Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting
September 16 2020 - 4:56PM
Eli Lilly and Company (NYSE: LLY) today announced proof of concept
data from an interim analysis of the BLAZE-1 clinical trial,
showing a reduced rate of hospitalization for patients treated with
LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2
study evaluated LY-CoV555, a SARS-CoV-2-neutralizing antibody, for
the treatment of symptomatic COVID-19 in the outpatient setting.
The trial enrolled mild- to moderate recently diagnosed COVID-19
patients across four groups (placebo, 700 mg, 2800 mg, and 7000
mg).
The prespecified primary endpoint, change from baseline in viral
load at day 11, was met at the 2800 mg dose level, but not the
others. Most patients, including those receiving placebo,
demonstrated near-complete viral clearance by day 11. Additional
analyses of viral data demonstrated that LY-CoV555 improved viral
clearance at an earlier time point (day 3) and reduced the
proportion of patients with persistently high viral load at later
time points.
These biomarker data correlated with LY-CoV555’s positive impact
on the prespecified endpoint of COVID-19-related hospitalization or
ER visit. This endpoint occurred in 1.7 percent (5/302) of
LY-CoV555 patients, pooled across dose groups, as compared to 6
percent (9/150) of placebo patients, which corresponds to a 72
percent risk reduction in this limited population. Most study
hospitalizations occurred in patients with underlying risk factors
(age or BMI), suggesting a more pronounced treatment effect for
patients in these higher-risk groups. Ongoing studies will seek to
confirm this finding. Across all treatment groups (including
placebo), no patients progressed to mechanical ventilation or died.
Exploratory analyses indicated a more rapid improvement in symptoms
for patients treated with LY-CoV555 versus placebo, supporting the
hospitalization effect.
LY-CoV555 was well-tolerated, with no drug-related serious
adverse events reported. Treatment-emergent adverse events were
similar across all dose groups and comparable to placebo. Viral RNA
sequencing revealed putative LY-CoV555-resistance variants in
placebo and all treatment arms. The rate of resistance variants was
numerically higher in treated patients (8 percent) versus placebo
(6 percent).
“This antibody—LY-CoV555—appears to demonstrate a direct
antiviral effect against SARS-CoV-2, and these early data suggest
it may reduce COVID-related hospitalizations,” said Doron Sagman,
M.D., Lilly Canada's vice president, R&D and medical
affairs. “These results are very encouraging, and we look
forward to generating broader data to gather a fuller understanding
of this antibody’s potential to help in the fight against
COVID-19.”
Lilly intends to quickly publish the results of this interim
analysis in a peer-reviewed journal and discuss appropriate next
steps with global regulators. The BLAZE-1 clinical trial remains
ongoing, testing LY-CoV555 in combination with a second Lilly
antibody, LY-CoV016, which binds a different epitope in the
SARS-CoV-2 spike region. The trial is currently enrolling a larger,
confirmatory cohort of higher-risk patients, testing the ability of
the antibody combination to reduce the number of patients with
persistently high viral load and reduce COVID-related
hospitalizations.
About BLAZE-1BLAZE-1 (NCT04427501) is a
randomized, double-blind, placebo-controlled Phase 2 study designed
to assess the efficacy and safety of LY-CoV555 and LY-CoV016 for
the treatment of symptomatic COVID-19 in the outpatient setting.
Across all treatment arms, the trial will enroll an estimated 800
participants.
The monotherapy arms of the trial enrolled mild- to moderate
recently diagnosed COVID-19 patients across four groups (placebo,
LY-CoV555 700 mg, LY-CoV555 2800 mg, and LY-CoV555 7000 mg). 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 3 days prior to drug infusion.
The primary outcome measure for the BLAZE-1 monotherapy arms 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.
About 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 tested by 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 enrollment and primary safety
assessments of LY-CoV555 in a Phase 1 study of hospitalized
patients with COVID-19 (NCT04411628) and long-term follow-up is
ongoing. A Phase 2 study in people recently diagnosed with
COVID-19 in the ambulatory setting (NCT04427501) is ongoing. Lilly
recently initiated a Phase 3 study for the prevention of COVID-19
in residents and staff at long-term care facilities (NCT04497987).
In addition, LY-CoV555 is being tested in the National Institutes
of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and
hospitalized 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 two partner companies to discover novel antibody
treatments for COVID-19. Lilly intends to test both single-antibody
therapy as well as combinations of antibodies (sometimes known as
antibody cocktails) as potential therapeutics for COVID-19.
About Lilly CanadaEli Lilly and Company is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by Colonel Eli Lilly, who was committed to creating
high quality medicines that meet people’s needs, and today we
remain true to that mission in all our work. Lilly employees work
to discover and bring life-changing medicines to people who need
them, improve the understanding and management of disease, and
contribute to our communities through philanthropy and
volunteerism.
Eli Lilly Canada was established in 1938, the result of a
research collaboration with scientists at the University of Toronto
which eventually produced the world’s first commercially available
insulin. Our work focuses on oncology, diabetes, autoimmunity,
neurodegeneration, and pain. To learn more about Lilly Canada,
please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation,
follow us on twitter @LillyPadCA.
Media Contact:Michael
McDougallmcdougall_michael@lilly.com647-226-3066
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