In a news conference yesterday, Eli Lilly provided a comprehensive update of the results of its BLAZE-1 Phase 2 trials for its antibody drug. Based on these, it has applied for Emergency Use Authorization from the FDA, and has the capacity to produce up to 100,000 doses immediately, and scale to 1,000,000 doses prior by the end of 2020. Of particular significance, the focus of Eli Lilly’s development and trials have been on treatment for individual very rapidly after exposure to prevent the development or progression of disease, as well as anticipating future use for treatment prior to exposure for individuals at high risk.
BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of LY-CoV555 and LY-CoV016 for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion. Results showed:
- very significant reduction in viral loads, with complete elimination within a 7 – 11 day course; and
- the benefits stronger the earlier the treatment is started.
For more information, follow the links below.
October 7, 2020 at 12:00 PM EDT
SARS-CoV 2 Neutralizing Antibody Program Update