Amid new worries about COVID-19 vaccine supplies, monoclonal antibodies—such as those from Eli Lilly and Regeneron—could be important stopgaps to reduce deaths and hospitalizations until vaccinations gain steam. And Lilly is touting data showing two of its antibodies did just that in high-risk patients.
In a phase 3 study of more than 1,000 high-risk patients recently diagnosed with COVID-19, 11 patients who received a bamlanivimab-etesevimab combo were hospitalized and none died. That compared with 26 hospitalizations and 10 deaths among placebo patients, which translates into a 70% reduction in the risk of a COVID-19 hospitalization or death.
Aside from the trial’s primary endpoint of reducing those two outcomes, the antibody duo met secondary endpoints such as evidence of reduced viral load and improved resolution of symptoms.
The trial data “add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic,” Lilly Chief Scientific Officer Dan Skovronsky, M.D., Ph.D., said in a statement.
"The death toll from COVID-19 continues to rise around the world, and hospitalizations, particularly in the U.S., have reached record highs," he said. “These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.”
Tuesday’s results come right after Lilly posted data showing bamlanivimab cut nursing home staff and residents’ risk of developing symptomatic infections by 57% against placebo. With these data, the company could ask the FDA to authorize it as a preventive measure.
The trial showed antibodies could be another tool to prevent COVID-19 in vulnerable patients on top of vaccines, SVB Leerink analyst Geoffrey Porges wrote in a note to clients. But there are hurdles to getting the medicine to patients who need it, he noted.
Currently, bamlanivimab carries an emergency use authorization for high-risk patients with mild to moderate cases. But because the drug is infused and its target patients typically aren’t already in an infusion setting—such as a hospital—the medicine hasn't reached as many patients as originally expected.
To help, the company is asking the FDA to allow infusion times as short as 16 minutes—down from the current authorization of 60 minutes. The change could simplify administration and cut hospital burdens, Lilly notes.
Meanwhile, the company in November submitted the combination of bamlanivimab and etesevimab to the FDA as another option to reduce high-risk patients' disease progression.
The company has partnered on antibody production and expects to produce up to 1 million doses of the combination by the middle of 2021.