Esperion Announces Initiation of Phase 2 Triplet Oral Therapy Study of Bempedoic Acid/Ezetimibe/Atorvastatin
March 07 2017 - 8:30AM
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 initiation of a Phase 2
clinical study (1002-038) to assess the efficacy and safety of
triplet oral therapy with bempedoic acid, ezetimibe and
atorvastatin in patients with hypercholesterolemia. This
non-registrational study will enable the Company to explore the
potential market dynamics of these complementary oral LDL-C
lowering therapies together. Top-line results are expected by the
fourth quarter of 2017.
“Our goal is to establish bempedoic acid as the go-to
complementary oral therapy that will provide patients and
physicians with the option to tailor combination therapies with the
convenience of once-daily, oral dosing and the confidence in the
LDL-C lowering and excellent tolerability we’ve come to expect from
bempedoic acid," said Tim M. Mayleben, president and chief
executive officer of Esperion. “We seek to demonstrate in this
Phase 2 triplet oral therapy study of bempedoic acid, ezetimibe and
the most commonly prescribed statin dose, atorvastatin 20 mg,
significant LDL-C reductions, and consistently favorable safety and
tolerability.”
The six-week, Phase 2, randomized, double-blind,
placebo-controlled study will evaluate the efficacy and safety of
180 mg of bempedoic acid, 10 mg of ezetimibe and 20 mg of
atorvastatin (triplet oral therapy) versus placebo. The study is
expected to enroll approximately 60 patients with
hypercholesterolemia at approximately 20 sites across the U.S. The
primary objective of the study is to assess the LDL-C lowering
efficacy of the triplet oral therapy versus placebo. Secondary
objectives include assessing the safety and tolerability of the
triplet oral therapy versus placebo and 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).
“The triplet oral therapy including bempedoic acid, ezetimibe
and atorvastatin could provide a much-needed novel treatment option
for physicians by providing the ability to tailor well-tolerated
multiple oral therapies aimed at helping patients with
hypercholesterolemia achieve their LDL-C goal that could provide a
tolerability advantage,” said Seth J. Baum, M.D., Founder and Chief
Medical Officer of Excel Medical Clinical Trials, LLC and study
investigator. “I look forward to the opportunity to include
patients from our research group in this study, and to seeing the
results later this year.”
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 the 1002-038 Phase 2 clinical study and the
therapeutic potential of triplet oral therapy of bempedoic acid,
ezetimibe and atorvastatin. 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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