The New York Times reported that Eli Lilly’s testing site researchers were notified of the pause by emails sent by government officials (it is a government-sponsored trial) and the company later confirmed it. A spokesperson from the company told The Hill that “Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment.”
Eli Lilly’s trial was comparing its therapy to a placebo, while all study participants also received the experimental drug remdesivir, which has been used in treating COVID-19 throughout the pandemic. The company’s therapeutic uses monoclonal antibodies in an effort to block the virus from infecting cells.
Preliminary data from Eli Lilly and Regeneron, which developed a similar treatment recently put in the spotlight after it was given to President Donald Trump during his bout with the virus, shows that the drugs could reduce symptoms by lowering the amount of the virus in an infected person’s body, according to The New York Times.
News of Eli Lilly’s trial pause follows the announcement that Johnson & Johnson (NYSE:JNJ) temporarily paused further dosing in its COVID-19 vaccine candidate clinical trials. The pause in the trials conducted by J&J’s Janssen Pharmaceuticals subsidiary follows an unexplained illness arising in a study participant, according to a news release. Under the company’s guidelines, the illness is being reviewed and evaluated by internal and independent investigators.
Johnson & Johnson’s trial pause was marked the second high-profile COVID-19 vaccine candidate study to be put on hold after AstraZeneca last month stopped its trial to conduct a review after an unexplained patient illness.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease