Regeneron begins first human clinical trials of COVID-19 antibody ‘cocktail’

Regeneron this morning announced starting the first human clinical trial of a so-called “cocktail” of antibodies to fight COVID-19. The drug combination uses the same approach that was successful for the company in dealing with the Ebola virus.

“REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick ”“ and could be available much sooner than a vaccine,” said George D. Yancopoulos, co-founder, president and chief scientific officer of Regeneron.

“The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.”

Four separate populations will be studied during the clinical trial. They are: hospitalized COVID-19 patients; nonhospitalized COVID-19 patients who show symptoms of the virus; uninfected people in groups that are at high-risk of exposure such as health care workers or first responders; and uninfected people with close exposure to a COVID-19 patient such as the patient’s spouse.

Some people will receive the cocktail being tested while others receive a placebo. The trials will be conducted at multiple sites. Regeneron did not identify the sites.

The cocktail consists of two antibodies that are produced in mice that have been genetically modified to have a human immune system. The antibodies being tested to fight COVID-19 are the same as if they had been produced in a human. The two antibodies bind to a protein that the virus uses to attack human cells and block it.

When faced with a harmful pathogen, such as a virus or bacteria, the human immune system typically produces antibodies to fight the invader. Specifically, the immune system produces antibodies that recognize, bind and kill or neutralize the invader.

Trial investigator, Dr. Suraj Saggar, chief of infectious disease at Holy Name Medical Center in Teaneck, New Jersey, said, “Over the last long months, we have learned that repurposing existing medicines unfortunately does not offer a broadly effective solution for COVID-19. For this reason, we need to investigate custom-designed approaches like REGN-COV2. The first studies will evaluate if REGN-COV2 can improve disease outcomes in both hospitalized and nonhospitalized patients with COVID-19.”