Global Phase 3 Program Top-Line Results Expected
Mid-2018
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 three remaining global pivotal Phase 3 LDL-C
lowering efficacy studies of bempedoic acid in atherosclerotic
cardiovascular disease (ASCVD), heterozygous familial
hypercholesterolemia (HeFH) and patients considered “statin
intolerant” with hypercholesterolemia who are inadequately treated
with current lipid-modifying therapies.
“We are pleased our three global pivotal Phase 3 efficacy
studies are now actively enrolling. With the global pivotal Phase 3
long-term safety study now nearly fully-enrolled, we remain on
track to deliver top-line results from all of our pivotal studies
in the Phase 3 program by mid-2018,” said Tim. M. Mayleben,
president and chief executive officer of Esperion. “With Dr.
Christie Ballantyne as chairman of our Phase 3 Executive Committee,
the global Phase 3 clinical development program has been rigorously
designed to support a LDL-C lowering label as an adjunct to diet
and maximally tolerated statin therapy in high cardiovascular
disease (CVD) risk patients in the U.S., with the European label
expected to include specific language regarding the use of
bempedoic acid in patients who are considered ‘statin intolerant’.
We believe that bempedoic acid has high potential to provide a new,
complementary, oral, once-daily LDL-C lowering therapy that could
transform the lives of high CVD risk patients with
hypercholesterolemia.”
Global Pivotal Phase 3 LDL-C Lowering
Program
The global Phase 3 clinical development program initiated in
January 2016 with a global pivotal 52-week long-term safety
study.
The Company today announced the initiation of the three
remaining global pivotal LDL-C lowering efficacy studies. The
overall Phase 3 program – including the ongoing long-term safety
study and the three LDL-C lowering efficacy studies in high CVD
risk patients (ASCVD, HeFH and “statin intolerant”) – is designed
to enroll over 3,200 high CVD risk patients with
hypercholesterolemia on optimized background lipid-modifying
therapy, specifically patients with ASCVD and/or HeFH who have
LDL-C levels of ≥100 mg/dL; and patients who are only able to
tolerate less than the lowest approved daily starting dose of their
statin and considered "statin intolerant" who have LDL-C levels of
≥100 mg/dL. Global regulatory submissions for an LDL-C lowering
indication are expected by the first half of 2019 for a New Drug
Application to the U.S. Food and Drug Administration (FDA) and a
Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA).
Top-line results from the global Phase 3 program in its entirety
are expected by mid-2018.
Global Pivotal Phase 3 Study 1 (1950 ASCVD and/or HeFH
patients): 52-week global pivotal Phase 3 randomized,
double-blind, placebo-controlled study evaluating the long-term
safety of 180 mg of bempedoic acid versus placebo – initiated in
January 2016 – is expected to enroll approximately 1,950 patients
with hypercholesterolemia (with ASCVD and/or HeFH) at high CVD risk
and whose LDL-C is not adequately controlled with current
lipid-modifying therapies. Additional safety data will be obtained
from an open-label extension study initiating later this month.
Global Pivotal Phase 3 Study 2 (750 ASCVD and/or HeFH
patients): 52-week global pivotal Phase 3 randomized,
double-blind, placebo-controlled study evaluating the safety and
efficacy of 180 mg of bempedoic acid versus placebo. This study is
expected to enroll 750 patients with hypercholesterolemia (with
ASCVD and/or HeFH) at high CVD risk and whose LDL-C is not
adequately controlled with current lipid-modifying therapies. The
study will be conducted at approximately 125 sites in the U.S.,
Canada and Europe. The primary objective is to assess the 12-week
LDL-C lowering efficacy of patients treated with bempedoic acid
versus placebo. Secondary objectives include evaluating the 24-week
LDL-C lowering efficacy, and 52-week safety and tolerability of
bempedoic acid versus placebo. 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), will also be evaluated.
Global Pivotal Phase 3 Study 3 (300 patients considered
“statin intolerant”): 24-week global pivotal Phase 3
randomized, double-blind, placebo-controlled study evaluating the
safety and efficacy of 180 mg of bempedoic acid versus placebo.
This study is expected to enroll 300 patients with
hypercholesterolemia on optimized background lipid-modifying
therapy, including patients considered "statin intolerant." The
study will be conducted at approximately 70 sites in the U.S. and
Canada. The primary objective is to assess the 12-week LDL-C
lowering efficacy of patients treated with bempedoic acid versus
placebo. Secondary objectives include evaluating the 24-week LDL-C
lowering efficacy, safety and tolerability of bempedoic acid versus
placebo and effects on other risk markers, including non-HDL-C,
total cholesterol, apoB and hsCRP.
Global Pivotal Phase 3 Study 4 (225 patients considered
“statin intolerant”): 12-week global pivotal Phase 3
randomized, double-blind, placebo-controlled study evaluating the
safety and efficacy of 180 mg of bempedoic acid versus placebo as
an add-on to 10 mg of ezetimibe. This study is expected to enroll
225 patients with hypercholesterolemia on optimized background
lipid-modifying therapy, including ezetimibe, and patients
considered "statin intolerant." The study will be conducted at
approximately 75 sites in the U.S., Canada and Europe. The primary
objective is to assess the 12-week LDL-C lowering efficacy of
patients treated with bempedoic acid versus placebo when added to
ezetimibe. Secondary objectives include evaluating safety and
tolerability of bempedoic acid when added to ezetimibe, and effects
on other risk markers, including non-HDL-C, total cholesterol, apoB
and hsCRP.
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, in each case including that
submissions for an LDL-C lowering indication could be filed in the
United States and Europe prior to the completion of a
cardiovascular outcomes trial, or CVOT. 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, the impact of
future changes in FDA’s view of LDL-C lowering as a surrogate
endpoint or standard-of-care treatment for patients with elevated
LDL-C levels, 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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