– Top-Line Results Expected by the Fourth Quarter
of 2018 –
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 initiation of the pivotal
Phase 3 study (1002FDC-053) to assess the efficacy and safety of
the bempedoic acid / ezetimibe combination pill in patients with
hypercholesterolemia and atherosclerotic cardiovascular disease
(ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH),
including high cardiovascular risk primary prevention patients,
whose LDL-C is not adequately controlled despite receiving
maximally tolerated lipid-modifying background therapy. Top-line
results are expected by the fourth quarter of 2018.
“Initiating the pivotal Phase 3 study for the
bempedoic acid / ezetimibe combination pill puts us on track to
report results from all five pivotal Phase 3 studies for the
bempedoic acid franchise in 2018,” said Tim M. Mayleben, president
and chief executive officer of Esperion. “The bempedoic acid /
ezetimibe combination pill and bempedoic acid are the only
convenient, complementary, cost-effective, once-daily, oral
therapies in late-stage development for the millions of high-risk
patients with hypercholesterolemia who are inadequately treated
with, or unable to gain access to, current lipid-modifying
therapies.”
The 12-week, pivotal Phase 3, randomized,
double-blind, placebo-controlled, parallel-dose study will consist
of four treatment arms evaluating the efficacy and safety of a
once-daily, oral, fixed dose combination pill of 180 mg of
bempedoic acid and 10 mg of ezetimibe versus placebo, 180 mg of
bempedoic acid alone and 10 mg of ezetimibe alone. The study is
expected to enroll approximately 350 patients at up to 125 U.S.
sites. The co-primary objectives of the study are to assess LDL-C
lowering efficacy in patients treated with the bempedoic acid /
ezetimibe combination pill versus placebo, 180 mg of bempedoic acid
and 10 mg of ezetimibe alone. Secondary objectives include
assessing the safety and tolerability of the bempedoic acid /
ezetimibe combination pill versus placebo, 180 mg of bempedoic acid
and 10 mg of ezetimibe alone and effects on other risk markers,
including high sensitivity C-reactive protein (hsCRP),
non-high-density lipoprotein cholesterol (non-HDL-C),
apolipoprotein B (apoB) and total cholesterol.
“As a physician, I am intrigued by the
opportunity for these therapies to complement the standard of care
and drive LDL-cholesterol levels even lower for my patients. Having
a single pill that contains both bempedoic acid and ezetimibe that
can be taken orally once daily would be a welcome addition to my
treatment armamentarium,” said Christie M. Ballantyne, MD,
Professor and Chief of Cardiology at Baylor College of
Medicine and study investigator. “Patients need more oral
LDL-cholesterol lowering options to help them reach their goals,
and both the fixed dose combination of bempedoic acid and
ezetimibe, and bempedoic acid alone could satisfy their roles as
patient-friendly, physician-friendly and payer-friendly
choices.”
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
1,300 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, clinical development plan for, the
bempedoic acid / ezetimibe combination pill and bempedoic acid,
including Esperion’s timing, designs, plans and announcement of
results regarding the pivotal Phase 3 study (1002FDC-053). 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 Esperion’s studies, including the
risk that Esperion may need to change the design of its pivotal
Phase 3 study, that existing cash resources may be used more
quickly than anticipated, that the pivotal Phase 3 study may not
produce sufficient safety or tolerability results or show
meaningful change in LDL-C or other key lipid measures of patients,
or the risk that other unanticipated developments or data could
interfere with the scope of development and commercialization of
the bempedoic acid / ezetimibe combination pill and bempedoic acid,
and the 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 Group
212.257.6724efox@w2ogroup.com
Investor Contact: Mindy LoweEsperion Therapeutics,
Inc.734.887.3903mlowe@esperion.com
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