Lilly Reports Positive Interim Results from BLAZE-1 Trial of Neutralizing Antibody LY-CoV555, Demonstrating Reduced Hospitalization Risk in Outpatients with COVID-19

Today, Eli Lilly and Company announced proof-of-concept data from the interim analysis of the BLAZE-1 clinical trial for LY-CoV555, a neutralizing antibody against the novel coronavirus jointly developed with AbCellera. This randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluated the efficacy and safety of LY-CoV555 in the outpatient treatment of symptomatic COVID-19 patients. The data indicated that treatment with LY-CoV555 was associated with a reduced hospitalization rate among patients.

LY-CoV555 is a potent IgG1 neutralizing monoclonal antibody targeting the spike protein of SARS-CoV-2. It prevents viral attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19. LY-CoV555 was identified and developed from blood samples of some of the first COVID-19 survivors in the United States.

In the BLAZE-1 clinical trial, patients with recently diagnosed mild-to-moderate COVID-19 were divided into four groups to receive either placebo or different doses of the LY-CoV555 antibody (700 mg, 2,800 mg, and 7,000 mg, respectively).

The prespecified primary endpoint of the trial was the change in viral load from baseline on Day 11 of treatment. Interim analysis results showed that the 2800 mg group met this primary endpoint, whereas the other dose groups did not. Notably, by Day 11, viral clearance was nearly complete in most patients, including those receiving placebo. Further analysis of viral data demonstrated that LY-CoV555 improved the extent of viral clearance at an earlier time point (Day 3) and reduced the proportion of patients with persistently high viral loads at subsequent time points.

These biomarker data were associated with the prespecified endpoints of COVID-19-related hospitalization or emergency department visits. Pooled across all dose groups, 1.7% (5/302) of patients treated with LY-CoV555 required hospitalization or emergency department care. The corresponding rate in the placebo group was 6% (9/150), representing a 72% reduction in risk in this limited population.

Most hospitalized patients carried potential risk factors (age or body mass index), suggesting that LY-CoV555 may have a more pronounced therapeutic effect in these high-risk populations. Ongoing studies will attempt to confirm this finding. In all treatment groups (including the placebo group), no patients progressed to mechanical ventilation or death. Exploratory analyses indicated that patients treated with LY-CoV555 experienced faster symptom improvement.

LY-CoV555 was well tolerated, with no reports of drug-related serious adverse events. Viral RNA sequencing revealed that the incidence of potential LY-CoV555 resistance-associated variants was 8% in the treatment group and 6% in the placebo group.

Eli Lilly plans to rapidly publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with global regulatory authorities. The BLAZE-1 clinical trial is ongoing and will evaluate the efficacy of LY-CoV555 in combination with a second Eli Lilly antibody, LY-CoV016. LY-CoV016 binds to a different antigenic epitope on the SARS-CoV-2 spike protein. The trial is currently enrolling a larger cohort of high-risk patients to assess the ability of the antibody combination to reduce the number of patients with sustained high viral loads and decrease COVID-19-related hospitalizations.

References:

[1] Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting. Retrieved September 16, 2020, from https://investor.lilly.com/news-releases/news-release-details/lilly-announces-proof-concept-data-neutralizing-antibody-ly.

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