Regeneron Pharmaceuticals Inc. said Friday that independent observers had recommended that the most critically ill patients – those who require intensive oxygen treatment or breathing apparatus – be put on hold because of a potential safety issue and an adverse balance of risks and benefits.
The study can continue to test the combination of two antibodies in hospital patients who need little or no supplemental oxygen, the monitors said. Other studies in light or moderate people will also continue.
Antibodies are proteins that the body produces when infected. They attach themselves to a virus and help get rid of it. However, it can take several weeks for the most effective to form.
The experimental drugs are said to help immediately by delivering concentrated versions of one or two antibodies that work best against the coronavirus in laboratory and animal studies.
Earlier this month, another group of monitors recommended suspending enrollment in a US National Institutes of Health study testing an Eli Lilly antibody drug to investigate a possible safety issue in hospitalized patients.
On Monday, the NIH announced that no safety issue had been verified, but the study was canceled because the drug did not appear to work in the situation.
“These types of results tell us when to use them,” said Dr. Myron Cohen, a University of North Carolina virologist who advises the government on COVID-19 treatments.
Animal studies suggest that antibody drugs work best when given early in infection to lower the amount of virus, he said. Once someone is very sick, the medication may not help, but it is too early to know if it is, he said.
Doctors already know timing can play a role in COVID-19 treatments. Studies suggest that dexamethasone and other steroids may lower the risk of death when given to very sick patients to suppress an overactive immune system. However, they can be harmful to the mildly ill.
Lilly and Regeneron have asked the Food and Drug Administration to approve the use of their experimental antibody drugs for light and moderate patients who do not require hospitalization in an emergency.
Regeneron said it would share advice from independent observers on Friday with the FDA and the heads of a separate study in the UK testing the drug in hospital patients.
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