U.S. drugmaker Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.
Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as virtual “cures” in a video he posted last week.
The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.
Lilly said earlier this month it was applying for emergency use authorization for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.
The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on patients who require hospitalization, or on its other ongoing trials. It is also testing the drug on volunteers in nursing homes to see if it prevents them from getting sick.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
Lilly sought the EUA from U.S. regulators after publishing data in September showing it helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.
Lilly shares were down nearly 3%.
