Eli Lilly COVID-19 antibody trial paused due to safety concerns
El Lilly & Co. paused enrollment of participants in a clinical trial of its antibody treatment for COVID-19 due to a potential safety concern, pushing down the company’s shares.
An independent data safety monitoring board recommended pausing enrollment in the U.S. government-sponsored trial, a company spokeswoman said in an emailed statement. The company didn’t provide any information about what caused the data panel to recommend the pause.
Lilly is one of several companies developing antibody therapies, including Regeneron Pharmaceuticals Inc. Both Lilly and Regeneron have are now seeking emergency authorization of the treatments. Regeneron’s therapy was given to President Donald Trump when he was infected with COVID-19. He has since called that therapy a “cure,” and said he would push for it and other similar treatments to get approval in the U.S.
Lilly, meanwhile, said it is supportive of a decision by the independent monitoring board to “cautiously ensure the safety of the patients participating in this study,” according to spokeswoman Kathryn Beiser.
Shares of Eli Lilly declined as much as 3.8% in afternoon trading on Tuesday in New York. The announcement follows by a day Johnson & Johnson’s decision to pause its vaccine trial because of a sick volunteer.
Such pauses for large clinical trials can occur, and don’t necessarily mean anything is wrong with the treatment. A final decision must be made by the monitoring board before any future action is taken. Preliminary data from both Lilly and Regeneron have been largely positive, suggesting their drugs have the ability to lower the amount of virus in the body.
The National Institutes of Health is testing Lilly’s experimental monoclonal antibody in ambulatory and hospitalized Covid-19 patients. The trial is known as ACTIV-3, and preliminary data isn’t yet available. Lilly is developing its antibody with Canadian biotech AbCellera Biologics Inc.
News of the trial pause was first reported by the New York Times.