REGN Regeneron Pharmaceuticals Inc

   By Stephen Nakrosis 
 

Regeneron Pharmaceuticals Inc. on Tuesday said initial data from an ongoing Phase 1/2/3 clinical trial of its antibody cocktail in hospitalized Covid-19 patients requiring low-flow oxygen was "encouraging."

The company said its antibody cocktail is made up of casirivimab and imdevimab.

"The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial," that is, its futility analysis, Regeneron said. According to the company, "results passed the futility analysis, as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation."

Regeneron also said the Phase 3 program in hospitalized patients will continue "based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation."

The company also said it was the "first antibody therapy to demonstrate anti-viral effect in patients hospitalized with Covid-19."

George D. Yancopoulos, the company's president and chief scientific officer, 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." He also said, "The data from these trials in hospitalized and non-hospitalized patients suggest that Regeneron's antibody cocktail may compensate for an inadequate endogenous antibody response by reducing viral levels and the risk of adverse clinical outcomes."

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

December 29, 2020 17:29 ET (22:29 GMT)

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