Regeneron announces initial clinical data for COVID-19 antibody cocktail
pharmafile | December 18, 2020 | News story | Medical Communications | COVID-19, Regeneron, antibody
Regeneron Pharmaceuticals has announced that initial clinical data published in the New England Journal of Medicine shows that its antibody cocktail of casirivimab and imdevimab “effectively reduced viral load” in non-hospitalised COVID-19 patients.
Dr David Weinreich, Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication, said the Phase I/II/III trial of the treatment showed that “casirivimab and imdevimab effectively reduced viral load and the need for medically-attended visits, with the greatest benefit in patients who had not yet mounted their own effective immune response or had high viral load at baseline”.
He added: “The investigational cocktail is now available to indicated high-risk US patients under an Emergency Use Authorization, and we also continue a robust clinical development programme.”
The US biotechnology company previously announced the initial results from the Phase I/II portion of the trial, that enrolled 275 patients randomised 1:1:1 to receive 8 grams casirivimab and imdevimab, 2.4 grams casirivimab and imdevimab or placebo. Approximately 56% of patients were Latino/Hispanic, 13% were Black/African American and 64% had one or more underlying risk factors for severe COVID-19, including obesity (more than 40%).
Regeneron also announced additional prospective results in a total of 799 patients from the trial. In both the initial descriptive analyses of 275 patients, as well as in the following prospective analyses involving a total of 799 patients, a greater effect was observed in patients treated with the antibody cocktail who had not yet built up an effective immune response (‘sero-antibody-negative’) or who had high viral load at baseline.
In the initial 275 patients, rates of adverse events (AEs) were similar among groups; serious AEs occurred in two placebo patients, one low-dose patient and no high-dose patients. The AEs reported included infusion-related reactions (one placebo patient, no low-dose patients, two high-dose patients) and hypersensitivity reactions (two placebo patients, no low-dose patients, one high-dose patient).
Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron, said: “These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention.
“We are continuing to evaluate our antibody cocktail in this outpatient setting, as well as in late-stage trials in hospitalised patients and for prevention of infection, and will continue to share our findings as quickly as possible.”
Darcy Jimenez
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