Eli Lilly statement on the NIAID decision to pause enrollment in ACTIV-3 clinical trial of bamlanivimab as a treatment for COVID-19 in hospitalized patients.

Eli Lilly has continued to be in communication with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause enrollment of the study. ACTIV-3, which is evaluating Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients, 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 trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study. Importantly, the DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study’s design or enrollment.