Key findings from the interim data of Lilly's randomized, double-blind, placebo-controlled Phase 2 study, BLAZE-1, include that the primary endpoint of viral load change from baseline at day 11 was met for one of three doses; consistent effects of viral reduction seen at earlier time points.
The rate of hospitalizations and ER visits was 1.7 % (5/302) for LY-CoV555 vs. 6 % (9/150) for placebo - a 72% risk reduction in this limited population.
LY-CoV555 was well-tolerated across all doses with no drug-related serious adverse events reported
LY-CoV555 is developed from an antibody that was identified from the blood of a recovered COVID-19 patient using AbCellera's pandemic response platform.
Within one week of receiving the sample, AbCellera screened over 5 m antibody-producing cells to identify and isolate approximately 500 unique antibodies that bind to SARS-CoV-2, the virus that causes COVID-19.
Together with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) and Lilly, those antibodies were tested to find the ones most effective in neutralizing the virus.
LY-CoV555 was selected as the lead candidate from this group of antibodies, and is the world's first therapeutic candidate specifically developed against SARS-CoV-2 to enter human clinical trials.
AbCellera's pandemic response capabilities were developed over the past two years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform program.
The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen.
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.
It is designed to block viral attachment and entry into human cells, thus neutralising the virus and potentially preventing and treating COVID-19. LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.
Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.
AbCellera is a privately held technology company with an antibody discovery platform that searches and analyzes natural immune systems to find antibodies that can be used to prevent and treat disease.
AbCellera's technology, which combines high-throughput microfluidics, hyper-scale data science, machine learning, bioinformatics, and genomics, identifies new drug candidates and aims to reduce the time it takes to bring treatments to the clinic.
AbCellera's partners include leading biotechnology companies, global health organizations, and many of the top 10 biopharmaceutical companies.
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