Update: 4/13/2021: Regeneron Pharmaceuticals last year was awarded a $450 million contract to manufacture and supply an anti-viral antibody cocktail it had been developing for the treatment and prevention of COVID-19 infection. Now, after receiving FDA approval for public use, the cocktail is showing dramatic results in lessening symptoms of the disease.
The double antibody cocktail, called REGN-COV2, passed Phase 2 and 3 clinical trials for the treatment of COVID-19 and Phase 3 trials for the prevention of the virus last summer, before being granted compassionate care authorization to treat President Donald Trump, who tested positive for the virus in October following several “superspreader” events held at the White House. The Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense awarded this agreement to the biotechnology company as part of Operation Warp Speed, the program to fast track the nation’s coronavirus response.
New Phase 3 trial data released this week show that a single shot of the cocktail was able to prevent symptomatic COVID-19 in 81% of test cases, where 1,505 patients had not already been infected by the virus but were living in the same household as someone who tested positive. The cocktail proved 72% effective in the first week and subsequently 93% effective in following weeks. After 29 days, only 11 subjects developed any COVID-19 symptoms and none required hospitalization.
Adverse reactions were seen in fewer subjects than in a placebo group (20% versus 29%), and of four deaths during the trial (two from each group) none were related to either COVID-19 or the drug.
Additionally, a separate Phase 3 trial in 204 asymptomatic infected persons showed a 31% reduction in risk of disease progression, increasing to 76% after three days and shortening both the duration and severity of symptoms.
REGN-COV2 was made available immediately in the United States following its successful Phase 2 and 3 clinical trials among hospitalized patients, and the U.S. Food and Drug Administration (FDA) granted its sign-off. Since early last spring, Regeneron preemptively began increasing manufacturing of the cocktail — a combination of two potent, non-competing and virus-neutralizing antibodies — using the same method it developed for rapid development of a highly-effective novel Ebola treatment last year.
Leonard S. Schleifer, M.D., Ph.D., Co-Founder, President and CEO of Regeneron, says the company’s thirty years of investment in this type of antibody discovery and development technology have enabled them to move quickly on the REGN-COV2 program.
“We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted,” he says. “This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.”
The contract covers a fixed number of bulk lots for fall of 2020: 30,000 doses of the drug began shipping on the order of the Department of Health & Human Services, with 300,000 additional doses by the end of January 2021. An additional 420,000 to 1.3 million preventative doses were then slated farther down the line. The government is responsible for making doses from these lots available to Americans at no cost.