By Kathleen Berger Executive Producer for Science & Technology
Update: The Food and Drug Administration (FDA) grants emergency use authorization for Regeneron’s antibody therapy, now the second COVID-19 antibody treatment winning emergency use approval.
When President Donald Trump was infected with COVID-19, he was given the Regeneron monoclonal antibody therapy as part of his treatment regimen. At the time, the antibody treatment was experimental before emergency use authorization was granted.
Washington University School of Medicine in St. Louis is involved in varied clinical trials using two different monoclonal antibody therapies: the one given to President Trump from Regeneron Pharmaceuticals and the Eli Lilly treatment. The Eli Lilly antibody treatment was first to win emergency use approval from the FDA.
Monoclonal antibodies are made in a lab to mimic the body’s natural antibodies, harnessing the immune system to fight off COVID-19
Rachel Presti, MD, PhD, oversees clinical trials as Medical Director of the Infectious Diseases Clinical Research Unit at Washington University School of Medicine in St. Louis.
“They’ve figured out a way to grow up an individual B-cell that makes a single antibody,” said Presti. “So it’s a clone, and everything about it is identical. And then they can take those individual antibodies and they can figure out which one is the best antibody to bind or to target an immune response, and so on, against a given germ.”
Dr. Presti is principal investigator of the clinical trial for the Eli Lilly monoclonal antibody therapy. In her study, the infusion is given to COVID-19 outpatients.
Presti said providing Eli Lilly infusions is considered clinical care as it moves into a phase 3 clinical trial. That’s because the FDA granted emergency use authorization for the Eli Lilly IV treatment.
Emergency use is meant for adults and children over age 12 experiencing mild to moderate illness and are high risk for getting worse, needing hospitalization.
Dr. Presti says preliminary studies of the Eli Lilly monoclonal antibody treatment show no benefit for hospitalized patients with severe cases. However, Washington University is conducting a clinical trial with Regeneron’s monoclonal antibody cocktail for hospitalized patients.
The Regeneron treatment combines two antibodies — casirivimab and imdevimab — and administers them together by IV. In a clinical trial of about 800 people, the combination was shown to significantly reduce virus levels within days of treatment. The antibody cocktail is the first combination therapy to receive emergency use authorization.
In another Regeneron clinical trial at Washington University, investigators hope to discover if an injection of Regeneron would help household members of COVID-19 positive patients.
“We are looking to see, if household contacts, if given an injection prevents them from actually getting COVID-19, and if they do get it, if it prevents them from getting very sick with it,” she said.
Presti explained enrollment with household members is more difficult because the window is very short. But she said the research is advancing and they are successfully enrolling people in the St. Louis region for clinical trials in the fight against COVID-19.