Regeneron Pharmaceuticals Inc.’s (REGN) antibody cocktail REGEN-COV was effective in preventing COVID-19 in people at high risk of infection, as per an interim results from a late-stage study.
As per the interim analysis of 409 people participating in a phase 3 trial, REGEN-COV (casirivimab and imdevimab antibody cocktail) caused a 100% prevention of symptomatic infection and about 50% lower overall rates of infection.
“These data using REGEN-COV as a passive vaccine suggest that it may both reduce transmission of the virus as well as reduce viral and disease burden in those who still get infected,” said George Yancopoulos, President and Chief Scientific Officer at Regeneron.
The company said it looks forward to seeing the full dataset early next quarter and will discuss the current results with regulatory authorities, including the potential to expand the Emergency Use Authorization.
Regeneron’s COVID-19 antibody therapy REGN-COV2 received emergency use authorization in November from the U.S. Food and Drug Administration.
The company said Tuesday that the REGEN-COV antibody cocktail may be able to help break the virus spreading chain by providing immediate passive immunity to those at high risk of infection, in contrast to active vaccines which take weeks to provide protection. The antibody cocktail could be effective both as a therapeutic and as a passive vaccine.
The company noted that that the REGEN-COV Phase 3 prevention trial evaluated the use of REGEN-COV as a “passive vaccine” to prevent SARS-CoV-2 infection. Passive vaccination provides immediate short-term passive immunity, by delivering protective virus-neutralizing antibodies, either through therapeutic antibody medicines like REGEN-COV or from mother to child through breastmilk.
Traditional vaccines work by activating the immune system to develop its own antibodies, a process that typically takes weeks, but provides longer-term active immunity.
The initial descriptive analysis included 409 evaluable participants enrolled early in the trial who did not have COVID-19 at baseline and were “seronegative,” meaning they did not have existing antibodies in their blood to SARS-CoV-2. Individuals were eligible for the trial if they had a household member with COVID-19.
Participants were tested weekly by nasopharyngeal swab. The confirmatory results will evaluate the ability of REGEN-COV to prevent asymptomatic and symptomatic COVID-19 infections as the primary endpoint. The trial has enrolled over 2,000 participants.
In addition, REGEN-COV is being studied in two late-stage hospitalized patient trials and a Phase 3 trial for the treatment of non-hospitalized patients.
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