INDIANAPOLIS, June 1, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced patients have been dosed in the
world's first study of a potential antibody treatment designed to
fight COVID-19.
This investigational medicine, referred to as LY-CoV555, is the
first to emerge from the collaboration between Lilly and AbCellera
to create antibody therapies for the prevention and treatment of
COVID-19. Lilly scientists rapidly developed the antibody in just
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 U.S.
patients who recovered from COVID-19. LY-CoV555 is the first
potential new medicine specifically designed to attack SARS-CoV-2,
the virus that causes COVID-19.
The first patients in the study were dosed at major medical
centers in the U.S., including NYU Grossman School of Medicine and
Cedars-Sinai in Los Angeles.
"We are committed to working with our industry partners to
generate scientific evidence to meet the urgent need for treatments
that reduce the severity of COVID-19 disease," said Mark J. Mulligan, MD, director of the Division
of Infectious Diseases and Immunology and director of the Vaccine
Center at NYU Langone Health. "Antibody treatments like the one
being studied here hold promise to be effective medical
countermeasures against this deadly infection," said Dr. Mulligan,
also the Thomas S. Murphy, Sr. Professor in the Department of
Medicine at NYU Langone.
"We are grateful to collaborate with colleagues at AbCellera,
NIAID, and the many academic institutions who have helped us reach
this milestone in humanity's fight against COVID-19 — a disease
first characterized only six months ago. We are privileged to help
usher in this new era of drug development with the first potential
new medicine specifically designed to attack the virus. Antibody
therapies such as LY-CoV555 may have potential for both prevention
and treatment of COVID-19 and may be particularly important for
groups hardest hit by the disease such as the elderly and those
with compromised immune systems," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief
scientific officer and president of Lilly Research
Laboratories.
"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. 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," continued Skovronsky.
Should Phase 1 results show the antibody can be safely
administered, Lilly expects to move into the next phase of testing,
studying LY-CoV555 in non-hospitalized COVID-19 patients. The
company also plans to study the drug in a preventative setting,
focusing on vulnerable patient populations who historically are not
optimal candidates for vaccines.
Lilly is researching multiple approaches to treating COVID-19.
Existing Lilly medicines are now being studied to understand their
potential in treating complications of COVID-19, and the company is
collaborating with two biotech companies to discover novel antibody
treatments for COVID-19.
About Lilly's SARS-CoV-2 Antibody Program
LY-CoV555
is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed
against the spike protein of SARS-CoV-2. It is designed to block
viral attachment and entry into human cells, thus neutralizing the
virus, potentially preventing and treating COVID-19. Lilly intends
to test this first antibody as well as other neutralizing
antibodies against SARS-CoV-2 over the next several
months. Lilly intends to test both single antibody therapy as
well as combinations of Lilly antibodies (sometimes known as
antibody cocktails) as potential therapeutics for COVID-19.
About the LY-CoV555 Phase 1 Trial
Study J2W-MC-PYAA is
a randomized, placebo-controlled, double-blind Phase 1 trial that
aims to investigate the safety, tolerability, pharmacokinetics
(PK), and pharmacodynamics (PD) of LY-CoV555 following a single
dose administered to participants hospitalized for COVID-19.
About Eli Lilly and Company
Lilly is a
global healthcare leader that unites caring with discovery to
create medicines that make life better for people around the world.
We were founded more than a century ago by a man committed to
creating high-quality medicines that meet real needs, and today we
remain true to that mission in all our work. Across the globe,
Lilly employees work to discover and bring life-changing medicines
to those who need them, improve the understanding and management of
disease, and give back to communities through philanthropy and
volunteerism. To learn more about Lilly, please visit us
at www.lilly.com and newsroom.lilly.com/social-channels. P-LLY
Lilly Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements (as that term is defined in the Private Securities
Litigation Reform Act of 1995) about LY-CoV555 as a potential
treatment for patients with COVID-19 and reflects Lilly's current
beliefs. However, as with any such undertaking, there are
substantial risks and uncertainties in the process of drug
development and commercialization. Among other things, there can be
no guarantee that LY-CoV555 will prove to be an effective treatment
for COVID-19. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Refer
to:
|
Nicole Hebert;
Nicole_Hebert@lilly.com; +1-317-701-9984 (media)
|
|
Kevin Hern;
Hern_Kevin_r@lilly.com; +1-317-277-1838 (investors)
|
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SOURCE Eli Lilly and Company