Regeneron’s antibody cocktail has entered Phase 3 clinical trials to evaluate the drug’s efficacy in the prevention and treatment of coronavirus infection.

Biopharmaceutical giant Regeneron announced the start of the REGN-COV2 Phase 3 COVID-19 prevention trial on Monday, July 6. The trial will be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).

On Tuesday, the company announced that it has received $450 million contract to manufacture and supply the antibody treatment in the U.S. This contract is a part of President Donald Trump’s “ Operation Warp Speed ” COVID-19 vaccine program.

The contract will allow the COVID-19 cocktail drug to be available in the U.S. for prevention and treatment as soon as the clinical trials are deemed successful and the Food and Drug Administration (FDA) gives approval or emergency use authorization for its use.

REGN-COV2 is an investigational double-antibody cocktail that has been prepared for the prevention and treatment of COVID-19. The last-stage Phase 3 study will evaluate the efficacy of the cocktail in preventing coronavirus infection in healthy individuals who have had close exposure to a patient with COVID-19.

In another trial, the same drug cocktail is also being tested for the ability to treat hospitalized patients with COVID-19 infection alongside those with COVID-19 positive status but recovering at home (non-hospitalized).

The Phase 3 trial is expected to enroll 2000 patients from different locations within the U.S. The study will be conducted across 100 sites in the country.

"We are running simultaneous adaptive trials in order 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," said George D. Yancopoulos, Co-Founder, President and Chief Scientific Officer of Regeneron, in an official statement.

Regeneron scientists based REGN-COV2 on a combination of two antibodies after studying thousands of human antibodies produces in mice as well as those retrieved from patients who recovered from COVID-19. The two most potent, non-competing and virus-neutralizing antibodies were selected to produce the cocktail.

These two antibodies work by binding to the critical receptor that binds to the spike protein of coronavirus. This, in turn, mitigates the chances of coronavirus escaping treatment and also prevents the mutant version of the coronavirus from attacking the cells.

Vaccine
Discussion about the Cuba's life-saving lung cancer vaccine called CimaVax-EGF is growing rapidly. REUTERS/Eric Gaillard

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