Eli Lilly’s investigational therapy, LY-CoV555, was shown to be well-tolerated and met its primary endpoint for one of its doses.
Eli Lilly’s investigational IgG1 monoclonal antibody (mAb) therapy, LY-CoV555, showed a reduced rate of hospitalizations for COVID-19 patients in the outpatient setting.
This comes from interim analysis of its phase 2 BLAZE-1 clinical trial for LY-CoV555. Rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo—a 72 percent risk reduction in this limited population. Most hospitalizations in the study occurred in patients with underlying risk factors (age or BMI), suggesting a more pronounced treatment effect for patients in these higher-risk groups.
"These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19."
The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients and broke them up into four groups for medication administration (placebo, 700 mg, 2800 mg, and 7000 mg).
LY-CoV555 was shown to be well-tolerated and met its primary endpoint of viral load change from baseline at day 11 for one of its doses: 2800mg.
LY-CoV555 is a neutralizing mAb directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
Lilly intends to publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with regulators.
A phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting is ongoing, and the company initiated a phase 3 study for the prevention of COVID-19 in residents and staff at long-term care facilities The investigational therapy is also being tested in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients.