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www.fdanews.com/articles/199057-regenerons-investigational-covid-19-antibody-added-to-uk-recovery-trial

Regeneron’s Investigational COVID-19 Antibody Added to UK Recovery Trial

September 15, 2020

Regeneron Pharmaceuticals’ investigational COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial aimed at finding effective treatments.

The phase 3 trial will evaluate the effects of REGN-COV2 in addition to standard of care compared to standard of care alone in 4,000 hospitalized COVID-19 patients. The antibody cocktail is the first specifically designed COVID-19 treatment to be evaluated in the trial.

REGN-COV2 is the first treatment specifically designed for COVID-19 to be evaluated in the RECOVERY trial, which was originally started to determine whether existing treatments can be repurposed to treat the disease.

The study is the fourth late-stage trial of REGN-COV2 to date. The drug is currently in phase 3 testing in the U.S. for prevention of COVID-19 infections, and in two other large-scale phase 2/3 trials for patients already infected with COVID-19 (DID, July 7).

In July, Regeneron received a $450 million contract from HHS’ Biomedical Advanced Research and Development Authority and the Department of Defense to manufacture and supply the antibody cocktail. It was the first contract under the administration’s Operation Warp Speed granted to a therapeutic (DID, July 8).

The RECOVERY trial has already provided some beneficial insights on the use of existing drugs as COVID-19 treatments. For example, it found that the corticosteroid dexamethasone reduced deaths by one-third in COVID-19 patients on ventilators. Those findings led to the widespread use of corticosteroids for the most severe COVID-19 patients (DID, Sept. 3). — Jordan Williams