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Regeneron Says Initial Data From COVID-19 Antibody Cocktail Trial Encouraging

Regeneron Pharmaceuticals, Inc. (REGN) announced Tuesday encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen.

The analysis focuses on patients who had not yet mounted their own immune response to SARS-CoV-2, i.e., did not have antibodies at baseline: seronegative, as prior evidence suggested these patients were at greater risk.

The primary clinical objective of the initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial, i.e., futility analysis.

The company noted that the results passed the futility analysis, as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation.

The benefit was driven by results starting one week post-treatment, when the risk of death or receiving mechanical ventilation was reduced by approximately half with antibody cocktail treatment, based on a post-hoc analysis.

George Yancopoulos, President and Chief Scientific Officer at Regeneron, said, "These preliminary results in hospitalized patients, as well as data from the previously announced outpatient trial, indicate that antibodies produced by a patient's own immune response are important to control COVID-19 infection. In this trial, patients who had not yet mounted their own immune response had much higher viral loads and much worse clinical outcomes; for example in the placebo group, seronegative patients were almost three-times more likely to die compared to seropositive patients."

In November, the Regeneron antibody cocktail was granted an Emergency Use Authorization by the U.S. Food and Drug Administration in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

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