1002-035 Study Meets Primary Endpoint of
Incremental LDL-C Lowering Added to Atorvastatin 80 mgBempedoic
Acid Had No Effect on the PK of Atorvastatin and Was Observed to be
Safe and Well-Tolerated Conference Call and Webcast on October
13, 2016 at 8:00 a.m. Eastern Time
Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company
focused on developing and commercializing oral therapies for the
treatment of patients with elevated low density lipoprotein
cholesterol (LDL-C), today announced the bempedoic acid global
pivotal Phase 3 LDL-C lowering clinical development program will
include patients with hypercholesterolemia on any statin at any
dose based on positive top-line results from its Phase 2
pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic
acid added to atorvastatin 80 mg (1002-035), and the previously
completed Phase 1 and Phase 2 studies.
Top-line results from 1002-035 demonstrated the eight-week study
met its primary endpoint of greater LDL-C lowering from baseline of
22 percent (p=0.0028) with bempedoic acid 180 mg compared with
placebo with all patients on a background of atorvastatin 80 mg.
Bempedoic acid also demonstrated an incremental reduction of 35
percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP),
an important marker of the underlying inflammation associated with
cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg
produced no clinically relevant effects on atorvastatin PK, and
appeared to be safe and well-tolerated, with no serious adverse
events reported.
“With the positive clinical results of bempedoic acid added to
high-dose statins, and following engagement with global regulatory
agencies, we are pleased to include in our ongoing global Phase 3
program patients with elevated LDL-C levels inadequately treated
with current lipid-modifying therapies, including patients on any
statin at any dose,” said Tim Mayleben, president and chief
executive officer of Esperion Therapeutics. “Bempedoic acid has
demonstrated consistent LDL-C lowering efficacy, safety, and
tolerability in completed Phase 1 and Phase 2 studies, including
most recently in combination with high-dose statins. We believe
that bempedoic acid is well-positioned as a once-daily, oral
therapy for patients with hypercholesterolemia taking maximally
tolerated statin therapy and/or ezetimibe who require additional
LDL-C lowering, including patients considered 'statin intolerant'.
We remain keenly focused on initiating both the bempedoic acid
global Phase 3 efficacy program and our cardiovascular outcomes
study before year-end.”
Global Pivotal Phase 3 CLEAR LDL-C Lowering
Program
Prior to year-end, Esperion plans to initiate three global
pivotal Phase 3 Cholesterol Lowering via BEmpedoic Acid,
an ACL-inhibiting Regimen (CLEAR) LDL-C lowering efficacy
studies – 1002-046, 1002-047, and 1002-048 – in patients with
hypercholesterolemia who are inadequately treated with current
lipid-modifying therapies.
The LDL-C lowering studies will include patients on optimized
background lipid-modifying therapy, including maximally tolerated
statin therapy, with LDL-C levels of ≥130 mg/dL for patients
without atherosclerotic cardiovascular disease (ASCVD) and ≥100
mg/dL for patients with ASCVD and/or heterozygous familial
hypercholesterolemia (HeFH). The CLEAR LDL-C lowering efficacy
studies are designed to measure the change in LDL-C from baseline
at 12 weeks. Top-line results from the global pivotal Phase 3 CLEAR
LDL-C lowering program are anticipated in mid-2018. Submissions are
expected in the first half of 2019 for a New Drug Application to
the U.S. Food and Drug Administration (FDA) and a Marketing
Authorization Application to the European Medicines Agency (EMA)
for an LDL-C lowering indication.
The proposed high-level global Phase 3 design details are
included below, as well as updates to the design of the ongoing
CLEAR Harmony long-term safety study. Additional design details for
1002-046, 1002-047, and 1002-048 will be made available when the
studies initiate later this quarter.
- 1002-046: 24-week study to assess the 12-week
LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus
placebo in hypercholesterolemic patients (with or without ASCVD)
not adequately treated with current lipid-modifying therapies. This
study is designed to enroll 300 patients only able to tolerate less
than the lowest approved daily starting dose of a statin and can be
considered “statin intolerant.” This study is expected to initiate
before year-end.
- 1002-047: 52-week study to assess the 12-week
LDL-C efficacy primary endpoint of bempedoic acid 180 mg versus
placebo in hypercholesterolemic patients (with ASCVD and/or HeFH)
not adequately treated with current lipid-modifying therapies. This
study is designed to enroll approximately 750 patients and is
expected to initiate before year-end.
- 1002-048: 12-week study to assess the LDL-C
efficacy primary endpoint of bempedoic acid 180 mg versus placebo
in hypercholesterolemic patients (with or without ASCVD) when added
to ezetimibe. This study is designed to enroll approximately 225
patients and is also expected to initiate before
year-end.
- CLEAR Harmony (1002-040): Initiated in January
2016, CLEAR Harmony is a 52-week, long-term safety study designed
to enroll hypercholesterolemic patients (with ASCVD and/or HeFH)
who are not adequately treated with current lipid-modifying
therapies. At initiation, this study included 900 patients, but has
been expanded to 1,950 patients to further support the Company’s
expected first half 2019 regulatory submission for an LDL-C
lowering indication. As a result of the expanded enrollment,
top-line results for CLEAR Harmony are now expected by
mid-2018.
The global Phase 3 LDL-C lowering efficacy studies are designed
to support a broad label for the use of bempedoic acid for LDL-C
lowering in hypercholesterolemic patients (> 100 mg/dL) who are
inadequately treated with current lipid-modifying therapies. In
Europe, it is expected that there would be specific language
included within the label for the use of bempedoic acid in patients
who are considered “statin intolerant.”
Phase 2 (1002-035) and Phase 1 (1002-037) Clinical
Results Summary
The Phase 2 PK/PD eight-week, U.S.-based, multi-center,
randomized, double-blind, parallel group clinical study (1002-035)
evaluated 68 patients on stable atorvastatin 80 mg per day. All
patients in the study received atorvastatin 80 mg for four weeks.
Patients were then randomized to receive either bempedoic acid 180
mg, or placebo, for four weeks. The primary objectives of the study
were 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 included
assessment of the effect of bempedoic acid on lipid and
cardiometabolic biomarkers, including hsCRP; and characterization
of the tolerability and safety of bempedoic acid.
Top-line results from 1002-035 demonstrated the eight-week study
met its primary endpoint of greater LDL-C lowering of 22 percent
(p=0.0028) from baseline with bempedoic acid 180 mg compared with
placebo with all patients on a background of atorvastatin 80 mg.
There was a 13 percent reduction in LDL-C in the bempedoic acid
group and a nine percent increase in LDL-C in the placebo group
when added to background atorvastatin 80 mg. Bempedoic acid also
demonstrated an incremental reduction of 35 percent (p=0.0020) in
high-sensitivity C-reactive protein (hsCRP), an important marker of
the underlying inflammation associated with cardiovascular disease.
Bempedoic acid added to atorvastatin 80 mg produced no clinically
relevant effects on atorvastatin PK, and appeared to be safe and
well-tolerated, with no serious adverse events reported.
The Company also announced positive top-line results from its
Phase 1, open-label, clinical pharmacology study (1002-037) to
assess the PK levels in healthy volunteers receiving 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 – when added to steady-state bempedoic acid 180
mg. The PK profiles demonstrated in 1002-037 were consistent
with those seen in previous studies conducted with bempedoic acid,
and did not increase with the highest doses of the statins tested
in combination with bempedoic acid. Together, with the results of
1002-035, these data support enrollment of patients with
hypercholesterolemia on any statin at any dose in the global
pivotal Phase 3 CLEAR LDL-C clinical development program.
Conference Call and Webcast Details
Esperion's management will host a conference call to discuss
these updates. The call can be accessed by dialing (877) 831-3840
(domestic) or (253) 237-1184 (international) five minutes prior to
the start of the call and providing access code 98706260. A live,
listen-only webcast of the conference call can be accessed on the
investor relations section of the Esperion website at
investor.esperion.com, along with slides to accompany this update.
A webcast replay of the call will be available approximately two
hours after completion of the call and will be archived on the
Company's website for two weeks.
About Bempedoic Acid
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. Phase 1 and 2 studies conducted
previously 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 to 22 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 is to provide patients and
physicians with a new oral therapy to significantly reduce elevated
levels of LDL-C in patients inadequately treated with current
lipid-modifying therapies. Esperion-discovered and developed,
bempedoic acid is an oral LDL-C lowering therapy in Phase 3
development. The Company plans to develop bempedoic acid as a
monotherapy as well as a fixed dose combination (FDC) with
ezetimibe, with a particular focus on patients inadequately treated
with current lipid-modifying therapies. It is estimated that
approximately 5-20 percent of patients who are prescribed statins
are only able to tolerate less than the lowest approved daily
starting dose of their statin (“statin intolerant”).
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a pharmaceutical company
focused on developing and commercializing oral therapies for the
treatment of patients with elevated LDL-C. Through scientific and
clinical excellence, and a deep understanding of cholesterol
biology, the 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, the Company’s lead product candidate,
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,
as well as other risks detailed in Esperion’s filings with the
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the year ended December 31, 2015 and subsequently
filed 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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