A new COVID-19 drug reduced high-risk patients’ risk of hospitalization by 50%, according to a large new clinical trial, and slashed the risk of death by 60%.
Its maker is now seeking FDA authorization — meaning we could soon have another weapon in our arsenal against COVID-19.
The challenge: It’s been two years since the pandemic started, and the U.S. is still reporting tens of thousands of new cases every day. The virus has mutated into more infectious variants that also partially evade antibodies, and it’s become clear to experts that we’re probably never going to get rid of COVID-19.
“If you look at the history of infectious diseases, we’ve only eradicated one infectious disease in man, and that’s smallpox,” Anthony Fauci, the top White House medical adviser, said in January. “That’s not going to happen with this virus.”
It’s become clear to experts that we’re probably never going to get rid of COVID-19.
The need: Effective vaccines can help protect us from infection and prevent mild cases of COVID-19 from becoming severe, but we also need a variety of effective treatment options, and so far, the FDA has only issued emergency use authorizations for three.
Those drugs were trialed when older COVID-19 variants were dominant, so we don’t know for sure how effective they are against new strains.
They were also tested before COVID-19 vaccines were widespread. That means we don’t know if the 76% of Americans who have received at least one shot would benefit from the drugs as much as trial participants — it’s possible the vaccines already lower risk as much as possible.
Hundreds of other treatments are in the works, though, and the next COVID-19 drug to cross the development finish line could be Eiger BioPharmaceuticals’ Peginterferon Lambda (Lambda).
How it works: Lambda works by stimulating immune responses that help the body fight off infection, without causing inflammation. It’s administered in a single subcutaneous injection (which is typically less painful than the intramuscular injections used to administer vaccines).
Eiger has now shared results from a phase 3 study of Lambda that involved nearly 2,000 non-hospitalized, adult COVID-19 patients at high-risk of developing severe illness. Nearly 85% of participants had received at least one COVID-19 vaccine.
Lambda is administered in a single subcutaneous injection, which is typically less painful than the shots used for vaccines.
According to the company, the risk of hospital admission or ER visits longer than six hours was reduced by 50% when patients received one dose of Lambda within 7 days of symptom onset.
If the COVID-19 drug was given within 3 days, the risk of hospitalization was reduced by 60%.
Viral sequencing of patients’ infections revealed that the drug met this endpoint for all COVID-19 variants tested, including Omicron.
In addition to meeting its primary endpoint of reducing hospitalization, Lambda also cut patients’ risk of death by 60%, with only one patient in the treatment group dying compared to four in the placebo group.
Reports of adverse events, such as injection site reactions, were similar between the treatment and placebo groups.
Looking ahead: The results of the phase 3 trial have yet to be published or peer-reviewed, but Eiger has said it plans to submit the data for review by the FDA in the hope of securing an emergency use authorization for Lambda.
“These data demonstrate that a single subcutaneous injection of Lambda has the potential to be a convenient, ‘one and done’ treatment to reduce the severity of COVID-19, reducing hospitalizations and death — even in a vaccinated population,” said Eiger President and CEO David Cory.
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