Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.
Regeneron’s REGN-COV2 met primary and key secondary end points in its phase 2/3 trial evaluating the drug in the COVID-19 outpatient setting.
Regeneron’s investigational antibody cocktail, REGN-COV2, significantly reduced virus levels and need for further medical visits in patients with coronavirus disease 2019 (COVID-19), according to results from a phase 2/3 trial.
REGN-COV2, a combination of monoclonal antibodies REGN10933 and REGN10987, was designed specifically to block infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In the ongoing phase 2/3 seamless trial in the COVID-19 outpatient setting, REGN-COV2 met the primary and key secondary end points, according to the findings. The randomized, double-blind trial is evaluating the effect of adding REGN-COV2 to usual standard of care, compared with adding placebo to standard-of-care.
The latest data from the trial include an analysis of 523 patients, in addition to data from the first 275 patients which was previously reported.
According to the results, the most recent analysis demonstrated that the trial met all of the first 9 end points in the statistical hierarchy, which assessed virologic end points based on viral load, seronegative status and dose group, as well as the key clinical end point of COVID-19 related medically-attended visits.
The virologic results showed:
The clinical results in the overall population:
Investigators noted that the results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams). Regeneron said that it is reviewing potential changes to dosing in the ongoing outpatient trial given the current limited supply of the drug.
REGN-COV2 was generally well tolerated in the trial, with more frequent severe adverse events (AEs) in patients treated with REGN-COV2 versus placebo. More infusion reactions occurred with the high-dose REGN-COV2 compared with placebo (1.5% high dose, 0% low dose, 0.4% placebo).
“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in a statement.
According to Yancopolous, Regeneron has shared the results with the FDA as part of its review of REGN-COV2’s emergency use authorization (EUA) submission and plans to submit detailed results of the trial for publication.