
More About Lilly’s mAb Therapy for COVID-19
- Posted by ISPE Boston
- On September 30, 2020
Eli Lilly has 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 SARS-CoV-2 neutralizing antibody LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 for the treatment of symptomatic COVID-19 in the outpatient setting.
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, 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 tested by the 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 U.S. patients who recovered from COVID-19.
“These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19.”
Lilly intends to quickly publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with global regulators. The BLAZE-1 clinical trial remains ongoing, testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region. The trial is currently enrolling a larger, confirmatory cohort of higher risk patients, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations. (Source: Eli Lilly Website, 16 September, 2020)
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