After receiving emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19, Regeneron Pharmaceuticals (NSDQ:REGN) has announced promising early results in an ongoing trial involving hospitalized patients needing low-flow oxygen.
Focusing on patients who had not yet developed an immune response to SARS-CoV-2, the trial found that patients who received the antibody cocktail had approximately half the risk of death or requiring mechanical ventilation one week after treatment.
The institutional review board has permitted the Phase 1/2/3 study to continue after it passed a futility analysis.
The study also revealed a difference in performance between seronegative patients (who lacked antibodies to SARS-CoV-2) and seropositive patients (who had developed antibodies to the novel coronavirus).
While the benefits for seronegative patients were clear, seropositive patients receiving the antibody cocktail had more modest improvements.
“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,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron in a statement.
Yancopoulos expressed optimism that the company’s antibody cocktail could “compensate for an inadequate endogenous antibody response by reducing viral levels and the risk of adverse clinical outcomes.”
Yancopoulos stressed that the clinical efficacy data thus far is based on a small data set.
The ongoing RECOVERY trial in the U.K. has enrolled more than 2,000 hospitalized patients in an arm testing the antibody cocktail against the standard of care.
Federal officials are apparently disappointed that the monocolonal antibodies from Regeneron and Eli Lilly (NYSE:LLY) have thus far found limited use after winning EUA, according to a report from NPR.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development
