Remdesivir was developed by U.S. drugmaker Gilead Sciences, and received partial approval for use in the U.S. and the European Union after a trial by the U.S. National Institutes of Health.
On Tuesday, independent monitors paused enrollment in a study testing remdesivir, plus an experimental antibody therapy being developed by Eli Lilly, that’s similar to Trump’s treatment.
Lilly confirmed Tuesday that the study had been paused “out of an abundance of caution” and said safety is its top concern. The company would not say more about what led to this step.
The U.S. National Institute of Allergy and Infectious Diseases, which sponsors the study, did not comment.
This study was testing a single antibody that Lilly is developing with the Canadian company AbCellera. Trump received an experimental two-antibody combo drug from Regeneron Pharmaceuticals Inc.
Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while late-stage studies continue.
The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isn’t disclosing the nature of the illness.
“It may have nothing to do with the vaccine,” said Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business.
Mammen said the company doesn’t know yet whether the ill participant received the experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.
The study of the one-dose vaccine will include up to 60,000 people from multiple countries. The company expects to complete enrollment in the study in two or three months.
Coronavirus cases around the world have climbed to all-time highs of more than 330,000 per day as the virus has seemingly come storming back across Europe and renewed speed in the U.S., forcing many places to reimpose tough restrictions they had eased just a few months ago.