The first patients were treated as part of a clinical trial testing whether an antibody therapy can safely reduce 2019 coronavirus disease (COVID-19) severity. The experimental treatment consists of identical copies of an antibody, a blood protein related to those that occur naturally as part of the human immune system, researchers say.
Eli Lilly and Company announced the trial’s start today, with NYU Grossman School of Medicine among the first centers to enroll patients nationally. The phase 1 clinical trial is designed primarily to measure the safety and side effects of the treatment, called LY-CoV555, in patients hospitalized due to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Lilly is developing the treatment in collaboration with AbCellera, which used proprietary drug discovery technologies to analyze antibodies taken from people who recovered from COVID-19. They sought to find the antibodies that most tightly attached to the virus in places known to block its ability to infect human cells (neutralizing antibodies).
Beyond emergency and supportive care, there are currently no U.S. Food and Drug Administration–licensed treatment options for COVID-19, the infection caused SARS-CoV-2.
“We are committed to working with our industry partners to generate scientific evidence from randomized, controlled trials to meet the urgent need for treatments that reduce the severity of COVID-19,” says Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and the Vaccine Center at NYU Langone Health.
“Antibody treatments like the one being studied here hold promise to be highly effective medical countermeasures against this deadly infection,” says Dr. Mulligan, who is also the Thomas S. Murphy Sr. Professor in the Department of Medicine at NYU Langone.
Along with Cedars-Sinai and Emory University, NYU Langone was chosen as one of the first trial centers because it is known for its clinical trials expertise and capacity to rapidly initiate crucial studies, he adds.
“The world urgently needs medicines that can prevent and treat COVID-19,” said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories. “We’re pleased to partner with NYU Langone and other expert centers around the country on this study and are hopeful we can make a meaningful difference in the fight against COVID-19.”
The current treatment candidate was chosen because it is shaped to interact with the “spike proteins” used by SARS-CoV-2 to attach to human cell surfaces, the first step in invading cells, say the investigators. Viruses must enter cells to multiply, and the study treatment is meant to prevent such entry and neutralize the virus.
This randomized, blinded, placebo-controlled, first-in-human study aims to test the safety and tolerability of a single, intravenous dose of LY-CoV555 administered to hospitalized participants. The study will also look at how long the drug candidate lasts in the body.
Women and men aged 18 to 75 years are eligible for the study if they have moderate to severe COVID-19 illness according to National Institutes of Health (NIH) definitions, but not patients at high risk for respiratory failure, the researchers say. Patients will be excluded for several reasons, including if they require intubation (disease too severe), are pregnant, or have serious bacterial or fungal infections.
The study will proceed in stages, with two patients at first randomized to receive by infusion either the lowest dose of LY-CoV555 or placebo. If the drug is safe in that pair after 24 hours, 6 additional patients will be treated. If the lowest dose level in those 8 patients is well tolerated and safe, a group of 8 additional patients would be randomized to receive a slightly higher dose or placebo, with the process repeating for a potential total of up to 32 patients infused over 29 days.
If the treatment proves to be safe at each increasing dose, Lilly plans to pivot to the start of a phase 2 trial, pending regulatory approval, with the potential to test the treatment’s safety in a larger group of patients, including those that have not been hospitalized.