INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ -- The New
England Journal of Medicine has published data from the
monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy
and safety of Eli Lilly and Company's (NYSE: LLY) bamlanivimab
(LY-CoV555) – a neutralizing antibody – in the COVID-19 outpatient
setting. This study focused on ambulatory COVID-19 patients being
treated in the outpatient setting, whose symptoms did not require
hospitalization at the time of enrollment. The publication, which
can be found here, follows Lilly's proof-of-concept data
announcement for bamlanivimab as monotherapy in September 2020.
"The publication of these data in a peer-reviewed journal adds
to the growing body of evidence for the potential utility for
neutralizing antibodies as therapeutics for people recently
diagnosed with mild to moderate COVID-19, particularly high-risk
patients," said Ajay Nirula, M.D.,
Ph.D., vice president of immunology at Lilly and co-first author of
the study. "These data show bamlanivimab may be effective in
treating COVID-19 by reducing viral load, symptoms and the risk of
hospitalization in outpatients."
"It is important to treat people with COVID-19 as soon as
possible after diagnosis in order to forestall development of more
severe disease," said Peter Chen,
M.D., director of Pulmonary and Critical Care Medicine at
Cedars-Sinai and co-first author of the study. "Our findings
indicate that neutralizing antibodies may have the potential to be
useful in this early-stage intervention."
These data were submitted as part of Lilly's request for an
emergency use authorization from the U.S. Food and Drug
Administration for bamlanivimab in higher-risk patients who have
been recently diagnosed with mild to moderate COVID-19.
About BLAZE-1
BLAZE-1 (NCT04427501) is a randomized, double-blind,
placebo-controlled Phase 2 study designed to assess the efficacy
and safety of bamlanivimab alone or in combination with a second
antibody for the treatment of symptomatic COVID-19 in the
outpatient setting. To be eligible, patients were required to have
mild or moderate symptoms of COVID-19 as well as a positive
SARS-CoV-2 test based on a sample collected no more than three days
prior to drug infusion.
The monotherapy arms of the trial enrolled mild to moderate
recently diagnosed COVID-19 patients, studying three doses of
bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.
The primary outcome measure for the completed arms of the
BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2
viral load. Additional endpoints include the percentage of
participants who experience COVID-related hospitalization, ER visit
or death from baseline through day 29, as well as safety.
The study is ongoing with additional treatment arms. Across all
treatment arms, the trial will enroll over 800 participants.
Data from the BLAZE-1 study show bamlanivimab may be effective
in treating COVID-19 by reducing viral load, symptoms and the risk
of hospitalization in patients recently diagnosed with mild to
moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse
events were similar between bamlanivimab and placebo, with the
majority being mild to moderate in severity and with no
drug-related serious adverse events reported thus far. In other
bamlanivimab studies, there have been isolated drug-related
infusion reactions or hypersensitivity that were generally mild
(two reported as serious infusion reactions, both patients
recovered).
About bamlanivimab (LY-CoV555)
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. LY-CoV555 emerged 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 less than three months after it was discovered by
AbCellera and the scientists at the National Institute of Allergy
and Infectious Diseases (NIAID) Vaccine Research Center. It was
identified from a blood sample taken from one of the first U.S.
patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab
in hospitalized patients with COVID-19 (NCT04411628). A Phase
2 study in people recently diagnosed with COVID-19 in the
ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3
study of bamlanivimab for the prevention of COVID-19 in residents
and staff at long-term care facilities (BLAZE-2, NCT04497987) is
also ongoing. In addition, bamlanivimab is being tested in the
National Institutes of Health-led ACTIV-2 study of ambulatory
COVID-19 patients.
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical
expertise to attack the coronavirus pandemic around the world.
Existing Lilly medicines are now being studied to understand their
potential in treating complications of COVID-19, and the company is
collaborating with partner companies to discover novel antibody
treatments for COVID-19. Lilly is testing both single antibody
therapy as well as combinations of antibodies as potential
therapeutics for COVID-19. Click here for media resources
related to Lilly's COVID-19 efforts.
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 www.lilly.com/news. 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 bamlanivimab (LY-CoV555) as a potential
treatment for patients with or at risk of infection from
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 studies will complete as planned, that future
study results will be consistent with the results to date, that
bamlanivimab will prove to be a safe and effective treatment
or preventative for COVID-19, that bamlanivimab will receive
regulatory approvals or authorizations, or that we can provide an
adequate supply of bamlanivimab in all circumstances. 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:
|
Molly McCully;
mccully_molly@lilly.com; 317-478-5423 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investors)
|
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SOURCE Eli Lilly and Company