The first patients have been dosed in a phase 1 trial evaluating a potential antibody therapy designed to treat coronavirus disease 2019 (COVID-19). These patients received treatment at major medical centers in the US, including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
The investigational agent, LY-CoV555, is a potent, neutralizing lgG1 monoclonal antibody directed against the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The randomized, double-blind, placebo-controlled study is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of 1 dose of LY-CoV555 in patients hospitalized with COVID-19; those requiring mechanical ventilation or who have received convalescent COVID-19 plasma treatment prior to enrollment were excluded from the study.
According to the Company, if the phase 1 results show the antibody can be safely administered, the plan will be to move into the next phase of testing, studying the treatment in non-hospitalized COVID-19 patients. Daniel Skovronsky, MD, PhD, and Chief Scientific Officer of Lilly Research Labs said, “Later this month, we will review the results of this first [phase 1] human study and intend to initiate broader efficacy trials.” Lilly also plans to assess the use of LY-CoV555 as a preventive measure for vulnerable patient populations who may not be optimal candidates for vaccines.
“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,” said Dr Skovronsky.
The investigational medicine emerged as a result of a collaboration between Lilly and biotechnology company AbCellera. The antibody was developed shortly after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from a recovered patient.
For more information visit lilly.com.