INDIANAPOLIS, Sept. 16, 2020 /PRNewswire/ -- 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).
"These interim data from the BLAZE-1 trial suggest that
LY-CoV555, an antibody specifically directed against SARS-CoV-2,
has a direct antiviral effect and may reduce COVID-related
hospitalizations," said Daniel Skovronsky, M.D., Ph.D.,
Lilly's chief scientific officer and president of Lilly Research
Laboratories. "The results reinforce our conviction that
neutralizing antibodies can 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.
"We are grateful to the patients, physicians, and staff that
have participated in this trial," Skovronsky continued. "We look
forward to continued data generation as this trial
proceeds."
About BLAZE-1
BLAZE-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. 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 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 LY-CoV555 will prove to be a safe and
effective treatment or preventative for COVID-19, that LY-CoV555
will receive regulatory approvals, or that we can provide an
adequate supply of LY-CoV555 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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