For the second time, a study of an experimental antibody drug to treat Covid-19 was put on hold to investigate a possible safety problem in hospitalized patients, the pharmacist in charge of the study said on Friday.
Regeneron Pharmaceuticals Inc. said independent observers had recommended suspending the enrollment process for critically ill patients, those who need heavy oxygen treatment or be hooked up to respirators, due to a potential safety issue and an unfavorable balance of risks and risks. Benefits.
The study may continue to test the two-antibody drug in hospitalized patients who need little or no oxygen, the observers said. Other studies in people with mild or moderate symptoms will also follow.
Antibodies are proteins that the body makes when an infection occurs; they attach themselves to the virus and help to eliminate it. But it may take several weeks for the most effective ones to form. The experimental drugs are intended to help immediately by administering concentrated versions of one or two specific antibodies that performed best against the coronavirus in laboratory and animal tests.
A few weeks ago, a different group of observers recommended suspending enrollment in a National Institutes of Health (NIH) study examining an antibody drug developed by Eli Lilly to investigate a possible safety problem in patients. hospitalized. On Monday, the NIH said no problem had been verified, but paused the study because the drug did not seem to work in that situation.
“These types of results inform us about the moment of benefit,” said Dr. Myron Cohen, a virologist at the University of North Carolina who advises the government on treatments for Covid-19.
Animal tests showed that antibody drugs work best when given early in the illness to reduce the amount of the virus, Cohen said. Once someone is seriously ill, medications may not help, but it is still too early to tell if they are, he added.