Phase 1 Study Starts for Lilly’s Second COVID-19 Antibody Treatment

June 10, 2020 - Eli Lilly and Company recently announced that its partner, Junshi Biosciences, dosed the first healthy volunteer in a study of a potential COVID-19 antibody treatment.

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The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of the investigational medicine, JS016, in healthy participants who have not been diagnosed with COVID-19.

Lilly has exclusive rights in the rest of the world and will begin dosing patients in the US study in the coming days. 

JS016 is a fully human monoclonal neutralizing antibody that is specific to this strain of coronavirus surface spike protein receptor-binding domain, Lilly said.

Antibodies can effectively block the binding of viruses to host cell surface receptor ACE2. 

Experts are actively looking to pursue antibody treatments as a complementary tool to fight COVID-19.

Unlike vaccines, antibody treatments don’t produce lasting protection against a disease. Instead, these treatments are meant to equip bodies with tools to immediately fight off an infection, or prevent an imminent contagion. 

At the beginning of May, Eli Lilly and Junshi entered into an agreement to co-develop COVID-19 antibody therapies for COVID-19.

The biopharmaceutical companies will submit an investigational new drug (IND) application and initiate clinical studies in the US in the second quarter of the year. Junshi said it will keep contact with the Center for Drug Evaluation of the National Medical Products Administration to initiate the IND application submission in China as soon as possible.

With the help of Lilly, Junshi’s CEO Ning Li, MD, PhD, anticipates a faster track to clinical development.

The most recent Lilly announcement stated that the company is planning a clinical development program that includes a portfolio of monotherapy and combination antibody regimens (cocktails) to better understand which provide the best efficacy and tolerability in patients. 

These cocktails will include JS016 and other additional antibodies currently in preclinical development. 

"There is much we still don't know about COVID-19,"  Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said in the announcement. 

"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."

This is Lilly's second neutralizing antibody to start clinical trials.

Earlier this week, Eli Lilly announced that patients have been dosed in the world’s first study of potential COVID-19 antibody treatments. 

LY-CoV555 is the first investigational medicine produced from the partnership between Eli Lilly and AbCellera to create antibody therapies to treat coronavirus.

Lilly researchers developed the antibody in three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first US patients who recovered from COVID-19.

“Later this month, we will review the results of this first human study and intend to initiate broader efficacy trials. At the same time as we are investigating safety and efficacy, we also are starting large-scale manufacturing of this potential therapy,” said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories.

“If LY-CoV555 becomes part of the near-term solution for COVID-19, we want to be ready to deliver it to patients as quickly as possible, with the goal of having several hundred thousand doses available by the end of the year.”