Esperion Completes Enrollment of Pivotal Phase 3 Long-Term Safety and Tolerability Study of Bempedoic Acid in Patients with H...
January 25 2017 - 8:05AM
Approximately 2,000 Patients Enrolled Ahead of Schedule
Following Study Expansion in October 2016Global Study Enrolled
Patients with Hypercholesterolemia with ASCVD and/or HeFH at High
CVD RiskTop-Line Results Expected by Q2 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 completion of patient
enrollment in the global pivotal Phase 3 long-term safety and
tolerability study of bempedoic acid. Enrollment of this study was
completed ahead of schedule in approximately 2,000 patients treated
with bempedoic acid or placebo at high cardiovascular disease (CVD)
risk with hypercholesterolemia whose LDL-C is not adequately
controlled with current lipid-modifying therapies. Top-line results
from this study are expected by Q2 2018.
"We are pleased to have fully enrolled the first of our global
pivotal Phase 3 studies ahead of schedule. This milestone
represents the kind of clinical operational excellence we have come
to expect from our team, our sites and investigators, and our
partner CRO,” said Tim M. Mayleben, president and chief executive
officer of Esperion. “The study was designed by our team of lipid
management experts primarily to understand the long-term safety and
tolerability of bempedoic acid and to also measure the percent
change in LDL-C and other key lipid measures of patients at various
time points throughout the duration of the 52-week study. We look
forward to sharing top-line results by the second quarter of next
year.”
The 52-week global pivotal Phase 3 randomized, double-blind,
placebo-controlled study is evaluating the long-term safety and
tolerability of 180 mg of bempedoic acid versus placebo in patients
with atherosclerotic cardiovascular disease (ASCVD) and/or
heterozygous familial hypercholesterolemia (HeFH) at high CVD risk
whose LDL-C is not adequately controlled with current
lipid-modifying therapies. The study enrolled patients at
approximately 100 sites in the U.S., Canada and Europe. The primary
objective is to assess the safety and tolerability of patients
treated with bempedoic acid for 52 weeks. Secondary objectives
include assessing the LDL-C lowering efficacy of bempedoic acid on
top of maximally tolerated statin and other lipid altering
therapies at 12, 24 and 52 weeks versus placebo. Effects on other
risk markers, including non-high-density lipoprotein cholesterol
(non-HDL-C), total cholesterol, apolipoprotein B (apoB) and high
sensitivity C-reactive protein (hsCRP), will also be evaluated.
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is a
first-in-class, orally available, once-daily ACL inhibitor that
reduces cholesterol biosynthesis and lowers elevated levels of
LDL-C by up-regulating the LDL receptor, but with reduced potential
for muscle-related side effects. Completed Phase 1 and 2 studies in
more than 800 patients treated with bempedoic acid have produced
clinically relevant LDL-C lowering results of up to 30 percent as
monotherapy, approximately 50 percent in combination with
ezetimibe, 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 considered "statin
intolerant". Esperion-discovered and developed, bempedoic acid is a
targeted LDL-C lowering therapy in Phase 3 development. The Company
has two Phase 3 products in development: 1) bempedoic acid
(monotherapy) an oral, once-daily pill, and 2) an, oral, once-daily
fixed dose combination pill of bempedoic acid and ezetimibe
(BA+EZ).
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 CVD; the leading cause of death around the world. Bempedoic
acid, the Company's lead product candidate, is a targeted therapy
that significantly reduces 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, bempedoic acid,
including the Company’s timing, designs, plans, and announcement of
results regarding its global Phase 3 long-term safety and
tolerability program for bempedoic acid. 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, including the risk that 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 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 long-term safety and
tolerability program for bempedoic acid 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 bempedoic acid, and the
risks detailed in Esperion's filings with the Securities and
Exchange Commission. You are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date
of this release. 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 Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
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