Regeneron’s COVID-19 Antibody Therapy Cuts Viral Load, Medical Visits

Data from Regeneron’s phase 2/3 trial of its COVID-19 antibody cocktail showed the treatment significantly reduced viral load and the number of medical visits needed by nonhospitalized patients, the company said Thursday.

Regeneron said the latest results, which involved an additional 524 patients enrolled in the trial, “provides definitive final virology results and meets the clinical endpoint of reducing medical visits.” The results showed that the antibody cocktail cut medical visits by more than half — 57 percent — through day 29.

The new analysis shows that REGN-COV2 “can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention," said George Yancopoulos, Regeneron’s president and chief scientific officer.

Because the findings showed no significant efficacy differences between the treatment’s 8-gram high dose and 2.4-gram low dose, the company is reviewing potential changes to dosing in the ongoing trial in order to help preserve limited supply. Regeneron has partnered with Roche to ramp up manufacturing of the antibody cocktail (DID, Aug. 20), and the biotech expects to produce enough doses to treat approximately 300,000 patients in the next few months.

The positive trial data have been shared with the FDA, which is currently reviewing Regeneron’s Emergency Use Authorization (EUA) application for the low dose of the antibody cocktail for the treatment of high-risk adults with mild-to-moderate COVID-19 infections.

The initial study data from 275 patients made a strong case that Regeneron’s antibody cocktail could lower viral load and potentially improve clinical outcomes. That data were announced at the end of September (DID, Sept. 30).

The promising COVID-19 treatment is also being evaluated in a phase 2/3 trial for hospitalized patients, a phase 3 trial for preventing infections in household contacts of infected patients and in the phase 3 RECOVERY trial of hospitalized patients in the UK.

The investigational therapy was given to President Trump as part of his treatment regimen for COVID-19, which he contracted earlier this month (DID, Oct. 5). — James Miessler