October 30, 2020 -- Regeneron Pharmaceuticals Inc. announced Wednesday that its coronavirus antibody cocktail reduces virus levels and the need for additional COVID-19 medical visits.

The company shared the results with the FDA, which is reviewing an emergency use authorization for the treatment for high-risk adults with mild or moderate COVID-19.

“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, president and chief scientific officer of Regeneron, said in a statement.

Regeneron is testing the treatment in patients in an ongoing phase II/III clinical trial. President Donald Trump received the antibody cocktail while in the hospital earlier this month.

In Wednesday’s update, which included 800 patients, the treatment led to 57% fewer COVID-19 medical visits as compared with those given a placebo, including hospitalizations, emergency room visits, urgent care visits and telemedicine visits. About 2.8% of those given the antibody saw a health care worker within 29 days, as compared with 6.5% of those who received the placebo.

The drop was around 72% for those with one or more risk factors, including those who are over age 50, obese, immunocompromised or have heart, lung, liver or kidney disease.

The results didn’t show a significant difference between the high dose and low dose of the treatment, so Regeneron is reviewing the dosage needed for the ongoing trial since a limited supply exists, the company said.

In September, the company released data on 275 patients that showed the treatment reduced viral levels and improved symptoms. The new data confirms those findings, the company said.

Regeneron said this month that it has 50,000 doses ready for distribution, according to Reuters. The federal government signed a contract with the company this summer to buy up to 300,000 doses for $450 million.

“We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” David Weinreich, MD, senior vice president and head of global clinical development at Regeneron, said in the statement released Wednesday.

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Sources

Regeneron, “Regeneron’s COVID-19 outpatient trial prospectively demonstrates that REGN-COV2 antibody cocktail significantly reduced virus levels and need for further medical attention.”

Regeneron, “Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients.”

Reuters, “Regeneron says its COVID-19 antibody treatment cut medical visits in trial.”

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