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Lilly and Junshi Biosciences Initiate Phase I COVID-19 Trials

Studies will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19.

By: Contract Pharma

Contract Pharma Staff

Eli Lilly and Co’s partner Junshi Biosciences has dosed the first healthy volunteer in a study of a potential neutralizing antibody treatment designed to fight COVID-19.

The investigational medicine, JS016, is being co-developed by Junshi Biosciences and Lilly, with Junshi Biosciences leading development in Greater China. Lilly has exclusive rights in the rest of the world and will begin dosing patients in a Phase I study in the U.S. in the coming days. Both Phase I studies will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19. This is Lilly’s second neutralizing antibody to start clinical trials, following LY-CoV555 that recently entered Phase I and is currently being tested in hospitalized COVID-19 patients.

Lilly is planning a clinical development program which includes a portfolio of monotherapy and combination antibody regimens in order to understand which provide the best efficacy and tolerability in patients. These cocktails will include JS016, LY-CoV555, as well as additional antibodies currently in preclinical development. JS016 and LY-CoV555 bind different epitopes on the spike protein and thus expand the diversity of options for achieving efficacy and avoiding resistance.

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