The COVID drug shows promise in a new study – but will patients ever get access?
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A drug aimed at curbing severe COVID-19 is causing excitement among scientists given the limited treatment options that remain to fight serious infections – but some doubt it will ever reach patients.
Canadian research on the drug called pegylated interferon lambda is just the latest chapter in a year-long saga to find effective COVID treatments that’s filled with promising prospects, regulatory roadblocks, and ultimately a slew of dead ends as many drugs have proven powerless against this ever-evolving virus.
Monoclonal antibodies once thought to be life-saving are no longer effective against new variants – leaving Pfizer’s multi-pill antiviral drug Paxlovid as one of the last tools in the toolbox.
The researchers’ renewed hope centers on a different type of drug based on a specific type of interferon — a substance typically made by the body’s cells to help the immune system fight infections — that fights various diseases seems to claim variants of SARS-CoV-2.
A study by 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 the drug reduced the risk of hospitalization.
The randomized clinical trial included nearly 2,000 participants, mostly from Brazil and some from Toronto, and took place between June and March 2021.
The majority of the subjects, around 84 percent, had previously been vaccinated against COVID-19.
“What we saw is that a single dose of treatment reduced the likelihood that people at high risk of severe COVID will require hospitalization with their disease by about 50 percent in vaccinated people,” said UHN researcher Dr. Jordan Feld.
“And in people who weren’t vaccinated, the effect was greater – almost a 90 percent reduction.”
dr Donald Vinh, an infectious disease specialist at McGill University, called the drug’s potential “amazing” during an email exchange with CBC News, “because it shows we can harness the power of the immune system and enhance its protection against infection.” , and with relatively few side effects.”
The drug would also be easy to administer, as it’s just a single injection into the skin, similar to an insulin shot – something patients could even do themselves if needed.
It is far less clear whether patients will even get the drug.
The drug has interferon that targets the lungs
The specific type of interferon studied by the Canadian research team uses a receptor found only 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 sets it apart from previous studies looking at the effects of other, broader interferons that work throughout the body. These also boost an immune response, but can also stimulate dangerous inflammation.
For example, another World Health Organization-backed team conducted a study of hospitalized COVID patients early in the pandemic, which found that another interferon was actually linked to it worse Results, said BC-based clinical scientist Dr. Srinivas Murthy who helped with this research.
“We need to make sure it’s the right interferon and the right patient population, and so the availability and accessibility of this product is an important consideration,” he added.
Currently, the interferon showing potential against COVID, pegylated interferon lambda, is not available to Canadian patients. It’s been previously studied in the context of hepatitis viruses, Feld noted, but it’s “not actually approved for use in other indications.”
Feld is hopeful that one day the drug will be able to weave its way through the regulatory process to gain approval for use.
However, Murthy is “more skeptical”.
“It’s not really a used drug in Canada, the US or anywhere else,” he said. “And what needs to happen is that — compared to the other drugs that we’ve been thinking of for COVID-19 that have been repurposed — this has to go through all the approval mechanisms and so on.”
The FDA has not approved the emergency
That’s where it gets tricky. Late last year, U.S. Food and Drug Administration (FDA) regulators told the company behind the drug, Eiger Biopharmaceuticals — which helped fund the new study into its use against COVID — that they were “not ready to use it for to authorize the emergency,” the New York Times recently reported.
“Regulators suggested that just a large clinical trial, conducted at least partially in the United States and with more corporate involvement, would be sufficient, Eiger executives said, a scenario that would require several years and significantly more funding.” , the Times story continued .
dr Paul Sax, clinical director for infectious diseases at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said regulatory discussions around the drug had gone “totally silent” for several months.
“I was kind of worried it was going to die off,” he said, “and then this study came out.”
Health Canada, Murthy said, typically “doesn’t stray too far” from the FDA’s approach.
“Normally for new drugs we would need a few trials with reliable endpoints,” he said.
CLOCK | At one of Canada’s hardest hit hospitals during the third wave of COVID-19:
High-risk individuals may be looking for new treatment options
It’s also worth arguing that at this point in the pandemic — given access to vaccines that can largely prevent serious illnesses in the first place — there simply isn’t the same need for additional treatment given the shrinking rate of people who are dying because of COVID require hospitalization, Murthy said.
However, Sax emphasized that high-risk individuals are still looking for new options.
A single shot might be easier for some people than Paxlovid’s multi-day pill regimen. And immune-based interferon therapy may provide a variant-safe treatment, unlike monoclonal antibodies, which target the virus’s spike protein – rendering them ineffective if this site continues to mutate.
For now, pegylated interferon lambda remains a promising option, even though “we can’t give anyone this therapy tomorrow,” Feld said.
“Some people… they saw the release and they said to me, ‘Can we get this?'” he said. “And unfortunately I didn’t say it yet. I hope soon – but not yet.”