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September 30, 2021

Regeneron’s REGEN-COV meets primary goal in Phase II/III Covid-19 trial

The latest data support the RECOVERY trial in the UK, which analysed the antibody cocktail in hospitalised patients.

Regeneron Pharmaceuticals has reported that its experimental antibody cocktail, REGEN-COV, met the primary goal of the Phase II/III clinical trial in hospitalised adult Covid-19 patients.

REGEN-COV is a combination of the two monoclonal antibodies casirivimab and imdevimab that can hinder SARS-CoV-2 infectivity.

Subjects in the randomised, double-blind, placebo-controlled Phase II/III trial were randomised into a 1:1:1 ratio to receive a one-time infusion of 8,000mg or 2,400mg of REGEN-COV or placebo.

According to the trial data, REGEN-COV substantially decreased the viral load within seven days in subjects who were enrolled without having mounted their antibody response (seronegative) and needed low-flow or no supplemental oxygen.

The trial results also support the large RECOVERY trial in the UK in hospitalised patients, with numeric improvements reported across all clinical goals evaluated.

A 36% reduced risk of mortality was observed within 29 days of receiving the REGEN-COV treatment in the overall population while the risk declined by 56% in subjects who were seronegative at baseline.

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In November 2020, the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the antibody cocktail to treat patients with mild to moderate Covid-19.

Indicated to treat certain adults and paediatric patients aged 12 years or above, the therapeutic can also be used in some post-exposure prophylaxis settings.

The FDA is currently reviewing the company’s request to add REGEN-COV for use in hospital settings to the EUA.

Regeneron president and chief scientific officer George Yancopoulos said: “These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalised with Covid-19.

“It’s important to remember that while results from this and the RECOVERY trial indicate that patients unable to develop their own antibodies against Covid-19 historically had the poorest prognosis – and hence the greatest benefit from REGEN-COV treatment – both were largely conducted before widespread vaccination or the emergence of variants such as Delta.”

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