New Phase 3 trial data finds a single shot of Regeneron’s Covid-19 antibody cocktail was able to prevent symptomatic Covid-19 among people exposed to the virus, the company said on Monday.
Regeneron, in its statement, said that it will seek expansion of the emergency use authorization for the drug, which is currently available in the United States to treat mild-to-moderate Covid-19 in people already infected with the coronavirus.
“The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg administered subcutaneously (SC) reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial,” the company said.
According to The Hill, the company has already received emergency use authorization from the FDA to use its antibody drugs to treat adults with mild to moderate COVID-19 and pediatric patients at least 12 years old who have tested positive for the virus and are at high risk of severe disease but are not yet hospitalized.
The trial enrolled 1,505 people who were not infected with SARS-CoV-2 at baseline and randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo, administered as SC injections.
The Phase 3, double-blind, placebo-controlled trial assessed the effect of REGEN-COV on uninfected individuals without anti-SARS-CoV-2 antibodies or any COVID-19 symptoms, who lived in the same household as an individual who tested positive for SARS-CoV-2 within the prior 4 days.
After 29 days, 11 people out of the 753 who received a single 1,200 mg dose of the treatment developed symptomatic COVID-19; 59 people who received a placebo out of 752 participants developed symptomatic COVID-19.
The drug provided 72 percent protection against symptomatic infections in the first week and 93 percent protection in subsequent weeks, Regeneron said. The data has not yet been peer-reviewed or published, as reported by The Hill.
Regeneron also said the trial found individuals treated with the therapy who experienced asymptomatic infection resolved their symptoms in one week, compared to three weeks with placebo.
Infected individuals also cleared the virus faster with the therapy, the company said.
Adverse events occurred in 20 percent of patients who received the antibody-drug and 29 percent of those who received a placebo, Regeneron said, but nobody withdrew from the trial because of them, The Hill reported citing the company’s statement.
None of the participants who received the therapy were hospitalized or went to the ER because of COVID-19 over the course of 29 days; four in the placebo group did so. However, there were four deaths in the trial — two in the therapy group and two in the placebo group — but none were reported due to COVID-19 or the drug.
The Hill further reported that The trial tested the antibody treatment for use as a “passive vaccine,” which involves directly injecting antibodies into the body. Traditional vaccines rely on a person’s immune system to activate and develop its own antibodies.
That means the treatment may provide immediate benefits, in contrast to active vaccines, which take weeks to provide protection. In addition, using injections rather than an infusion could make administering it more convenient than the currently authorized use for antibody drugs, according to the news outlet.
CNN reported that Eli Lilly and Company previously announced its monoclonal antibody therapy, bamlanivimab, helped prevent symptomatic Covid-19 infection among nursing home residents and staff.
However, the US government said last month it will no longer distribute bamlanivimab for use on its own because of a sustained increase in coronavirus variants in the United States.Bamlanivimab can still be used with etesevimab, another monoclonal antibody treatment developed by Eli Lilly; in combination, the two Eli Lilly treatments seem to work against coronavirus variants.
So far, Regeneron’s cocktail has been shown to be effective against coronavirus variants of concerns, as reported by CNN.
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