An antibody cocktail is now beginning late-stage clinical trials to assess the drug’s ability to prevent and treat coronavirus infection.
© Regeneron
New York State biotechnology company Regeneron is working on antibody therapy to treat and possibly prevent Covid-19.
Biotech company Regeneron announced late-stage clinical trials of REGN-COV2, its investigational dual-antibody cocktail for the treatment and prevention of Covid-19, in a press release on Monday.
Specifically, the statement noted that a Phase 3 trial of the drug will assess its ability to prevent coronavirus infection among uninfected people who have had close contact with an infected person, such as a patient’s housemate. According to Regeneron, the phase 3 prevention trial is being conducted at around 100 sites and is expected to include 2,000 patients across the United States.
According to Regeneron, the drug also went into the Phase 2/3 part of two trials that test its ability to treat inpatients and outpatients with Covid-19. These trials will involve 1,850 inpatients and 1,050 outpatients, and are expected to be conducted at 150 sites in the United States, Brazil, Mexico, and Chile.
“We are conducting simultaneous 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 an ongoing global pandemic,” said Dr. George D. Yancopoulos, co-founder, Regeneron president and chief scientific officer, said in the company’s press release.
© Regeneron
New York State biotechnology company Regeneron is working on antibody therapy to treat and possibly prevent Covid-19.
The statement also noted that the trial is being run in conjunction with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Antibodies are proteins that the body produces naturally to protect it from a threat like Covid-19. To make what’s called monoclonal antibodies for an antibody cocktail, scientists analyze thousands of antibodies to find out which ones fight the new coronavirus most effectively.
In this case, the Regeneron scientists took two antibodies, expanded them, and put them into a drug that they hope can be used to treat symptoms and possibly even work as protection for vulnerable communities like the elderly or healthcare workers.
Going into these late-stage trials means the drug has already shown positive results in previous human trials evaluating 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 who are hospitalized with Covid-19; people who have symptoms of the disease but are not hospitalized; healthy people but at high risk of getting sick; and healthy people who have had 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 treatment on humans on June 1. There are a handful of other companies working on additional antibody therapies.
© Regeneron
New York State biotechnology company Regeneron is working on antibody therapy to treat and possibly prevent Covid-19.
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