Eli Lilly’s partner Junshi Biosciences has dosed the first healthy volunteer in a study of a potential neutralising antibody treatment, known as JS016, to treat Covid-19 disease.
Junshi and Lilly are involved in the development of the JS016 investigational medicine, while Junshi is taking responsibility for the development in Greater China.
Lilly, which has exclusive rights in the rest of the world, will soon commence dosing patients in a complementary phase 1 study in the US.
The JS016 is a recombinant fully human monoclonal neutralising antibody, which has been altered to lower effector function. It specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain and can efficiently restrict the binding of viruses to the ACE2 host cell surface receptor.
Both phase 1 studies will assess the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with the Covid-19 disease.
Lilly stated that it is the second neutralising antibody to begin clinical trials, following LY-CoV555 that recently entered phase 1 and is presently being assessed in hospitalised Covid-19 patients.
Lilly is planning to create a clinical development programme that includes a portfolio of monotherapy and combination antibody regimens to better the best efficacy and tolerability in patients.
The programme will comprise of JS016, LY-CoV555, as well as additional antibodies presently in preclinical development.
The JS016 and LY-CoV555 are said to bind different epitopes on the spike protein, enabling to extend the options to achieve efficacy and avoid resistance.
Lilly Research Laboratories chief scientific officer and president Dr Daniel Skovronsky said: “The best path to learn more about the potential for neutralizing 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.”
In April, Eli Lilly started clinical testing of its oral JAK1/JAK2 inhibitor OLUMIANT (baricitinib) and investigational candidate LY3127804 in separate Covid-19 trials.