Eli Lilly Pauses Trial of Combination Antibody Treatment for COVID-19 Due to Safety Concerns

An ongoing clinical trial evaluating the efficacy of Eli Lilly and Company’s (Indianapolis, Ind, USA) neutralizing antibody in hospitalized COVID-19 patients has been paused due to safety concerns.

The decision was taken after recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause enrollment of the study which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results.

Lilly has been collaborating with the US government and industry partners to discover potential treatments, including learning about the potential impact of neutralizing antibodies across the broadest set of patients. The ACTIV-3 clinical trial is evaluating Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) in combination with Gilead Sciences’ antiviral (Foster City, CA, USA) remdesivir as a treatment for COVID-19 in hospitalized patients.

The ACTIV-3 clinical trial is the only ongoing study evaluating the efficacy of Lilly’s neutralizing antibody in hospitalized COVID-19 patients, the most advanced stage of the disease. The dose of bamlanivimab being investigated in this trial is 7000 mg. According to Lilly, individuals in the ACTIV-3 study have been infected with the virus for a longer period of time and may have more severe symptoms than patients studied in other bamlanivimab trials.

Lilly is testing both single antibody therapy, as well as combinations of antibodies as potential therapeutics for COVID-19, across two different patient populations. For instance, bamlanivimab is also being tested in the NIH-led ACTIV-2 study in recently diagnosed mild to moderate COVID-19 patients. These trials are not affected by the enrollment pause in the NIH-sponsored trial of hospitalized patients. The DSMB has considered the impact of the ACTIV-3 study pause on ACTIV-2 and has not recommended any changes to that study’s design or enrollment.

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