Esperion Therapeutics Announces Initiation of Phase 2 Clinical Study of Bempedoic Acid in Patients Treated With High-Dose Sta...
January 12 2016 - 4:05PM
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 initiation of its Phase 2
pharmacokinetics/pharmacodynamics (PK/PD) study (ETC-1002-035) of
bempedoic acid in patients treated with atorvastatin 80 mg, the
most commonly prescribed high-dose statin. The Company expects to
announce top-line results from the study by mid-year.
"Bempedoic acid has significant potential to be
a new therapeutic option, not only for patients who are unable to
tolerate statin therapy, but also as an ‘add-on’ for those patients
already taking a statin who need additional LDL-C lowering,” said
Tim M. Mayleben, president and chief executive officer of Esperion.
“We expect completion of this study will demonstrate incremental
efficacy when added to a high-dose statin, which is important to
extend the clinical profile of bempedoic acid and market potential
in patients who are not adequately treated with maximum statin
therapy.”
ETC-1002-035 is a Phase 2 randomized,
double-blind, parallel group study evaluating 60 patients on stable
atorvastatin 80 mg per day. All patients in the study will receive
80 mg of atorvastatin for four weeks. Patients will then be
randomized to receive either 180 mg of bempedoic acid, or placebo,
for four weeks. The study will enroll patients at approximately 20
centers across the U.S. The primary objectives of the study are to
assess the LDL-C lowering efficacy of bempedoic acid versus placebo
on a background of atorvastatin 80 mg, as well as multiple-dose
plasma PK of atorvastatin 80 mg alone and in combination with
bempedoic acid. Secondary objectives include assessing the effect
of bempedoic acid on lipid and cardiometabolic biomarkers,
including high-sensitivity C-reactive protein; characterizing the
tolerability and safety of bempedoic acid; and evaluating the
steady-state plasma PK of bempedoic acid.
Next month, the Company also intends to initiate
a Phase 1 clinical pharmacology study of bempedoic acid
(ETC-1002-037), which will be an open label, drug-drug interaction
study to assess the safety and tolerability of bempedoic acid at
steady-state, as well as the PK of single doses of the
highest-doses of the most commonly prescribed statins: atorvastatin
80 mg, rosuvastatin 40 mg, simvastatin 40 mg, and pravastatin 80
mg. The Company expects to announce top-line results from the study
by mid-year.
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-1002-035, and the design, timing of the initiation and read-out
of top-line results of the Company’s Phase 1 drug-drug interaction
study. 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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