- Global Pivotal Phase 3 Program Design Can
Support Approval for an LDL-C Lowering Indication - - Proposed
LDL-C Lowering Indication Will Include Patients with High CVD Risk,
Specifically Those with ASCVD and/or HeFH - - On Track to
Submit NDA for an LDL-C Lowering Indication by 1H 2019 - -
Conference Call and Webcast on Monday, March 20, 2017 at 8:00 a.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 that Esperion’s LDL-C
lowering program is adequate to support approval of an LDL-C
lowering indication for bempedoic acid.
Esperion plans to submit a new drug application
(NDA) by 1H 2019 for an LDL-C lowering indication based on the
successful completion of the global pivotal Phase 3 program. The
proposed product label would include specific language for use of
bempedoic acid as an adjunct to maximally tolerated statin therapy
in patients with hypercholesterolemia, specifically those at high
cardiovascular disease (CVD) risk with atherosclerotic
cardiovascular disease (ASCVD) and/or heterozygous familial
hypercholesterolemia (HeFH) who require additional LDL-C
lowering.
"We are very pleased to have achieved clarity
from FDA regarding Esperion’s LDL-C lowering development program,"
said Tim M. Mayleben, president and chief executive officer of
Esperion. "Our experienced lipid management team has worked closely
with regulatory authorities and our key advisors to achieve this
encouraging outcome. We continue to believe that bempedoic acid has
the potential to provide physicians with a complementary and
convenient oral treatment option that’s cost-effective for their
patients with hypercholesterolemia who require additional LDL-C
lowering. We remain focused on completing the global pivotal Phase
3 program for bempedoic acid and reporting top-line results from
our long-term safety and tolerability study by Q2 2018 and top-line
results from our ongoing Phase 3 LDL-C lowering efficacy studies by
mid-2018."
Interactions with FDA also addressed the ongoing
cardiovascular outcomes trial (CVOT), Cholesterol
Lowering via BEmpedoic Acid, an
ACL-inhibiting Regimen (CLEAR)
Outcomes for bempedoic acid in patients with or at high risk for
CVD who are only able to tolerate less than the lowest approved
daily starting dose of a statin and are considered statin
intolerant. For purposes of the CVOT, agreement has been reached
with FDA that the following definition of statin intolerance is
acceptable for the CVOT: “the inability to tolerate two or more
statins, one at the lowest approved daily starting dose, due to an
adverse effect,” as defined in CLEAR Outcomes. The lowest approved
daily starting statin doses include an average daily dose of <5
mg rosuvastatin, <10 mg of atorvastatin, <10 mg simvastatin,
<20 mg lovastatin, <40 mg pravastatin, <40 mg fluvastatin
and <2 mg of pitavastatin. In CLEAR Outcomes, patients and
investigators will provide written confirmation that the patient is
statin intolerant and that the patient is aware of the benefits of
statins in reducing the risk of cardiovascular events and death.
The Company expects to submit an NDA for a cardiovascular disease
risk reduction indication to the FDA and a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) by 2022,
upon successful completion of CLEAR Outcomes.
Global Pivotal Phase 3
Program
The Phase 3 clinical development program
initiated in January 2016 with a global pivotal 52-week long-term
safety and tolerability study (Study 1) in 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. Patient enrollment of more than 2,200
patients was completed in January 2017 and top-line results from
this study are expected by Q2 2018. An open-label extension study
(1002-050) of Study 1 was initiated in February 2017 to collect
additional patient safety data.
Three additional global pivotal Phase 3 LDL-C
lowering efficacy studies initiated in December 2016 and are
currently enrolling patients at high CVD risk with
hypercholesterolemia who are inadequately treated with current
lipid-modifying therapies and require additional LDL-C
lowering:
- Study 2: patients with ASCVD and/or HeFH who have LDL-C levels
of ≥100 mg/dL;
- Study 3: 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;
- Study 4: patients on low dose or less than low dose of their
statin who are taking ezetimibe who have LDL-C levels of ≥100
mg/dL.
The overall global pivotal Phase 3 program is
expected to enroll approximately 3,200 patients at high CVD risk
with hypercholesterolemia on optimized background lipid-modifying
therapy. Top-line results from our long-term safety and
tolerability study are expected by Q2 2018 with top-line results
from the three LDL-C lowering efficacy studies expected by
mid-2018. Submissions of an NDA to the FDA and a MAA to the EMA for
an LDL-C lowering indication are expected by 1H 2019.
CLEAR Outcomes CVOT
The CLEAR Outcomes CVOT, initiated in the fourth
quarter of 2016, is expected to enroll approximately 12,600
patients with hypercholesterolemia and high CVD risk at more than
600 sites in approximately 30 countries. Patients enrolling in the
study will be required to have a history of, or be at high-risk
for, CVD with LDL-C levels between 100 mg/dL and 190 mg/dL despite
background lipid-lowering therapy, resulting in an expected average
baseline LDL-C level in all patients of approximately 135 mg/dL.
The CVOT is currently enrolling patients, expected to enroll over a
30-month period and on track to be well-underway by 1H 2019, when
we expect to submit our LDL-C lowering indication global regulatory
submissions.
The Company expects to submit an NDA for
cardiovascular disease risk reduction to the FDA and a MAA to EMA
by 2022, upon the successful completion of CLEAR Outcomes.
Conference Call and Webcast
Information
Esperion's lipid management team 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 81741000. 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. 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 approximately 90 days.
About Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, orally available, once-daily ACL
inhibitor that has been shown to reduce cholesterol biosynthesis
and lower elevated levels of LDL-C by up-regulating the LDL
receptor, but may potentially reduce the occurrence of
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
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 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 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 CVD; the leading cause of death around the world. Bempedoic
acid, the Company's lead product candidate, is a targeted therapy
that has 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 bempedoic acid, 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 long-term safety and
tolerability program for bempedoic acid. Any express or implied
statements contained in this press release that are not statements
of historical fact, including interpretation of guidance given by
the FDA, 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, changes in the FDA
guidance for regulatory approval, delays or failures in the
Company’s studies, including risks regarding the FDA’s
interpretation of the Company’s clinical trial results, the risk
that U.S. Food and Drug Administration may require additional
studies or data, that Esperion may need to change the design of its
Phase 3 program, that positive results from a clinical study of
bempedoic acid may not be sufficient for FDA approval or
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, that Esperion’s global Phase 3 long-term safety and
tolerability program for bempedoic acid may not produce sufficient
safety or tolerability results or show meaningful change in LDL-C
or other key lipid measures of patients, if approved that
Esperion’s product could have labeling restrictions that impact its
marketing and adoption, 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. The
FDA guidance described in this release was given as of a specific
date and the FDA could change its position on the clinical
endpoints or other standards for review/approval. You are cautioned
not to place undue reliance on the forward-looking statements,
which speak only as of the date of this release. Actual results
could differ from those described therein. 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
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Apr 2023 to Apr 2024