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US Pharma Giant Eli Lilly Initiates Phase 3 Trial of Its Experimental Antibody Drug LY-CoV555 for Prevention of COVID-19
European Pharma Association
US pharmaceutical giant Eli Lilly on Monday (Aug 4) announced that it has commenced Phase 3 trial of its experimental antibody drug LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S.
Antibodies are typically proteins the body produces in response to invasion of a foreign substance such as a virus. They can be obtained from the blood of recovered patients or created in the laboratory from genetic sequences.
LY-CoV555, the lead antibody developed by Lilly in collaboration with AbCellera, is positioned as a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. It is being developed to serve as a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.
LY-CoV555 is designed to work by blocking viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly's Phase 3 trial is being conducted in partnership with NIAID, part of the National Institutes of Health (NIH), along with the COVID-19 Prevention Network (CoVPN) and several long-term care facility networks across the country. The study will enroll residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who are now at a high risk of exposure.
It will evaluate the efficacy and safety of LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19, testing whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through 4 weeks, as well as complications of COVID-19 through 8 weeks. It is expected to enroll up to 2,400 participants.
The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population.
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