Biotechnology company Regeneron Pharmaceuticals said today that it is launching a series of clinical trials to test the safety and efficacy of an investigational antibody cocktail for the treatment and prevention of COVID-19.
According to a company press release, Regeneron, of Tarrytown, New York, will conduct placebo-controlled trials of REGN-COV2 at multiple sites in four different populations: hospitalized COVID-19 patients, non-hospitalized patients with COVID-19 symptoms, uninfected people in high-risk groups such as healthcare workers, and uninfected people in close contact with infected patients.
The first two trials will focus on virologic, safety, and clinical end points in hospitalized and non-hospitalized patients.
Similar to Ebola antibody cocktail
REGN-COV2 consists of two virus-neutralizing antibodies that bind non-competitively to the critical receptor binding domain of the spike protein that SARS-COV-2 (the virus that causes COVOD-19) uses to enter cells. The antibodies were selected from thousands of antibodies produced by mice that have been genetically engineered by the company to have a human-like immune system, and from patients who have recovered from COVID-19.
The hope is that the cocktail of antibodies, which mimic the type of antibodies the human immune system produces if exposed to SARS-CoV-2 or a vaccine, can both prevent and treat coronavirus infections. The company also says preclinical studies indicated that REGN-COV2 may reduce the potential for viral escape, which occurs when a virus mutates to evade the body's immune response.
"We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral 'escape,' a critical precaution in the midst of an ongoing global pandemic," said Regeneron president and chief scientific officer George Yancopoulos, MD, PhD. "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."
The results of the preclinical studies will be published in Science next week.
The cocktail is similar to REGN-EB3, a triple-antibody drug developed by Regeneron for treating Ebola. The Food and Drug Administration granted priority review for REGN-EB3 in April after trials conducted in Ebola treatment centers in the Democratic Republic of the Congo found the drug was one of two that proved more effective than other options.
Regeneron received funding from the Biomedical Advanced Research and Development Authority to develop REGN-COV2.
Evaluating COVID-19 treatments in kids
In other COVID-19 drug research news, the National Institutes of Health (NIH) yesterday said researchers will begin evaluating in infants, children, and adolescents antiviral and anti-inflammatory drugs currently being used to treat COVID-19.
The study, which is part of a larger clinical trial evaluating the pharmacokinetics of understudied drugs administered to children, will analyze blood samples to better understand how drugs used to treat COVID-19 move through the bodies of children, and to collect information on outcomes and potential side effects. Many of the drugs have not been tested specifically for use in children.
"As we search for safe and effective therapies for COVID-19, we want to make sure that we do not overlook the needs of our youngest patients who may respond differently to these drugs, compared to adults," Diana Bianchi, MD, director of NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which oversees the project, said in a news release.
The NIH says the aim of the study is to gather information to refine dosing and improve safety, and not to evaluate the best treatment.