Use Regeneron’s antibody drug-trial handed over to Trump to treat severe COVID-19 patients suspended due to potential safety hazards
- The company said on Friday that external monitors have advised Regeneron to suspend testing of coronavirus antibody drugs in hospitalized patients.
- Regeneron cited “potential security risks” but did not provide any details
- Its trial of the antibody mixture-handed over to President Trump-for the treatment of milder patients can continue
- Competitor Eli Lilly had to suspend antibody treatment trials for severe COVID-19 patients earlier this month
On Friday, Regeneron’s highly anticipated coronavirus antibody drug faced a setback when an external expert panel recommended that the antibody mixture be suspended for “severe safety risks” to treat patients with severe COVID-19.
The antibody mixture trial-the same experimental treatment given by President Trump shortly after testing positive for COVID-19 earlier this month-could continue to treat coronavirus patients with mild illness.
This is the second antibody drug trial that has been suspended for several weeks. On October 13, Eli Lilly’s trial of its antibody therapy combined with remxidivir for inpatient treatment was also suspended.
The regulator said that it expects a suspension of the trial and even characterizes it as an encouraging sign that the drug testing process and vaccine are running because it should raise safety issues before approval.
Nonetheless, this is a blow to President Trump. Since the US Food and Drug Administration (FDA)’s request to authorize the use of the coronavirus vaccine changed his hopes of having a vaccine before November 3, President Trump has been Therapies approved before election day are urged.
The company said on Friday that due to “potential safety hazards”, Regeneron has suspended trials of the coronavirus antibody drug (pictured) used by Regeneron to treat hospitalized COVID-19 patients (document)
Regeneron said on Friday that due to potential safety issues and an unfavorable balance between risks and benefits, the independent guardian recommended that the recruitment of critically ill patients-critically ill patients be suspended.
Neither the company nor its security monitors provided any details about the nature of the “security issue”.
Monitors said the study could continue to test the drug combination of the two antibodies in hospitalized patients who need little or no additional oxygen. Other studies in mild or moderate populations are also continuing.
Antibodies are proteins produced by the body during infection. They will attach to the virus and help eliminate it.
However, the most effective process may take several weeks. These experimental drugs are designed to help immediately by providing one or two concentrated forms of antibodies that are most effective against coronavirus in laboratory and animal tests.
Earlier this month, another group of monitors recommended the suspension of a study by the National Institutes of Health (NIH) that tested Eli Lilly antibody drugs to investigate possible safety issues in hospitalized patients.
The National Institutes of Health said on Monday that it had not confirmed the safety issue, but because the drug appeared to be ineffective in this case, they stopped the study.
Dr. Myron Cohen, a virologist at the University of North Carolina, said: “These results let us know when to benefit.” He advises the government on COVID-19 treatment.
He said that tests on animals have shown that antibody drugs are best given in the early stages of infection to reduce the number of viruses. He said that once someone is seriously ill, drugs may not help, but now it is too early to know if it is too early.
Doctors already know that for COVID-19 treatment, timing is important.
Studies have shown that when dexamethasone and other steroids are used in critically ill patients to reduce the overactive immune system, they can reduce the risk of death, but they may be harmful to those with mild illness.
Lilly and Regeneron have requested the U.S. Food and Drug Administration (FDA) to allow the emergency use of experimental antibody drugs for mild and moderate patients in urgent need of treatment.
Regeneron said it will share Friday’s recommendations with the leaders of the U.S. Food and Drug Administration (FDA) and another study in the UK on drug testing in hospitalized patients.