Lilly Begins Study for Second Potential COVID-19 Antibody Treatment

Eli Lilly and Company announced its 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, referred to as 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 complementary Phase 1 study in the United States 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."

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. The project is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science, with Junshi Biosciences leading development in Greater China and Lilly leading development in the rest of the world.