INDIANAPOLIS — Pharmaceutical giant Eli Lilly’s late-stage clinical trial of its leading antibody treatment for the novel coronavirus was paused Tuesday by U.S. health officials due to a “potential safety concern.”
The concerns, flagged in emails government officials sent to researchers at testing sites, were confirmed by the company, The New York Times reported.
“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,” spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
The news comes one day after Johnson & Johnson paused its late-stage clinical trial for a potential COVID-19 vaccine, dubbed ENSEMBLE, citing an unexplained illness in a study volunteer.
Meanwhile, medical experts contend that pauses in large clinical trials when ailments in participants occur are quite routine, in order to determine if the afflictions are side effects of the vaccines being tested or purely coincidental, CNN reported.
Dr. Mathai Mammen, global chief of J&J’s Janssen research and development arm, told investors during a Tuesday conference call that the company still has few details regarding the vaccine trial’s pause, including whether the patient who fell ill received the experimental vaccine or the placebo, CNBC reported.
Lilly’s ACTIV-3 trial is intended to test a monoclonal antibody developed in partnership with Gilead Sciences' remdesivir, an antiviral drug granted emergency use authorization by the U.S. Food and Drug Administration to treat COVID-19 infections, the outlet reported.
Emails sent Tuesday instructed Lilly researchers to halt enrollment in the trial, which is sponsored by several National Institutes of Health branches and the U.S. Department of Veterans Affairs, out of an “abundance of caution,” the Times reported.
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