A formulation of SARS-CoV-2 Spike protein-neutralising antibodies.
Emergency use authorization
On November 21, 2020, the FDA issued an Emergency Use Authorization (EUA) for emergency use of REGEN-COV (casirivimab and imdevimab,
administered together) for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARSCoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
On March 23, 2021, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients. The Phase 3 trial shows that the REGEN-COV™ (casirivimab with imdevimab) antibody cocktail reduced hospitalization or death by 70%.
On August 20, 2021, the MHRA has issued a Conditional Marketing Authorisation for REGN-COV2 (Ronapreve) in Great Britain and a temporary regulation authorisation for Northern Ireland.
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In vitro and in vivo preclinical studies predict REGEN-COV protection against emergence of viral escape in humans
|HEK293T cells, hamsters||
This study demonstrates that a combination of noncompeting antibodies not only provides full coverage against currently circulating variants but also protects against emergence of new such variants and their potential seeding into the population in a clinical setting.
SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies
Antibody In vitro Mixed substance Peptide RNA Small molecule Spike protein
|Caco-2 cells; Vero cells; Sera of vaccinated individuals; (VSV) SARS-CoV-2 Spike-pseudotyped virus (WT, B.1.1.7, B.1.351, ant P.1 variants)||38.64||
REGN-COV2 displayed in vitro inhibition of SARS-CoV-2 Spike-pseudotyped virus infection for all tested emergent Spike variants (B.1.1.7, B.1.351, and P.1).
REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
Antibody Mixed substance Phase I clinical trial Phase II clinical trial Randomized controlled double-blind trial Spike protein
The antibody cocktail was generally well tolerated and reduced viral load in COVID-19 outpatients, especially those with high viral loads at baseline and patients whose immune response had not been initiated at the time of antibody administration. Sample size: 84 (high dose) + 80 (low dose) + 88 placebo (completed the trial). Dosage: 2.4 g (low) or 8 g (high). Endpoints: Change in viral load; proportion of patients with a COVID-19-related hospital visit by day 29.
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|NCT04617535||Compassionate Use of REGN-COV2 for the Treatment of COVID-19||Available||Jan/01/1970||Jan/01/1970|