In a statement, Eli Lilly and Company said it supports the decision of an independent data safety monitoring board to pause enrollment in a study evaluating Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients.
The study, known as ACTIV-3, 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,” Lilly said in a statement.
Lilly said the ACTIV-3 clinical trial is the only ongoing study evaluating the efficacy of Lilly’s neutralizing antibody in hospitalized COVID-19 patients and that the dose of bamlanivimab being investigated in the trial is 7000 mg.
“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. Hospitalized patients receive different treatments for COVID-19 than earlier stage patients, including treatment with the antiviral medicine remdesivir,” Lilly said.
The ACTIV-3 trial is the second COVID-19-related study paused recently. Johnson & Johnson also has temporarily paused further dosing in all of its trials evaluating its COVID-19 vaccine candidate, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant, according to a press release from the company.
