The study is a randomised, placebo-controlled, double-blind Phase 1 clinical trial that evaluates the safety, tolerability of LY-CoV555
Eli Lilly and Company (Lilly) has initiated the first study of an investigational antibody treatment, dubbed LY-CoV555, designed to fight Covid-19.
The J2W-MC-PYAA study is a randomised, placebo-controlled, double-blind Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of LY-CoV555 after a single dose administered to participants hospitalised for Covid-19.
The company has dosed first patients in the study at major medical centres in the US, including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
Lilly intends to expand the J2W-MC-PYAA study into the next phase of testing in non-hospitalised Covid-19 patients, if Phase 1 results show the antibody can be safely administered.
In addition, the company is also planning to study the drug in a preventative setting, focusing on vulnerable patient populations who historically are not optimal candidates for vaccines.
Lilly chief scientific officer and Lilly Research Laboratories president Daniel Skovronsky said: “We are grateful to collaborate with colleagues at AbCellera, NIAID, and the many academic institutions who have helped us reach this milestone in humanity’s fight against Covid-19, a disease first characterized only six months ago.
“We are privileged to help usher in this new era of drug development with the first potential new medicine specifically designed to attack the virus. 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.”
LY-CoV555 is an antibody therapy jointly developed by Lilly and AbCellera
The new investigational medicine LY-CoV555 is a neutralising IgG1 monoclonal antibody (mAb), developed under collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of Covid-19.
The medicine targets the spike protein of SARS-CoV-2, and works by blocking the viral attachment and entry into human cells, enabling potential prevention and treatment of Covid-19.
Lilly claimed that its scientists have rapidly developed the antibody within three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) have isolated it from blood sample of the first US patients recovered from Covid-19.
In addition, LY-CoV555 marks the first potential new medicine that has been designed to precisely target SARS-CoV-2, the virus that causes Covid-19.
Skovronsky added: “Later this month, we will review the results of this first human study and intend to initiate broader efficacy trials. At the same time as we are investigating safety and efficacy, we also are starting large-scale manufacturing of this potential therapy.
“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. “