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A drug to curb severe COVID-19 is exciting scientists, given the limited remedies left to fend off serious infections; However, some doubt that it will ever succeed in patients.
Canadian drug research, called pegylated lambda interferon, is just the latest bankruptcy in a multi-year saga to locate effective treatments for COVID, which has been filled with promising prospects, regulatory hurdles and, in the end, a series of dead ends like many drugs have. He is powerless in the face of this ever-evolving virus.
Monoclonal antibodies, which once saved lives, no longer oppose the new variants, leaving Pfizer’s multi-pill antiviral drug Paxlovid as one of the last pieces of equipment in the toolbox.
The researchers’ renewed hope centers on some other type of drug based on an express form of interferon, a substance that is usually produced through the body’s own cells to help the immune formula fight infection, which appears to be resistant to SARS-CoV-2 variants. .
A through researchers from McMaster University in Hamilton and the University Health Network (UHN) in Toronto, published this week in the New England Journal of Medicine, found that the drug reduced the threat of hospitalization.
The randomized clinical trial involved only about 2,000 participants, mostly from Brazil and some from Toronto, and took place between June and March 2021.
Most of the subjects, about 84%, had already been vaccinated against COVID-19.
“What we saw was that a single dose of the remedy reduced the likelihood that other people at higher risk for severe COVID would end up hospitalized for their illness by about 50 percent in other vaccinated people,” said UHN researcher Dr. Jordan. . Feld.
“And in unvaccinated people, the effect is greater: almost a 90 percent reduction. “
Dr. Donald Vinh, an infectious disease specialist at McGill University, called the drug’s prospect “incredible” in an email exchange with CBC News, “because it shows that we can harness the strength of the immune formula and develop it to provide opposite coverage. “to infection, and to do so with few side effects. “
The drug would also be undeniable to administer, as it is a solitary injection into the skin, much like an insulin injection, anything patients can do for themselves, if needed.
What’s much less transparent is whether patients will get the drug in the first place.
The express form of interferon studied by the Canadian study team uses a receptor found in certain parts of the body, primarily the lungs and liver, Feld said. (His interest in the drug stems from his major work as a liver disease researcher. )
This is what sets it apart from previous studies looking at the effect of other, broader interferons, which act throughout the body. These also speed up an immune response, but they can also stimulate harmful inflammation.
For example, another World Health Organization-backed team conducted a pre-pandemic study on hospitalized COVID patients, which found that another interferon was linked to worse outcomes, said Dr. Srinivas Murthy, a B. C. -based physician and scientist. He helped with that research.
“We want to make sure this is the right interferon and the right patient population, so the availability and accessibility of this product is a consideration. “
Currently, the prospective interferon for COVID, pegylated lambda interferon, is not available for the treatment of Canadian patients. It has already been studied in the context of hepatitis viruses, Feld noted, but “is not approved for use in other indications. “”
Feld hopes the drug will one day make its way through the regulatory procedure to get approval for use.
Murthy, however, is “skeptical. “
“It’s not a drug that’s used in Canada, the U. S. and Canada. “I would be in the U. S. or anywhere else,” he said. So what should happen is that, compared to the other drugs we have for COVID-19, which have been repurposed. “– it has to go through all the approval mechanisms and so on. “
This is where things get complicated. Late last year, U. S. Food and Drug Administration regulators were able toThe U. S. Food and Drug Administration (FDA) told the drug’s company, Eiger Biopharmaceuticals, which helped fund the new study on its use against COVID, that they were “not in a position to authorize it for emergency cases. “use,” the New York Times recently reported.
“Regulators have warned that a giant clinical trial conducted at least partly in the U. S. would suffice. “The U. S. government and with greater corporate involvement,” Eiger executives said, “a situation that would require several years and much more funding,” the Times article continued.
Dr. Paul Sax, clinical director of infectious diseases at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, said regulatory discussions around the drug were “totally silent” for several months.
“I was a little worried that they would let me languish,” he said, “and then this study came out. “
Health Canada, Murthy said, “usually doesn’t stray too far” from the FDA’s approach.
“Normally, for new drugs, we would want some trials with reliable parameters,” he said.
WATCH | Inside one of the hardest-hit hospitals in Canada, the third wave of COVID-19:
It can also be argued that at this point in the pandemic, given access to vaccines that can largely spare you a serious illness in the first place, there simply isn’t the same point of need for additional treatment, given the reduction. rate of other people requiring primary hospitalization for COVID, Murthy said.
Sax, however, under pressure that other high-risk people are looking for new options.
A single vaccine may be easier, for some people, than Paxlovid’s multi-day tablet regimen. And an interferon-based immune treatment can provide variant-proof treatment, unlike monoclonal antibodies that targeted the virus’ spike protein, rendering them useless as that dominance continues. mutate
For now, pegylated lambda interferon remains a promising possibility, even if “we can’t give this treatment until tomorrow,” Feld said.
“Some people . . . They saw the post and asked me, ‘Can we have this?'” he said. “And I said, unfortunately, still. I hope soon, still. “
Senior Health and Medical Journalist
Lauren Pelley covers fitness and medical sciences for CBC News, adding the global spread of infectious diseases, Canadian fitness policy and pandemic preparedness. In: lauren. pelley@cbc. ca
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