Eli Lilly Terminates ACTIV-3 Trial of Bamlanivimab Due to Lack of Efficacy in Hospitalized COVID-19 Patients

On October 26, Eli Lilly issued a statement announcing the termination of the ACTIV-3 clinical study of the COVID-19 neutralizing antibody bamlanivimab (LY-CoV555), citing that the treatment was unlikely to help hospitalized COVID-19 patients recover from the late stages of the disease.

Two weeks ago, the independent Data Safety Monitoring Board (DSMB) recommended suspending Eli Lilly’s ACTIV-3 trial due to potential safety concerns. However, on Monday, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) which sponsors Eli Lilly’s research, halted the trial—not due to any safety issues, but because the drug demonstrated minimal efficacy.

Eli Lilly stated that although the ACTIV-3 clinical study faced setbacks, other studies by Eli Lilly are still ongoing. These ongoing studies focus on patients with mild to moderate COVID-19 to prevent hospitalization and disease progression.

Both Eli Lilly and Regeneron have applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization, while late-stage studies are still ongoing. According to the Associated Press, Eli Lilly stated on Monday that its application was based on findings from other studies indicating that the drug could help non-hospitalized patients, and that the company would continue to seek FDA emergency use authorization.

References:

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness.

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