On June 1, Eli Lilly and Company announced patients have been dosed in the world’s first study of an experimental antibody treatment created to fight COVID-19. Lilly worked in partnership with Vancouver-based biotech company AbCellera and the Vaccine Research Center at the U.S National Institute of Allergy and Infectious Diseases (NIAID) to develop this unique treatment.
Unlike other treatments that use pharmaceutical drugs to address the coronavirus infection, Lilly’s antibody treatment harnesses the power of SARS-CoV-2-specific antibodies the human body naturally generates in response to infection. Only a select few of those antibodies properly attack the virus to stop its spread, and Lilly believes it has identified and developed the most effective antibody for COVID-19 treatment and prevention.
About LY-CoV555, Eli Lilly and AbCellera’s Lead Antibody
In March 2020, AbCellera and the NIAID identified SARS-CoV-2 antibodies in a blood sample taken from one of the first U.S patients who recovered from the coronavirus. Over the course of three months, Lilly scientists worked to develop the antibody for use in a new medical treatment.
The antibody, known as 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.
Placebo-Controlled Phase 1 Study is First in Humans
The recently announced Phase 1 trial titled J2W-MC-PYAA is Lilly’s first effort to test LY-CoV555 in humans. It is a randomized, placebo-controlled, double-blind trial designed to “investigate the safety, tolerability, pharmacokinetics (P), and pharmacodynamics (PD) of LY-CoV55,” according to Lilly.
The first patients have been 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 will receive a single dose of the LY-CoV55 antibody.
“Antibody therapies such as LY-CoV555 may have the 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.
Researchers hope to establish the safety of LY-CoV555 during Phase 1. Once that safety is confirmed, Lilly plans to move into the next phase of testing by studying the antibody drug in non-hospitalized coronavirus patients.
“Later this month, we will review the results of this first human study and intend to initiate broader efficacy trials,” explained Skovronksy.
Eli Lilly Ramps Up Antibody Production
In anticipation of positive Phase 1 results, Eli Lilly has initiated large-scale manufacturing of its investigational antibody treatment.
As Skovronsky explained, “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.”