Eli Lilly (NYSE:LLY) announces positive preliminary data from a Phase 2 clinical trial, BLAZE-1, evaluating LY-CoV555, a SARS-CoV-2 neutralizing antibody, in COVID-19 outpatients with mild-to-moderate symptoms.
The change from baseline in viral load at day 11, the primary endpoint, was met in the 2,800 mg dose arm, but not the others (700 mg, 7,000 mg, placebo). Most patients, including those in the control arm, showed near-complete viral clearance by day 11.
Treatment with LY-CoV555 was associated with improved viral clearance at an earlier time point (day 3) and a lower proportion of patients with persistently high viral load at later time points as well as a lower hospitalization rate.
On the safety front, LY-CoV555 was well-tolerated with no treatment-related serious adverse events and a profile similar to placebo. The rate of putative LY-CoV555 resistance variants (source of drug resistance) was 8% in the treatment group compared to 6% in the placebo group.
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