– Pivotal Phase 3 Top-Line Results for Bempedoic
Acid Expected in the Second and Third Quarters of 2018 –– NDA
Submission for LDL-C Lowering Indication for Bempedoic Acid Planned
by First Quarter 2019 –
Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management
Company focused on developing and commercializing convenient,
complementary, cost-effective, once-daily, oral therapies for the
treatment of patients with elevated low density lipoprotein
cholesterol (LDL-C), today announced the completion of patient
enrollment in the global pivotal phase 3 program for bempedoic
acid. Top-line results from Studies 1, 3 and 4 are expected in the
second quarter of 2018, with top-line results from Study 2 expected
in the third quarter of 2018. The pivotal Phase 3 program for the
bempedoic acid / ezetimibe combination pill remains on track to
initiate this quarter, with top-line results expected by the fourth
quarter of 2018. The four Phase 3 studies comprising the global
pivotal Phase 3 program for bempedoic acid along with the single
Phase 3 bridging study for the combination pill are expected to
support two New Drug Application (NDA) submissions for LDL-C
lowering indications for the bempedoic acid / ezetimibe combination
pill and bempedoic acid by the first quarter of 2019.
“There are approximately 25 million patients
living with hypercholesterolemia in the U.S. and Europe who are
inadequately treated with current lipid-modifying therapies,
including those patients who are unable to tolerate less than the
lowest approved daily starting dose of statins or who are unable to
access the therapies they need,” said Tim Mayleben, president and
chief executive officer of Esperion Therapeutics. “The tremendous
progress made by our Lipid Management Team to rapidly enroll our
global pivotal Phase 3 program for bempedoic acid is a significant
step forward as we continue to progress toward the goal of
providing these patients and their physicians with once-daily, oral
options to lower LDL-C, especially for those whose therapeutic and
economic needs are not currently being met, as we approach the most
eventful and transformative year yet for Esperion in 2018.”
Bempedoic Acid Global Pivotal Phase 3
Program
The ongoing Phase 3 program for bempedoic acid
includes four global pivotal studies that enrolled almost 3,600
high cardiovascular disease (CVD) risk patients with
hypercholesterolemia and atherosclerotic cardiovascular disease
(ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH),
or who are high risk primary prevention, on optimized background
lipid-modifying therapy and with elevated levels of LDL-C. These
patients are on two distinct types of background lipid-modifying
therapy: 1) patients on their maximally tolerated statin therapy,
and 2) patients only able to tolerate less than the lowest approved
daily starting dose (e.g., patients considered statin
intolerant).
Global Pivotal Phase 3 Study
1: This 52-week long-term safety and tolerability
study fully enrolled 2,230 patients with ASCVD and/or HeFH whose
LDL-C is not adequately controlled with current lipid-modifying
therapies, and who are taking maximally tolerated statin therapy.
Top-line results are expected to be announced by the second quarter
of 2018.
Global Pivotal Phase 3 Study 2:
This 52-week LDL-C lowering efficacy and safety study fully
enrolled 779 patients with ASCVD and/or HeFH whose LDL-C is not
adequately controlled with current lipid-modifying therapies, and
who are taking maximally tolerated statin therapy. Top-line results
are expected to be announced by the third quarter of 2018.
Global Pivotal Phase 3 Study 3:
This 24-week LDL-C lowering efficacy study fully enrolled 345 high
CVD risk patients with ASCVD and/or HeFH, or who are high risk
primary prevention, whose LDL-C is not adequately controlled with
current lipid-modifying therapies, and who are only able to
tolerate less than the lowest approved daily starting dose of a
statin and considered statin intolerant. Top-line results are
expected to be announced by the second quarter of 2018.
Global Pivotal Phase 3 Study 4:
This 12-week LDL-C lowering efficacy study fully enrolled 227 high
CVD risk patients with ASCVD and/or HeFH, whose LDL-C is not
adequately controlled with current lipid-modifying therapies,
including ezetimibe, and who are only able to tolerate the lowest
approved daily starting dose of a statin and considered statin
intolerant. Top-line results are expected to be announced by the
second quarter of 2018.
Bempedoic Acid / Ezetimibe Combination
Through the complementary mechanisms of action
of inhibition of cholesterol synthesis (bempedoic acid) and
inhibition of cholesterol absorption (ezetimibe), the bempedoic
acid / ezetimibe combination pill is our lead, non-statin, orally
available, once-daily, LDL-C lowering therapy. Inhibition of ATP
Citrate Lyase (ACL) by bempedoic acid reduces cholesterol
biosynthesis and lowers LDL-C by up-regulating the LDL receptor.
Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results
in reduced absorption of cholesterol from the gastrointestinal
tract, thereby reducing delivery of cholesterol to the liver, which
in turn upregulates LDL receptors. Previously completed Phase 2
data demonstrated that this safe and well tolerated combination
results in a 48 percent lowering of LDL-C, a 26 percent reduction
in high sensitivity C-reactive protein (hsCRP), and may potentially
be associated with a lower occurrence of muscle-related side
effects.
Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, complementary, orally available,
once-daily ACL inhibitor that reduces cholesterol biosynthesis and
lowers LDL-C by up-regulating the LDL receptor, and may potentially
be associated with a lower occurrence of muscle-related side
effects. Completed Phase 1 and 2 studies conducted in approximately
1,200 patients and over 800 patients treated with bempedoic acid
have produced clinically relevant LDL-C lowering results of up to
30 percent as monotherapy and an incremental 20+ percent when added
to stable statin therapy.
Esperion's Commitment to Patients with
Hypercholesterolemia
In the United States, 78 million people, or more
than 20 percent of the population, have elevated LDL-C; an
additional 73 million people in Europe and 30 million people in
Japan also live with elevated LDL-C. Esperion's mission as the
Lipid Management Company is to provide patients and physicians with
convenient, complementary, cost-effective, once-daily, oral
therapies to significantly reduce elevated levels of LDL-C in
patients inadequately treated with current lipid-modifying
therapies. It is estimated that 40 million patients in the
U.S. are taking statins with approximately 5-20 percent of
these patients only able to tolerate less than the lowest approved
daily starting dose of their statin and are therefore considered to
be statin intolerant. Esperion-discovered and developed, bempedoic
acid is a targeted LDL-C lowering therapy in Phase 3 development.
The company has two convenient, cost-effective, complementary,
orally available, LDL-C lowering therapies in Phase 3 development:
1) a once-daily, oral bempedoic acid / ezetimibe combination pill,
and 2) bempedoic acid, a once-daily, oral pill.
The Lipid Management Company
Esperion Therapeutics, Inc. is the Lipid
Management Company passionately committed to developing and
commercializing convenient, complementary, cost-effective,
once-daily, oral therapies for the treatment of patients with
elevated LDL-C. Through scientific and clinical excellence, and a
deep understanding of cholesterol biology, the experienced lipid
management team at Esperion is committed to developing new LDL-C
lowering therapies that will make a substantial impact on reducing
global cardiovascular disease; the leading cause of death around
the world. Bempedoic acid and the company's lead product candidate,
the bempedoic acid / ezetimibe combination pill, are targeted
therapies that have been shown to significantly reduce elevated
LDL-C levels in patients with hypercholesterolemia, including
patients inadequately treated with current lipid-modifying
therapies. For more information, please
visit www.esperion.com and follow us on Twitter
at https://twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking
statements that are made pursuant to the safe harbor provisions of
the federal securities laws, including statements regarding the
therapeutic potential of, and clinical development plan for, the
bempedoic acid / ezetimibe combination and bempedoic acid,
including the Company’s timing, designs, plans and announcement of
results regarding its Phase 3 program and the Company’s cash
position and financial outlook. Any express or implied statements
contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Forward-looking statements involve risks and uncertainties that
could cause Esperion's actual results to differ significantly from
those projected, including, without limitation, delays or failures
in the Company’s studies, the U.S. Food and Drug Administration may
require additional studies or data, that Esperion may need to
change the design of its Phase 3 program, that positive results
from a clinical study of the bempedoic acid / ezetimibe combination
and bempedoic acid may not necessarily be predictive of the results
of future clinical studies, particularly in different or larger
patient populations, that existing cash resources may be used more
quickly than anticipated, that Esperion’s global Phase 3 program
for bempedoic acid may not produce positive results, or that other
unanticipated developments or data could interfere with the scope
of development and commercialization of the bempedoic acid /
ezetimibe combination and bempedoic acid, and the other risks
detailed in Esperion's filings with the Securities and Exchange
Commission. Esperion disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this
press release, other than to the extent required by law.
Media Contact:Elliot FoxW2O
Group212.257.6724efox@w2ogroup.com
Investor Contact: Mindy LoweEsperion Therapeutics,
Inc.734.887.3903mlowe@esperion.com
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