Despite the recent kickback controversy, biotechnology company Regeneron announced that their Phase 3 prevention trial has begun that will be used to evaluate the drug’s ability not only to treat COVID-19, but also, prevent the virus.
Phase 3 is launched
Phase 3 trial of Regeneron will evaluate the drug’s ability to prevent COVID-19 among uninfected people who have been exposed to those who have been infected, such as a roommate or family member.
The prevention trial is happening jointly with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, across the country at 100 sites and is expected to include 2,000 patients, according to Regeneron.
“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 Dr. George D. Yancopoulos, Co-founder, President, and Chief Scientific Officer of Regeneron.
The drug has also moved into the Phase 2/3 portion of two trials testing its ability to treat hospitalized and non-hospitalized patients with COVID-19. These trials will focus on 1,850 hospitalized patients and 1,050 non-hospitalized patients, and will be conducted at 150 locations in the United States, Brazil, Mexico, and Chile.
How antibody therapy works
Antibody tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. “In other words, the test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself,” said Stephen M. Hahn M.D., Commissioner of Food and Drugs for the Food and Drug Administration (FDA).
Generally for infectious diseases, immunoglobulin M (IgM) antibodies, which are the first type of antibody produced by the immune system in response to a pathogen and stay in the bloodstream for weeks, indicate that someone was recently infected. Immunoglobulin G (IgG) antibodies stay for years and are a sign of a past infection. Serological tests generally check for both types of antibodies in a blood sample.
The accuracy of the tests have not always been guaranteed, which is the reason for the continuation of trials. Public health experts are debating whether or not the antibody tests could be a powerful tool to determine when it’s safe to reopen the country. Some experts are warning that just because a person has antibodies to the coronavirus doesn’t mean they are immune to it.
Funding and the FDA
Concerns are rising about the accuracy and availability of the tests and how it could hamper plans to allow Americans to go back to “normal life” at work and school. Experts are quick to say that there will be a new “normal” if and when Americans return to work and school.
Operation Warp Speed, the federal government’s COVID-19 vaccine program, is funding Phase 3 with a $450 million contract to manufacture and supply the antibody treatment as soon as it is FDA approved.
“This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic,” said Dr. Leonard S. Schleifer, co-founder and chief executive office of Regeneron.