A government-sponsored clinical trial testing a coronavirus antibody treatment from Eli Lilly has stopped enrolling volunteers over safety concerns — days after the company asked the FDA to approve emergency use of the treatment.
“Lilly is supportive of the decision by the independent [data safety monitoring board] to cautiously ensure the safety of the patients participating in this study,” a company spokesperson said Tuesday.
Neither Lilly nor the National Institute of Allergy and Infectious Diseases, which is sponsoring the trial, have described the safety issue that prompted the decision to pause the study. NIAID has not yet responded to a request for comment.
The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.
Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.
That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.
What’s next: The data and safety monitoring board overseeing the trial will try to better understand what caused the safety concern and whether or not to restart the trial.
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