Esperion Announces Initiation of Phase 2 Study of Bempedoic Acid Added-On to a PCSK9 Inhibitor
July 26 2017 - 4:30PM
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 (1002-039) to assess the efficacy and safety of
bempedoic acid when added-on to an injectable proprotein convertase
subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. This
non-registrational study will assess the incremental LDL-C lowering
efficacy and continued safety and tolerability of a once-daily,
oral bempedoic acid pill added-on to an injectable biologic therapy
in patients with elevated LDL-C levels. Top-line results are
expected by the first quarter of 2018.
The eight-week, Phase 2, randomized,
double-blind, placebo-controlled study will evaluate the efficacy
and safety of once-daily, oral bempedoic acid 180 mg and
once-monthly injection of Repatha® (evolocumab) 420 mg versus
placebo. The study is expected to enroll approximately 50 patients
with hypercholesterolemia at approximately 20 sites across the U.S.
The primary objective of the study is to assess the incremental
LDL-C lowering efficacy of bempedoic acid versus placebo in
patients receiving PCSK9i therapy. Secondary objectives include
assessing the safety and tolerability of bempedoic acid versus
placebo in patients on PCSK9i therapy 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).
“From our recent market research it’s clear
there remains a strong preference among patients, physicians and
payers for convenient, cost-effective, once-daily, oral LDL-C
lowering therapies that can be used with currently available
therapies," said Tim M. Mayleben, president and chief executive
officer of Esperion. “It is important to note that we don’t intend
to explore bempedoic acid added-on to a PCSK9i in further studies
due to their limited use to date. In this Phase 2 study, we
anticipate that we will see the favorable safety, tolerability and
incremental LDL-C lowering efficacy that we have come to expect
from bempedoic acid.”
Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, complementary, orally available,
once-daily ACL inhibitor that reduces cholesterol biosynthesis and
lowers LDL-C by up-regulating the LDL receptor, and may potentially
be associated with a lower occurrence of muscle-related side
effects. Completed Phase 1 and 2 studies conducted in more than
1,000 patients and over 800 patients treated with bempedoic acid
have produced clinically relevant LDL-C lowering results of up to
30 percent as monotherapy 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 are therefore considered to
be statin intolerant. Esperion-discovered and developed, bempedoic
acid is a targeted LDL-C lowering therapy in Phase 3 development.
The company has two convenient, cost-effective, complementary,
orally available, LDL-C lowering therapies in Phase 3 development:
1) a once-daily, oral bempedoic acid / ezetimibe combination pill,
and 2) bempedoic acid, a once-daily, oral pill.
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 cardiovascular disease; the leading cause of death around
the world. Bempedoic acid and the company's lead product candidate,
the bempedoic acid / ezetimibe combination, are targeted therapies
that have been shown to significantly reduce 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, the
bempedoic acid / ezetimibe combination and bempedoic acid,
including the company’s timing, designs, plans and announcement of
results from the 1002-039 Phase 2 clinical study and the
therapeutic potential of bempedoic acid when added to injectable
PCSK9i therapy. 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,
that existing cash resources may be used more quickly than
anticipated, that the 1002-039 Phase 2 clinical study may not
produce sufficient safety and tolerability results or show
meaningful change in LDL-C or other efficacy measures, 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. 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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