Esperion Therapeutics Announces Initiation of Phase 3 Clinical Program With Long-Term Safety and Tolerability Study
January 13 2016 - 8:30AM
Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company
focused on developing and commercializing first-in-class, oral,
low-density lipoprotein cholesterol (LDL-C) lowering therapies for
the treatment of patients with hypercholesterolemia, today
announced the start of a global Phase 3 long-term safety and
tolerability study (ETC-1002-040) of bempedoic acid in patients
with hyperlipidemia whose LDL-C is not adequately controlled with
low- and moderate-dose statins. This study will enable the Company
to understand the 52 week safety profile of bempedoic acid, and
top-line results are expected in the fourth quarter of 2017.
ETC-1002-040 is a Phase 3 randomized,
multicenter, double-blind, placebo-controlled study evaluating 180
mg of bempedoic acid versus placebo in 900 patients with
hyperlipidemia at high cardiovascular disease risk and whose LDL-C
is not adequately controlled with maximally tolerated
lipid-modifying therapy. The study will enroll patients at
approximately 125 sites in the U.S., Canada and the European Union.
The primary objective is to assess safety and tolerability of
patients treated with bempedoic acid for 52 weeks. Secondary
objectives include assessing the effects of bempedoic acid on other
lipid and cardiometabolic risk markers, including LDL-C and
high-sensitivity C-reactive protein.
This study marks the launch of the Phase 3
clinical program – known as Cholesterol
Lowering via ETC-1002, an
ACL-inhibiting Regimen (CLEAR) –
which will be focused on the development of bempedoic acid for
statin intolerant patients with uncontrolled LDL-C levels. The
Company will provide details of the full Phase 3 global development
strategy in the second quarter of 2016. Separately, the Company
anticipates formalizing and communicating the design of the planned
cardiovascular outcomes trial in the second quarter of 2016.
“We are pleased to announce the launch of our
Phase 3 program, CLEAR, with the initiation of this long-term
safety study,” said Tim M. Mayleben, president and chief executive
officer of Esperion. “We continue to make progress with regulatory
authorities to finalize the Phase 3 global development strategy,
and data from this study will help confirm the safety profile of
bempedoic acid over the long term, which is foundational for this
program.”
Esperion’s Commitment to Cardiometabolic
Disease
Esperion is committed to improving the lives of patients with
hypercholesterolemia by developing therapies to lower LDL-C.
Esperion scientists discovered bempedoic acid and the LDL-C
lowering therapy is in late stage development. Esperion plans to
develop both bempedoic acid and a fixed dose combination of
bempedoic acid and ezetimibe with a particular focus on patients
with hypercholesterolemia who are considered intolerant of statin
therapy. It is estimated that approximately 10% of patients who are
prescribed statins, 3.5 million patients in the U.S., are
considered statin intolerant.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a
pharmaceutical company focused on developing and commercializing
first-in-class, oral, LDL-C lowering therapies for the treatment of
patients with hypercholesterolemia. Bempedoic acid, the Company’s
lead product candidate, is an inhibitor of ATP Citrate Lyase, a
well-characterized enzyme on the cholesterol biosynthesis pathway.
Bempedoic acid inhibits cholesterol synthesis, decreases
intracellular cholesterol, up-regulates LDL-receptors, and causes
increased LDL-C clearance and reduced plasma levels of LDL-C. 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 and
the fixed-dose combination of bempedoic acid and ezetimibe, the
design and timing of the announcement of top-line results from
ETC-1002-040, the Company’s plans regarding its Phase 3 program and
the planned cardiovascular outcomes trial. 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 patient enrollment in the Company’s studies, the risk that FDA
may require additional studies or data, including prior to approval
that might cause approval to be delayed, that Esperion may need to
change the design of its Phase 3 program, including upon feedback
from regulatory authorities, that positive results from a clinical
study of bempedoic acid and the fixed-dose combination of bempedoic
acid and ezetimibe may not necessarily be predictive of the results
of future clinical studies, particularly in different or larger
patient populations, or in all statin doses, including high doses,
or the risk that other unanticipated developments or data could
interfere with the scope of development and commercialization of
bempedoic acid and the fixed-dose combination of bempedoic acid and
ezetimibe, as well as other risks detailed in Esperion’s filings
with the Securities and Exchange Commission, including our Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q. 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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