Regeneron Pharmaceuticals Inc. suspended the testing of its Covid-19 antibody in the most ill-fated hospitalized patients over safety concerns, the latest step backwards for antibody drug trials in patients with the disease. heaviest.
Regeneron on Friday said it was suspending enrollment of Covid-19 hospitalized patients receiving mechanical ventilation or high-flow oxygen, after an independent monitoring committee observed “a potential safety signal and an adverse risk / benefit profile at this point. “
The committee recommends that such patients be suspended until further data are collected and analyzed.
These dynamics do not affect other trials of antibody drugs, which were demonstrated in a separate trial to reduce viral levels and visit a doctor. The drug is now approved by the Food and Drug Administration, along with a similar drug from Eli Lilly & Co.
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The Regeneron study will continue to enroll hospitalized patients who receive low or no oxygen-assisted oxygenation, who tend to be less ill than those who need heavy oxygen or assist with mechanical ventilation. The risk benefit for less severe hospitalized patients is still acceptable, the company says.
The committee also recommends that a study of the drug in non-hospitalized patients be continued without modification, the company said.
Partial research has shown that the promising monoclonal antibody layer may be inactive in hospitalized patients with the most severe cases of Covid-19. On Monday, a study of Eli Lilly monoclonal antibodies in hospitalized patients was terminated after it was determined that the drug was unlikely to provide any benefit.
|RAIN||REGENERON PHARMACEUTICALS INC.||543.56||-12,23||-2.20%|
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Shares of Regeneron fell 2.3% to $ 542.29.
Earlier this month, President Trump was treated with Regeneron antibody, after which he noted his recovery from Covid-19.