In early August, Indianapolis-based drugmaker Eli Lilly and Co announced one of its newest COVID-19 clinical trial initiatives: a late-stage trial testing whether one of its experimental COVID-19 antibody treatments may prevent the spread of infection in U.S nursing homes.
What is Antibody Treatment LY-CoV555?
Eli Lilly is developing its experimental antibody treatment in partnership with Canadian biotech company AbCellera.
The process began in March 2020, when AbCellera and the U.S National Institute of Allergy and Infectious Disease identified SARS-CoV-2 antibodies in a blood sample taken from one of the first U.S patients to recover from the coronavirus. Lilly scientists used those antibodies to develop an experimental antibody treatment currently known as LY-CoV555.
LY-CoV555 is a potent, neutralizing IgG1 monoclonal antibody (mAb). As explained in an Eli Lilly press release, LY-CoV555 is “directed against the spike protein of SARS-CoV-2.” This means the antibody is designed to stop the coronavirus from attaching and entering into human cells. By neutralizing the virus, LY-CoV555 may potentially prevent and treat COVID-19.
The first human participants were dosed with LY-CoV555 in June 2020, marking the world’s first study using an experimental antibody treatment created to fight the coronavirus. It was a randomized, placebo-controlled, double-blind trial designed to “investigate the safety, tolerability, pharmacokinetics (P), and pharmacodynamics (PD) of LY-CoV555,” according to Lilly.
The first patients were dosed with the investigational antibody at major medical centers in the U.S, including Cedars-Sinai in Los Angeles and NYU Grossman School of Medicine. Each participant hospitalized with COVID-19 received a single dose of the LY-CoV555 antibody.
Testing LY-CoV555 in Nursing Homes
Nursing homes have remained extremely vulnerable since the early days of the coronavirus pandemic. Nursing home patients are older, weaker, and often coping with pre-existing health conditions that put them at highest risk of COVID-19 infection.
This is why Eli Lilly is launching a Phase III trial with 2,400 participants who live or work at facilities with recently diagnosed cases of COVID-19. The trial is being conducted in partnership with several long-term care networks across the country, as well as the NIAID. Mobile research units, including retrofitted RVs, can be deployed in response to coronavirus outbreaks at nursing homes across the U.S.
Throughout this study, researchers plan to measure patients’ viral load, or the amount of virus detectable in their blood. This is different from studies designed to prevent hospitalizations and deaths, so the data could be released much faster than usual.
“Antibody therapies such as LY-CoV555 may have potential for both prevention and treatment of COVID-19 and may be particularly important for groups hardest hit by the disease such as the elderly and those with compromised immune systems,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.
Skovronsky added, “If LY-CoV555 becomes part of the near-term solution for COVID-19, we want to be ready to deliver it to patients as quickly as possible, with the goal of having several hundred thousand doses available by the end of the year.”