently being studied for use in early infections, apparently made him feel “good immediately.” Trump claimed in a video taken outside the White House that it was “the key” to his improving health.
“I view these — I know they call them therapeutic — but to me, it wasn’t therapeutic, it just made me better,” he said in a Twitter video posted Oct. 7. “I call that a cure.”
Experts are cautioning that it’s far from proven.
Here’s what we know about the drug, its trials and use so far.
What is it?
For starters, it’s not actually a cure, it’s a therapeutic treatment still under analysis.
The antibody cocktail, REGN-COV2, is part of a class of experimental COVID-19 treatments known as monoclonal antibodies — manufactured copies of human antibodies to the virus.
The two antibodies are combined and specifically designed to block the infectivity of COVID-19.
Antibodies are proteins made by the body’s immune system that latch onto and counteract a virus.
In Regeneron’s cocktail, one antibody targets the spike protein the virus uses to drill into healthy cells, and another targets a different part of the coronavirus. Together, the aim is to trap and shut down viral replication.
Researchers have been hopeful that the development of manufactured antibodies would be the next big advance in battling the pandemic. Scientists around the world are still working out the exact role of neutralizing antibodies in recovery for COVID-19, but drugmakers, like Regeneron, are confident that the right combination can alter the course of the disease.
There are at least 70 different antibody treatments for COVID-19 under investigation.
Eli Lilly and Co., AstraZeneca, Amgen and GlaxoSmithKline have been cleared by the U.S. government to pool manufacturing resources to scale up supplies should any of their antibody drugs prove successful.
How many doses a patient would need is still not known.
Is it widely used?
Regeneron’s experimental treatment is currently being studied for use in patients with early illness.
It’s still in early large-scale clinical trials, according to the company. Initial results reported this week suggest the treatment can reduce the level of virus in the body, improve symptoms in non-hospitalized COVID-19 patients, and possibly shorten hospital stays, with no serious side effects. The trial was conducted on fewer than 300 people.
At this time, the treatment has not been authorized by the U.S. Food and Drug Administration (FDA).
However, it has been available for “compassionate use,” which means the FDA can approve it on an individual basis. That’s how Trump received the treatment.
The company has asked the FDA for emergency approval of the treatment, which Trump claims is “all set” and just needs to be signed off on.
Regeneron’s president, Dr. George Yancopoulos, told CNN the company is on track to deliver 300,000 doses of the drug by the end of the year, which Trump wants to distribute free of charge. The requested number of doses is still a far cry from the more than 2,500,000 active cases in the U.S.
While it’s not the first time the company has received the so-called compassionate use request, Yancopoulos said the “mechanism is not intended for widespread distribution.”
“Unlike a vaccine, which is given very broadly, trying to protect everybody, here this is a treatment that could be targeted to those patients who are sick,” he told CNN last week.
“You would give it in a targeted fashion.”
Costs also make this drug. It is free of cost to those participating in clinical trials and those granted a “compassionate use” exemption, like Trump, but it’s hard to manufacture.
If the treatment is approved to hit the commercial market, it could cost thousands of dollars.
What do experts say?
Data so far is limited for COVID-19 antibodies. Regeneron’s treatment is one of the most promising candidates, along with one being developed by Eli Lilly, but its use has come under scrutiny by doctors.
“Experimental drugs are by definition risky,” Dr. Edward Jones-Lopez, an infectious disease specialist at the Keck School of Medicine at the University of Southern California, told Reuters.
While some of the therapies for COVID-19 still under investigation are “promising,” they’re inevitably “uncertain,” said Dr. Isaac Bogoch, an infectious disease specialist based out of Toronto General Hospital.
“There was a small trial conducted using this Regeneron product, but the data from that trial is not yet available in a peer-reviewed medical journal.”
It’s the peer review that will find any holes or pitfalls, according to Dr. Richard Besser, a former acting director of the U.S. Centers for Disease Control and Prevention (CDC).
“I would withhold judgment on this until we see the data,” Besser told CNN. “You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”
However, U.S. infectious disease chief Dr. Anthony Fauci is among those saying the treatment has promise.
Concerns about preferential treatment provided to the president are also rife.
As one professor of medicine in California put it: “It is bad science, bad medicine and bad ethics to give unproven things to powerful people that you don’t give to average people,” Vinay Prasad tweeted on Oct. 2.
“VIP medicine doesn’t mean medicine when there is no data.”
What about Canada?
The treatment is not available in Canada, nor would it be “widely available globally,” said Bogoch.
“It would only be available in the context of a clinical trial,” he said.
There are two antibody-related treatment trials authorized by the government of Canada, according to its official online list. One is by GlaxoSmithKline and the other is out of the University of Calgary.
However, there are other Canadian scientists designing therapeutic antibodies, as well as tests, being developed and explored by companies and universities.
Prime Minister Justin Trudeau announced $275 million in funding for COVID-19-related research in March.
The Public Health Agency of Canada did not respond to a request for comment about the status of the treatment in Canada by the time of publication.
— with files from The Associated Press and Reuters