Eli Lilly and partner AbCellera have advanced a pioneering antibody against SARS-CoV-2’s spike protein into a phase I trial, the first clinical trial of a drug designed specifically to act against the virus that causes COVID-19.
LY-CoV555 initially emerged from a partnership between the NIAID and AbCellera. The partners screened a blood sample from a US patient who had recovered from COVID-19 for promising antibodies. AbCellera subsequently teamed up with Lilly to improve its ability to test and manufacture any resulting candidates. LY-CoV555 aims to prevent the virus from attaching to and entering into human cells, neutralizing the virus and potentially treating and even preventing COVID-19.
The partners anticipate results from the 40-participant phase I safety trial later this month. If safe, they will test the antibody in phase II trials in non-hospitalized COVID-19 patients, as well as in a preventive setting, in vulnerable patient populations. Lilly is also developing other neutralizing antibodies against SARS-CoV-2, and anticipates testing its candidates as both single agents and in antibody cocktails.
Multiple other companies are advancing their own spike-targeting, neutralizing antibodies. Regeneron is aiming to start a phase I trial of its two-antibody cocktail REGN-CoV2 in June; Celltrion plans to move its CT-P59 into phase I in July; GlaxoSmithKline and Vir plan to bypass phase I, with a phase II trial in July; and Amgen and Adaptive Bio are also working on virus-neutralizing antibodies.
The FDA has only approved one virus-targeting antibody to date — green lighting palivizumab for the prevention of respiratory syncytial virus in 1998. Two antibody-based candidates recently reduced mortality from Ebola virus, however. One of these, Regeneron’s REGN-EB3, is currently being reviewed for approval by the FDA.
