Regeneron Pharmaceuticals Inc. suspended testing of its Covid-19 antibody drug in the sickest hospitalized patients because of a safety concern, the latest setback for antibody-drug trials in patients with the most advanced disease.
Regeneron said Friday it is pausing enrollment of hospitalized Covid-19 patients receiving mechanical ventilation or high-flow oxygen, after an independent monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at this time.”
The committee recommended pausing enrollment of those patients until further data is collected and analyzed.
The moves don’t affect other testing of the antibody drug, which proved in a separate trial to reduce virus levels and doctor visits. The drug is now up for authorization by the Food and Drug Administration, along with a similar drug from Eli Lilly & Co.
The Regeneron study will continue enrolling hospitalized patients receiving low amounts of oxygen or no oxygen support, who tend to be less sick than those who require heavy oxygen or mechanical breathing assistance. The company said the risk-benefit for the less serious hospitalized patients remains acceptable.