– Complementary, Non-statin, Oral Bempedoic Acid
/ Ezetimibe Combination Therapy Demonstrates 48% Lowering of LDL-C
and Significant hsCRP Reduction with Potential for Lower Occurrence
of Muscle-Related Side Effects –– Bempedoic Acid / Ezetimibe
Combination Program to be Conducted Concurrently with Ongoing
Global Pivotal Phase 3 Program for Bempedoic Acid –– Phase 3
Bempedoic Acid / Ezetimibe Combination Bridging Study to Initiate
by Fourth Quarter of 2017 –– On Track to Submit Both the Bempedoic
Acid / Ezetimibe Combination and Bempedoic Acid Global Regulatory
Filings for an LDL-C Lowering Indication by First Half of 2019 ––
Conference Call and Webcast on Monday, June 26, 2017 at 4:30 p.m.
Eastern Time –
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 U.S. Food and Drug
Administration (FDA) recently confirmed the regulatory pathway to
approval for the once-daily, oral combination pill of bempedoic
acid 180 mg and ezetimibe 10 mg.
Based on feedback received from the FDA,
Esperion plans to initiate a single global pivotal Phase 3 bridging
study (1002FDC-053) for the bempedoic acid / ezetimibe combination
pill that will be conducted concurrently with the ongoing global
pivotal Phase 3 program for bempedoic acid. The Phase 3 bridging
study will support approval for an LDL-C lowering indication in
both the U.S. and Europe. The randomized, double-blind,
placebo-controlled study is expected to enroll up to 350 patients
with hypercholesterolemia and with atherosclerotic cardiovascular
disease (ASCVD) and/or heterozygous familial hypercholesterolemia
(HeFH), including high cardiovascular risk primary prevention
patients, whose LDL-C is not adequately controlled. The goal of
this study is to evaluate the efficacy and safety of the bempedoic
acid / ezetimibe combination, a convenient, cost-effective,
once-daily, oral pill. Additional design details for this study
will be provided upon initiation by the fourth quarter of 2017,
with top-line results expected by the end of 2018.
In tandem with the NDA submission for bempedoic
acid, the company plans to submit a New Drug Application (NDA) for
an LDL-C lowering indication for the bempedoic acid / ezetimibe
combination through the available abbreviated 505(b)(2) pathway by
the first half of 2019. The company also expects to submit a
Marketing Authorization Application (MAA) for an LDL-C lowering
indication for the bempedoic acid / ezetimibe combination,
consistent with the European Medicines Agency’s “Guideline on
Clinical Development of Fixed Combination Medicinal Products,” in
tandem with the MAA submission for bempedoic acid by the first half
of 2019.
“Esperion now has two convenient,
cost-effective, complementary, non-statin, once-daily, oral LDL-C
lowering therapies in Phase 3 development both with confirmed
regulatory pathways to approval and defined clinical development
programs. The complementary mechanisms of action of bempedoic acid
and ezetimibe provide a nearly 50 percent reduction in LDL-C
lowering and this exciting therapy could become our most important
therapy with the potential to address the LDL-C lowering needs of
far more patients than bempedoic acid alone,” said Tim M. Mayleben,
president and chief executive officer of Esperion. “We expect that
these two distinct oral, non-statin LDL-C lowering therapies will
complement existing standard of care oral therapies and provide
patients, physicians and payers with much-needed options to
conveniently and cost-effectively lower elevated LDL-C in patients
who require additional LDL-C lowering. We look forward to
initiating the bempedoic acid / ezetimibe combination clinical
program, reporting top-line results and, most importantly,
achieving the tandem global regulatory submissions for LDL-C
lowering indications for both the bempedoic acid / ezetimibe
combination and bempedoic acid by the first half of 2019.”
Conference Call and Webcast Information
Esperion's lipid management team will host a
conference call and webcast to discuss these updates. The call can
be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184
(international) five minutes prior to the start of the call and
providing access code 40325639. A live audio webcast can be
accessed on the investors and media section of the Esperion website
at investor.esperion.com. Access to the webcast replay will be
available approximately two hours after completion of the call and
will be archived on the Company's website for approximately 90
days.
Combination of Bempedoic Acid and Ezetimibe
Through the complementary mechanisms of action
of inhibition of cholesterol synthesis (bempedoic acid) and
inhibition of cholesterol absorption (ezetimibe), the bempedoic
acid / ezetimibe combination is our lead, non-statin, orally
available, once-daily, LDL-C lowering therapy. Inhibition of ATP
Citrate Lyase (ACL) by bempedoic acid reduces cholesterol
biosynthesis and lowers LDL-C by up-regulating the LDL receptor.
Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results
in reduced absorption of cholesterol from the gastrointestinal
tract, thereby reducing delivery of cholesterol to the liver, which
in turn upregulates LDL receptors. Previously completed Phase 2
data demonstrated that this safe and well tolerated combination
results in a 48 percent lowering of LDL-C, a 26 percent reduction
in high sensitivity C-reactive protein (hsCRP), and may potentially
be associated with a lower occurrence of muscle-related side
effects.
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
regulatory approval pathway for the bempedoic acid / ezetimibe
combination and bempedoic acid and the therapeutic potential of,
and clinical development plan for, the bempedoic acid / ezetimibe
combination and 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, 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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