COVID-19: Regeneron to seek US approval for antibody cocktail, says 'reduces symptoms'

Regeneron will seek US approval for its COVID-19  antibody cocktail as a “preventative treatment” against symptomatic COVID-19 infection. In its second Phase III trial undertaken in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), it was found that the administration of REGEN-COV shortened symptom duration and markedly reduced viral levels, the pharmaceutical company said in a statement. It also added that the antibody cocktail reduced the risk of symptomatic infections in households where there was a cover positive patient.

The trial enrolled 204 individuals without any COVID-19 symptoms who tested positive for SARS-CoV-2. These patients did not have anti-virus antibodies and were randomized to receive 1 dose of REGEN-COV (1,200 mg). It was found that the total number of weeks patients experienced symptoms was nearly cut in half (45 percent) with REGEN-COV. The anti-body cocktail uses the combination shot of casirivimab and imdevimab. 

"COVID-19 transmission often occurs via infected people who do not yet have symptoms, so it is critical that we rapidly diagnose and treat these individuals for their own health and to prevent transmission," said Katharine Bar, M.D., co-principal investigator of the trial. "These data pave the way for REGEN-COV to be used before patients become symptomatic, with a more convenient subcutaneous administration,” she added.

Touted by former US President Trump

REGEN-COV reduced progress of symptomatic COVID-19 into a severe infection by 31 percent, and by at least 76 percent after the third day. As it seeks to attain approval for wider use, the company has cited that its Switzerland's Roche and another biotech facility in South San Francisco would manufacture close to 2 million doses. The drug has the emergency authorisation use from the US FDA for mild to moderate COVID-19 cases. It said that the trial results showed that the potion reduced the viral load by 90 percent. “Researchers also found that there were zero REGEN-COV patients either hospitalized or visited the emergency room because of COVID-19 during the 29-day assessment,” the drugmaker said. The antibody cocktail was widely touted by the former US President Donald Trump, who was given the potion in course of his recovery from COVID-19 infection. 

"These Phase III data provide even more evidence that REGEN-COV, this time given to asymptomatic patients via convenient injections, can change the course of COVID-19 infection in non-hospitalized patients," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. 

(Image Credit: AP)