Trial of Covid-19 Antibody Drug Regeneron Is Halted in Sickest Hospital Patients
31 October 2020 - 2:48AM
Dow Jones News
By Joseph Walker
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.
The committee also recommended that a study of the drug in
patients who aren't hospitalized be continued without modification,
the company said.
The partial study hold indicates that the promising class of
monoclonal antibodies might not work in hospitalized patients with
the most severe cases of Covid-19. On Monday, a study of Eli
Lilly's monoclonal antibody in hospitalized patients was terminated
after it was determined the drug was unlikely to provide a
benefit.
Regeneron shares fell 2.3% to $542.29.
Earlier this month, President Trump received treatment with
Regeneron's antibody drug, to which he later credited his recovery
from Covid-19.
(END) Dow Jones Newswires
October 30, 2020 11:33 ET (15:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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