Second of Lilly’s COVID-19 neutralising antibodies begins Phase I trials

The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.

red antibodies surrounding blue COVID-19 particles

Eli Lilly and Company announced its partner Junshi Biosciences dosed the first healthy volunteer in a study of an investigational neutralising antibody treatment (JS016) designed to fight COVID-19.

JS016 is being co-developed by Junshi and Lilly, with the former leading development in Greater China. Lilly has exclusive rights in the rest of the world and will soon begin dosing patients in a complementary Phase I trial in the US.

Both the Chinese and US Phase I studies aim to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19. Another neutralising anti-SARS-CoV-2 antibody (LY-CoV555) designed by Lilly has already begun Phase I trials in hospitalised COVID-19 patients.

The enterprise said it is planning a clinical development programme which includes a portfolio of monotherapy and combination antibody regimens (cocktails) in order to understand which provide the best efficacy and tolerability in patients. The cocktails will include JS016, LY-CoV555 and other antibodies currently in preclinical development. JS016 and LY-CoV555 bind different epitopes on the spike protein and so should help avoid resistance.

“There is much we still do not know about COVID-19,” said Dr Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “The best path to learn more about the potential for neutralising antibodies, either as monotherapy or in combination, is through carefully controlled randomised trials. We look forward to the results of such trials in the coming months.”

JS016 is a recombinant fully human monoclonal neutralising antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain. Preclinically JS016 has shown the ability to block SARS-CoV-2 binding to the ACE2 host cell surface receptor.