Eli Lilly Begins Dosing in Phase 1 Study of Second Potential COVID-19 Antibody Treatment

Eli Lilly and Company (Indianapolis, Ind, USA) has announced that its partner Shanghai Junshi Biosciences Co. Ltd. (Shanghai, China) has dosed the first healthy volunteer in a study of a potential neutralizing antibody treatment designed to fight COVID-19.

The investigational medicine, referred to as JS016, is being co-developed by Junshi Biosciences and Lilly. JS016 is a recombinant fully human monoclonal neutralizing antibody, which has been modified to diminish effector function. JS016 specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain and can effectively block the binding of viruses to the ACE2 host cell surface receptor.

Junshi Biosciences is leading its development in Greater China, while Lilly has exclusive rights in the rest of the world and will begin dosing patients in a complementary Phase 1 study in the US in the coming days. Both Phase 1 studies aim to 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 1 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 (the latter often referred to as antibody "cocktails") 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.

"There is much we still don't know about COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "The best path to learn more about the potential for neutralizing antibodies, either as monotherapy or in combination, is through carefully controlled randomized trials. We look forward to the results of such trials in the coming months."

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