Esperion Announces Initiation of Global Cardiovascular Outcomes Trial for Bempedoic Acid
January 09 2017 - 8:05AM
Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management
company focused on developing and commercializing complementary
oral therapies for the treatment of patients with elevated low
density lipoprotein cholesterol (LDL-C), today announced the
initiation of the global cardiovascular outcomes trial (CVOT) to
assess the effects of bempedoic acid on the occurrence of major
cardiovascular events in patients with, or at high risk for,
cardiovascular disease (CVD) who are only able to tolerate less
than the lowest approved daily starting dose of a statin and
considered “statin intolerant.”
The CVOT – known as Cholesterol
Lowering via BEmpedoic Acid, an
ACL-inhibiting Regimen (CLEAR)
Outcomes – is an event-driven, global, randomized, double-blind,
placebo-controlled study expected to enroll approximately 12,600
patients with hypercholesterolemia and high CVD risk at more than
600 sites in approximately 30 countries. The study is expected to
enroll over a 30-month period with a total estimated study duration
of approximately 4.75 years. The expected average treatment
duration will be 3.5 years with a minimum treatment duration of
approximately 2.25 years. Patients enrolling in the study will be
required to have a history of, or be at high-risk for, CVD with
LDL-C levels between 100 mg/dL and 190 mg/dL despite background
lipid-lowering therapy, resulting in an expected average baseline
LDL-C level in all patients of approximately 135 mg/dL.
"The start of the CLEAR Outcomes CVOT is one of the last and
most exciting steps in the development of bempedoic acid, and we
are very pleased to have begun dosing patients," said Tim M.
Mayleben, president and chief executive officer of Esperion. “We
worked closely with Dr. Steven Nissen and the team at the Cleveland
Clinic to develop this well-powered study to demonstrate the
potential benefit of bempedoic acid in reducing events in a patient
population with a significant unmet need – patients with
hypercholesterolemia considered ‘statin intolerant’ who are at
high-risk for CVD. We believe bempedoic acid has the potential to
provide a well-tolerated, complementary, once-daily, oral therapy
for patients with “statin intolerance” and other high-risk patient
populations with hypercholesterolemia.”
The primary efficacy endpoint of the event-driven global study
is the effect of bempedoic acid versus placebo on the risk of major
adverse cardiovascular events (cardiovascular death, non-fatal
myocardial infarction, non-fatal stroke, hospitalization for
unstable angina, or coronary revascularization; also referred to as
"five-component MACE"). Similar to other CVOTs, CLEAR Outcomes is
designed to provide greater than 85 percent power to detect an
approximately 14 percent relative risk reduction in the primary
endpoint in the bempedoic acid treatment group as compared to the
placebo group, and is expected to complete with a minimum of 1,437
patients experiencing the primary endpoint.
The Company expects to submit a New Drug Application (NDA) for
cardiovascular risk reduction to the U.S. Food and Drug
Administration (FDA) and a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA), on the basis of a
successful completion of the CLEAR Outcomes CVOT, by 2022.
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is a
first-in-class 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 a new convenient and
complementary oral therapy 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
focused on developing and commercializing convenient and
complementary 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, has a targeted
mechanism of action 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 program and timing of an NDA
submission 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 in patient enrollment, the risk
that FDA 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,
the CVOT may not demonstrate that bempedoic acid leads to
cardiovascular risk reduction, 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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