Regeneron announced positive results from its late stage COVID-19 outpatient trial, indicating that its antibody cocktail therapy significantly reduced virus levels and need for further medical attention. The trial results showed that investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints.
The biotechnology company has shared these results with the U.S. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2.
Following the news, Regeneron shares were gaining around 2.3 percent in pre-market activity on Nasdaq, and were gaining 4 percent in France.
REGN-COV2 is a combination of two monoclonal antibodies, such as REGN10933 and REGN10987, and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting is measuring the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care.
In the trial, REGN-COV2 significantly reduced viral load and patient medical visits, including hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits.
The initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes.
The latest trial data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits.
On the key clinical endpoint, treatment with REGN-COV2 reduced COVID-19 related medical visits by 57 percent through day 29, and by 72 percent in patients with one or more risk factor.
Regeneron said the Phase 3 portion of this trial continues in non-hospitalized patients.
REGN-COV2 is also being studied in a Phase 2/3 clinical trial for the treatment of COVID-19 in hospitalized patients, the Phase 3 open-label RECOVERY trial of hospitalized patients in the UK and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
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