Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting.

Eli Lilly and Company announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555 . The randomized, double-blind, placebo-controlled Phase II study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg). The prespecified primary endpoint, change from baseline in viral load at day 11, was met at the 2800 mg dose level, but not the others. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Additional analyses of viral data demonstrated that LY-CoV555 improved viral clearance at an earlier time point (day 3) and reduced the proportion of patients with persistently high viral load at later time points. These biomarker data correlated with LY-CoV555's positive impact on the prespecified endpoint of COVID-19-related hospitalization or ER visit. This endpoint occurred in 1.7 percent (5/302) of LY-CoV555 patients, pooled across dose groups, as compared to 6 percent (9/150) of placebo patients, which corresponds to a 72 percent risk reduction in this limited population. Most study hospitalizations occurred in patients with underlying risk factors (age or BMI), suggesting a more pronounced treatment effect for patients in these higher-risk groups. Ongoing studies will seek to confirm this finding. Across all treatment groups (including placebo), no patients progressed to mechanical ventilation or died. Exploratory analyses indicated a more rapid improvement in symptoms for patients treated with LY-CoV555 versus placebo, supporting the hospitalization effect. LY-CoV555 was well-tolerated, with no drug-related serious adverse events. LY-CoV555 was well-tolerated, with no drug-related serious adverse events reported. Treatment emergent adverse events were similar across all dose groups and comparable to placebo. Viral RNA sequencing revealed putative LY-CoV555-resistance variants in placebo and all treatment arms. The rate of resistance variants was numerically higher in treated patients (8 percent) versus placebo (6 percent). Lilly's LY-CoV555 is one of several antibody treatments now in testing, and its data is the first clinical evidence to emerge suggesting these drugs may be helpful in treating COVID-19..