Regeneron launches Covid-19 antibody cocktail phase 3 trial


Biotechnology company Regeneron announced on Monday the latest clinical trials of REGN-COV2, its experimental dual antibody cocktail for the treatment and prevention of Covid-19.

Specifically, the release noted that a phase 3 trial of the drug will assess its ability to prevent coronavirus infection in uninfected people who have been in close contact with an infected person, such as a patient’s roommate. The phase 3 prevention trial is taking place at a hundred sites and is expected to include 2,000 patients across the United States, according to Regeneron.

The drug also entered phase 2/3 of two trials testing its ability to treat hospitalized and non-hospitalized patients with Covid-19, according to Regeneron. These trials will involve 1,850 inpatients and 1,050 outpatients, and are slated to be conducted at 150 sites in the United States, Brazil, Mexico and Chile.

“We are conducting concurrent adaptive trials to move forward as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of a global pandemic,” said co-founder Dr. George D. Yancopoulos. , president and chief scientific officer of Regeneron, said in the company’s press release.

The statement also noted that the trial is being conducted jointly with the National Institute of Allergies and Infectious Diseases, which is part of the National Institutes of Health.

Antibodies are proteins that the body naturally produces to protect the body from a threat like Covid-19. To make so-called monoclonal antibodies for an antibody cocktail, scientists comb through thousands of antibodies to determine which ones fight the new coronavirus most effectively.

In this case, the Regeneron scientists chose two antibodies, scaled them up, and put them into a drug that he hopes can be used to treat the symptoms and possibly even serve as protection. for vulnerable communities such as the elderly or health care workers.

Entry into these advanced trials means that the drug has already shown positive results in previous safety-related human trials, which began in June. According to Regeneron, the Phase 1 safety results included an initial cohort of 30 hospitalized and non-hospitalized patients with Covid-19.

Regeneron said last month that its antibody cocktail will be tested in four separate study populations: people hospitalized with Covid-19; people who show symptoms of the disease but are not hospitalized; healthy people but at high risk of getting sick; and healthy people who have come into close contact with a sick person.

Regeneron is not the first company to obtain Covid-19 antibody therapy in human trials. Eli Lilly and AbCellera began testing their antibody therapy in humans on June 1. A handful of other companies are working on additional antibody therapies.

CNN’s Jen Christensen contributed to this report.


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