Eli Lilly announced today that its Phase 1 study of the primary antibody LY-CoV555, developed in collaboration with AbCellera, has been administered to the first patients.
A controlled study with placebo will evaluate the safety and tolerability of COVID-19 in hospitalized patients, with results expected by the end of June.
If the Phase I results indicate that the antibody can be administered safely, Eli Lilly will initiate a Phase II proof-of-concept study to evaluate efficacy in vulnerable populations.
The investigational drug, called LY-CoV555, is the first antibody therapy for the prevention and treatment of COVID-19 developed by Eli Lilly and AbCellera, Inc.
After AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center identified antibodies from blood samples from the first COVID-19 patients in the United States, it took Eli Lilly scientists three months to develop them.
Eli Lilly called LY-CoV555 the first potential new drug to specifically target the SARS-CoV-2 virus.
LY-CoV555 is an effective neutralizing IgG1 monoclonal antibody (mAb) against SARS-CoV-2.
It is designed to block viral attachment and entry into human cells, thereby neutralizing the virus, and thus with possible prevention and treatment of COVID-19.
Eli Lilly intends to test the first antibody and other neutralizing antibodies against SARS-CoV-2 in the coming months, and Eli Lilly also intends to test single antibody therapy and Eli Lilly antibody combination therapy (antibody cocktail therapy) as potential treatments for COVID-19.
J2W-MC-PYAA is a randomized, placebo-controlled, double-blind phase 1 trial investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of LY-CoV555. A single dose of CoV555 was administered to participants who were hospitalized with COVID-19.
The first patients in the study were medicated at several major U.S. medical centers, including the NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
Daniel Skovronsky, Eli Lilly's chief scientific officer and head of the Pharmaceutical Research and Development Laboratory, said thanks for working with colleagues at AbCellera, NIAID, and many academic institutions who helped us reach this milestone in the fight against COVID-19.
Antibody therapies such as LY-CoV555 may have preventive and curative effects, especially in those most affected by the disease, such as the elderly and those with compromised immune systems, Skovronsky said.
"Later this month, we will review the results of this first human study and intend to conduct a broader efficacy trial," he said. As we study safety and efficacy, we will also begin mass production of this potential treatment." Skovronsky said.
"If LY-CoV555 becomes part of the near-term solution for COVID-19, we hope to make it available to patients as soon as possible, with the goal of delivering hundreds of thousands of doses by the end of the year."
If the Phase I results indicate that the antibody is safe to use, Eli Lilly hopes to move on to the next phase of testing to study LY-CoV555 in ambulatory COVID-19 patients.
The company also plans to study the drug in a prophylactic setting, focusing on a vulnerable patient population that has historically not been the best candidate for the vaccine.
Eli Lilly, meanwhile, said in the announcement that he was working on multiple treatments for COVID-19. This includes ongoing collaboration with two biotech companies to discover novel antibody therapies against COVID-19.
Previously, Eli Lilly entered into a collaboration agreement with China's Junshi Biosciences, where the two companies plan to file another clinical trial application and initiate clinical studies for an antibody-drug against a novel coronavirus in China and the United States in the second quarter.
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