The independent monitoring committee for Regeneron Pharmaceuticals trials of REGN-COV2, its promising antibody cocktail drug for COVID-19, has recommended placing a hold on further trial enrollment of hospitalized patients who require high-flow oxygen or mechanical ventilation.
The recommendation is based on a “potential safety signal and an unfavorable risk/benefit profile at this time,” according to a statement on Regeneron’s website.
The committee recommended continuing enrollment of hospitalized patients “requiring either no or low-flow oxygen as the risk/benefit remains acceptable” and “continuance of the outpatient trial without modification.”
The drug, along with the steroid dexamethasone, the repurposed Ebola drug remdesivir and supplemental oxygen, were given to President Donald Trump when he was hospitalized for COVID-19 in early October at Walter Reed National Military Medical Center.
It consists of two cloned antibodies designed to neutralize SARS-CoV-2, the virus that causes the respiratory disease, by blocking its ability to infect the body through binding with host cells.
The drug was said to show promise this summer in helping to reduce the viral load as well as alleviate symptoms in trials involving non-hospitalized patients being treated for COVID-19, and specifically in those patients who had not mounted their own immune response to SARS-COV-2.
Antivirals are generally considered to work better when given before an infection has taken hold in the body.
Regeneron said it is informing the U.S. Food and Drug Administration, which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes.
It said it would share the recommendation with the independent committee monitoring the RECOVERY trial in the UK, which is evaluating REGN-COV2 in hospitalized patients.
Eli Lilly & Co. recently announced the clinical trial involving the use of its antibody drug bamlanivimab as an added treatment in hospitalized COVID-19 patients had ended as the trial showed it “is unlikely to help” these patients “recover from this advanced stage of their disease.”
It said other trials involving the drug would continue.
