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A new drug cancels all variants of the coronavirus. But regulatory hurdles and lack of investment make it unlikely to succeed in the U. S. market. In the U. S. in the short term.
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By Benjamin Müller
Over the past year, the arsenal of treatments for covid-19 in the U. S. has been in the U. S. UU. se has declined as new variants of the coronavirus have eroded the potency of one drug after another. Many patients are now left with only one option, Paxlovid. Although it is very effective, it causes disorders for many other people who want it due to harmful interactions with other medications.
But a new variety of variant-proof remedies can simply replenish the country’s arsenal. On Wednesday, scientists reported in the New England Journal of Medicine that a single injection of a drug called interferon halved the chances of hospitalization for a Covid patient.
The results, demonstrated in a clinical trial of nearly 2,000 patients, rivaled those obtained through Paxlovid. And interferon injections are even more promising, the scientists said. By strengthening the body’s own mechanisms for crushing an invading virus, they can potentially protect not only Covid, but also flu and other viruses that can cause pandemics in the long run.
“It doesn’t matter if the next pandemic is a coronavirus, a flu virus or some other respiratory virus,” said Eleanor Fish, an immunologist at the University of Toronto who was not interested in the new study. “For all the viruses we see circulating now, it’s helpful to use interferon. “
However, for all its promises, the drug, called pegylated lambda interferon, faces a dubious direction in the advertising market. to authorize it for emergency use. Eiger executives said part of the challenge gave the impression that the clinical trial didn’t come with a U. S. site. It was initiated and run by educational researchers, which the company itself.
Regulators have warned that only a giant clinical trial conducted at least partly in the US would suffice. A situation that would require several years and, in particular, more funding. An FDA spokeswoman said the disclosure legislation will save the firm from commenting.
These hurdles are indicative of problems that some experts say threaten the progress of a wide variety of next-generation covid remedies and vaccines, products that can cope with the constant number of covid and also give scientists an advantage in preparing for the next pandemic.
As things stand, Eiger executives have said they would possibly seek approval for interferon fired outside the United States. China, for example, has been looking for new treatment options.
Some scientists involved in the studies have expressed frustration that doctors still can’t prescribe the shots. Even though previous vaccines and infections helped involve the damage of the virus, Covid still kills about 450 Americans per day.
“I think it’s a far-fetched scenario that we’re still here now, 3 years after the pandemic, and I have a drug that I can prescribe hopefully to other people who are infected,” said Dr. Jeffrey Glenn, a virologist and director of a pandemic preparedness initiative at Stanford University. who helped lead the study of interferon injection. “We want more options. “
Dr. Glenn founded Eiger, owns shares in Eiger and serves on its board of directors, no longer working for the company.
Interferons are an organization of proteins that alert neighboring cells within hours of a virus invasion. The coronavirus, like other viruses, is clever at turning off the body’s herbal interferon response. Help patients outsmart the virus.
By focusing on patients’ immune responses, rather than the virus itself, those remedies potentially presented some other merit over existing remedies, reducing the threat of a variant that could resist the drug’s evolution, said Vineet Menachery, an immunologist at the University of Texas Medical Branch. . .
Several monoclonal antibodies are no longer used because they have stopped working against the new variants. Paxlovid has remained effective because the virus has a lot to move around, but it’s possible that new variants will one day make it less useful as well.
“I don’t know of any viruses that can navigate a mobile phone where interferon arrived first,” said Benjamin tenOever, a microbiologist at New York University’s Grossman School of Medicine.
However, taking advantage of those functions in a drug is easy. Interferons can cause far-reaching side effects, adding inflammation, a threat in covid cases because some patients have an overactive immune response.
“You’re telling your frame that you’re very inflamed with a virus and you have to fight, fight and fight at all costs,” said Juliet Morrison, a microbiologist at the University of California, Riverside.
Previous studies have tested interferon remedies only in patients who are already sick and hospitalized. This means that the drugs were administered too late, resulting in combined or disappointing results.
The scientists of the drug Eiger devised a clever solution.
When thinking about treatments for hepatitis, in the past they had acquired a drug based on lambda interferons, a lesser-known type of interferon whose receptors are largely limited to express areas, such as the airways. That’s exactly where the coronavirus was repeated. And that meant the side effects would theoretically be less intense than those of the maximum common-use elegance of interferons, whose receptors are distributed throughout the body.
These hopes were shown in the last essay. After administering the vaccine to about 900 patients and giving a placebo to 1,000 patients, the researchers did not discover a considerable difference in the occurrence of side effects, they said.
Vaccination prevented the vast majority of patients on either team from being hospitalized for prolonged periods or emergency room visits. But treating patients with interferon within a week of symptom onset halved their chances of being hospitalized: Another 25 people who won the vaccine were hospitalized, compared with 57 who had not been treated.
The effects were even more pronounced when the drug was administered within 3 days of symptom onset and when given to unvaccinated people. because they had an underlying disease or a weakened immune system.
And the drug appeared to work in all variants, appearing even more potent when Omicron was dominant, according to the study.
“Although the pandemic is less pressing than it was at its peak, we still see other people coming into the hospital and in very poor health with Covid,” said Dr. Jordan Feld, a viral hepatitis specialist at the University of Toronto. who co-authored the study and won Eiger’s investment. “Having solution functions to test to prevent this from falling out would be really helpful. “
Some researchers said they plan to test interferon-based drugs on others seeking treatment for a variety of respiratory viruses, such as influenza and RSV, or respiratory syncytial virus, which has put a lot of pressure on hospitals this winter. Doctors can even treat patients before they knew which virus was causing them problems.
Some studies have also suggested that the very elegance of drugs, if used temporarily enough, can prevent other people exposed to the virus from becoming inflamed in the first place.
“I suspect that the largest application of all those interferons will be in prophylactic treatment,” said Dr. Fish of the University of Toronto, “especially in outbreak settings for Americans at high risk of infection. “
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