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Regeneron starts Phase 3 trial of Covid-19 antibody cocktail

Biotechnology company Regeneron announced late-stage clinical trials of REGN-COV2, its experimental double-antibody cocktail for the treatment and prevention of Covid-19, in a press release Monday.

In particular, the release noted that a phase 3 study of the drug will evaluate its ability to prevent coronavirus infection among uninfected people who have had close contact with an infected person, such as a patient’s roommate. The Phase 3 prevention study is taking place at around 100 sites and is expected to include 2000 patients in the United States, according to Regeneron.

The drug also moved to the Phase 2/3 part of two studies that tested its ability to treat hospitalized and non-hospitalized patients with Covid-1

9, according to Regeneron. These studies will involve 1,850 hospitalized patients and 1,050 non-hospitalized patients and are expected to be conducted at 150 sites in the United States, Brazil, Mexico and Chile.

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

The release also noted that the trial was conducted jointly with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

A coronavirus vaccine is still months away, but an antibody treatment may be closer

Antibodies are proteins that the body naturally produces to protect the body from a threat like Covid-19. To create what are called monoclonal antibodies for a cocktail of antibodies, scientists examine thousands of antibodies to understand which ones fight the new coronavirus more effectively.

In this case, Regeneron scientists collected two antibodies, scaled them down and turned them into a drug that he hopes can be used to treat symptoms and possibly even work as a protection for vulnerable communities such as the elderly or healthcare professionals.

Entering these advanced studies means that the drug has already shown positive results in previous human studies that evaluated safety, which started in June. Phase 1 safety outcomes included an initial cohort of 30 hospitalized and non-hospitalized patients with Covid-19, according to Regeneron.
Regeneron said last month that his antibody cocktail will be tested in four separate study populations: people hospitalized with Covid-19; people who have symptoms of the disease but are not hospitalized; people who are healthy but are at high risk of getting sick; and healthy people who came in close contact with a sick person.

Regeneron is not the first company to undergo human Covid-19 antibody therapy. Eli Lilly and AbCellera started testing their antibody treatment in humans on June 1st. There are some other companies working on further antibody therapies.

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