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Regeneron terminates four clinical trials of its COVID-19 antibody cocktail REGEN-COV

The drug was taken off the US market in January due to it being ‘highly unlikely’ to be active against the Omicron variant

Regeneron

Regeneron has ended four clinical trials of its monoclonal antibody combination, REGEN-COV (casirivimab and imdevimab), according to the federal clinical trial database.

The terminations follow the US Food and Drug Administration’s (FDA) revision of the REGEN-COV’s Emergency Use Authorisation (EUA), having taken it off the market in January due to the high frequency of the Omicron variant and the data showing that the drug is ‘highly unlikely’ to be active against this variant.

Months before the revision in September 2021, the company announced it had secured a deal with the US government to supply an additional 1.4 million doses of REGEN-COV at a cost of $2,100 per 1,200mg dose, bringing the US government’s order total to nearly three million doses.

The terminated studies include testing the drug’s use as a treatment for high-risk paediatric patients under 12 years of age, for the prevention of COVID-19 in immunocompromised adolescents and adults, as a treatment for paediatric patients hospitalised due to the virus and as a treatment for ambulatory patients.

All four studies, which ranged from phase 1 to phase 3, cite ‘emerging SARS-CoV-2 variants impacting susceptibility to study drug’ as the reason for termination, according to recent updates to the federal clinical trial database.

The treatment, which first became available to US patients in November 2020, is a cocktail of two monoclonal antibodies designed specifically to block infectivity of SARS-CoV-2.

The two virus-neutralising antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants.

Regeneron invented the antibody cocktail and is collaborating with Roche, the company that is primarily responsible for development and distribution outside the US, where it is known as Ronapreve.

The FDA has also extended its review of the Biologics Application (BLA) by three months for REGEN-COV to treat COVID-19 in non-hospitalised patients and as prophylaxis in certain individuals. The extension, which has surpassed its target action date of 13 July 2022, is a result of ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review.

Article by
Emily Kimber

2nd August 2022

From: Research, Healthcare

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