Eli Lilly and Co informed that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by US President Donald Trump has been paused because of a safety concern.
Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals that he received for his COVID-19, as tantamount to a cure in a video.
Lilly said earlier this month it was applying for emergency use authorisation (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.
“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrolment. Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” Lilly spokeswoman Molly McCully said in an emailed statement.
The company did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalisation, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.
Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.
The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.
Lilly sought the EUA from US regulators after publishing data in September showing LY-CoV555 helped cut hospitalisation and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.
(Edits by EP News Bureau)