Lilly Statement on the NIAID Decision to Pause Enrollment in ACTIV-3 Clinical Trial
+ ACTIV-3 is an independent, NIH-sponsored study in hospitalized patients testing bamlanivimab (LYCoV555) in combination with remdesivir
+ Independent data safety monitoring board (DSMB) recommended pause
+ Pause impacts the ACTIV-3 study of a Lilly neutralizing antibody; all other studies continue
+ Lilly?s other ongoing studies focus on earlier stages of COVID-19 disease or prophylaxis
Since the beginning of the COVID-19 pandemic, Lilly has brought the full force of our?scientific capabilities to fight this new disease, collaborating with the U.S. government and industry partners to discover potential treatments. Together, we have sought to learn about the potential impact of neutralizing antibodies across the broadest set of patients even as we were still evolving in our understanding of SARS-CoV-2 virus pathology. As always, we have remained deeply committed to patient safety.
What We Know Now
As of last evening, Lilly 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.What Differentiates ACTIV-3 from Other Bamlanivimab Studies
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. 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. For these reasons, hospitalized patients may have less benefit from neutralizing antibodies, which are a supplement to the patients? own immune system, as they may have developed their own endogenous antibody response and be in a phase of disease characterized by inflammatory responses to virus. This is why the use of immunosuppressive treatments is both widespread and still being investigated in hospitalized patients.Lilly?s Neutralizing Antibody Development Program
Lilly is testing both single antibody therapy, as well as combinations of antibodies as potential therapeutics for COVID-19, across two different patient populations. Lilly?s development program includes:- BLAZE-1, an ongoing Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting?(NCT04427501). This trial is testing both bamlanivimab alone and in combination with a second antibody (etesevimab, LY-CoV016)
- BLAZE-2, a Phase 3 study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities?(NCT04497987)
- Bamlanivimab is also being tested in the NIH-led ACTIV-2 study in recently diagnosed mild to moderate COVID-19 patients.