Eli Lilly Begins Phase 3 Trial of Human Antibody LY-CoV555 for Prevention of COVID-19

(Vancouver, Canada), 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 was identified from a blood sample taken from one of the first US patients who recovered from COVID-19. Lilly has successfully completed dosing of LY-CoV555 in a Phase 1 study of hospitalized patients with COVID-19 (NCT04411628) and long-term follow-up is ongoing. BLAZE-1, a Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (NCT04427501), is ongoing.

The Lilly-sponsored BLAZE-2 study is a first-of-its-kind COVID-19 trial and is being conducted in partnership with the National Institute of Allergy and Infectious Diseases (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 US. 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 four weeks, as well as complications of COVID-19 through eight weeks. The study 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.

To address the challenging aspects of running a clinical trial in a long-term care facility during a pandemic, Lilly created customized mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle (RV) to support mobile labs and clinical trial material preparation, along with a trailer truck that will deliver all clinical trial supplies needed to create an on-site infusion clinic. To further minimize the burden on these facilities that normally do not conduct clinical trials, additional staff will be at the facilities to assist with the operations of the study. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the US.

"COVID-19 has had a devastating impact on nursing home residents. We're working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals. While it's not easy to conduct clinical trials in this setting, we're taking on the challenge in an effort to help those who need us the most," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories.

"The mission of the COVID-19 Prevention Network is to conduct Phase 3 vaccine and monoclonal antibody efficacy studies for the prevention of COVID-19," said Myron Cohen, M.D., director of UNC's Institute for Global Health and Infectious Diseases and a CoVPN leader. "We're excited to partner with Lilly to determine whether LY-CoV555 can prevent or mitigate progression of COVID-19 infection in this vulnerable population that has been greatly impacted by this virus."

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