Esperion (NASDAQ:ESPR), today announced that the final Phase 3
results from Study 3 (1002-046, also known as CLEAR Serenity) were
presented at the American Heart Association (AHA) Scientific
Sessions in Chicago. The late-breaking oral presentation was
delivered by Professor Dr. med Ulrich Laufs, Director of the
Department of Cardiology at Leipzig University, Leipzig, Germany.
This study evaluated the LDL-C lowering efficacy and the safety and
tolerability of bempedoic acid 180 mg versus placebo in high-risk
patients with atherosclerotic cardiovascular disease (ASCVD), or at
high risk for ASCVD with hypercholesterolemia, inadequately treated
with maximally tolerated background LDL-C lowering therapy who are
only able to tolerate less than the approved daily starting dose of
a statin and considered statin intolerant. Topline results were
previously announced in May 2018.
Details on the presentations are as follows:Title: Efficacy and
Safety of Bempedoic Acid in Patients With Hypercholesterolemia and
Statin IntoleranceDate: November 10, 2018 Time: 8:15 a.m. ET
Location: McCormick Place Convention Center
“In Esperion’s CLEAR Serenity trial, bempedoic acid was shown to
significantly lower both LDL-cholesterol and high-sensitivity
C-reactive protein (hsCRP) in statin-intolerant patients.
There is a significant need for additional treatments for the large
number of patients with hypercholesterolemia who are not at their
LDL-cholesterol treatment goals despite using maximally tolerated
statins. This is particularly true for patients who cannot
tolerate statins and have limited options available,” said
Professor Laufs.
Design of Global Pivotal Phase 3 Study 3 (1002-046, also
known as CLEAR Serenity)
The 24-week, global pivotal Phase 3 randomized, double-blind,
placebo-controlled, multicenter study evaluated the LDL-C lowering
efficacy and safety of bempedoic acid 180 mg/day versus placebo
added to background lipid-modifying therapy in patients with
hypercholesterolemia who are considered statin intolerant. The
study was conducted at 67 sites in the U.S. and Canada. A total of
345 patients were randomized 2:1 to receive bempedoic acid or
placebo. The primary efficacy objective was to assess the 12-week
LDL-C lowering efficacy of bempedoic acid versus placebo. Secondary
objectives included evaluating the 24-week LDL-C lowering efficacy
of bempedoic acid versus placebo, the safety and tolerability of
bempedoic acid versus placebo, and its effects on other risk
markers after 12 weeks of treatment, including hsCRP.
About Esperion's Global Pivotal Phase 3 LDL-C Lowering
Program
Esperion initiated its global, pivotal, Phase 3 clinical
development program – known as Cholesterol
Lowering via BEmpedoic Acid, an
ACL-inhibiting Regimen (CLEAR) –
in January 2016 to evaluate the safety, tolerability and
consistent, complementary LDL-C-lowering efficacy of bempedoic acid
and the bempedoic acid / ezetimibe combination pill. Patients
evaluated had atherosclerotic cardiovascular disease (ASCVD), or
were at a high risk for ASCVD, with hypercholesterolemia who
continue to have elevated levels of LDL-C despite the use of
maximally-tolerated statins and ezetimibe, leaving them at high
risk for cardiovascular events. The Phase 3 LDL-C lowering
development program includes five studies in approximately 4,000
patients, four for bempedoic acid and one for the bempedoic acid /
ezetimibe combination pill.
- Two pivotal studies evaluating bempedoic acid – Study 1 (CLEAR
Harmony) & Study 2 (CLEAR Wisdom) – in 3,008 patients with
ASCVD on maximally-tolerated statins, with top-line results
reported in May 2018 and October 2018, respectively;
- Two pivotal studies evaluating bempedoic acid – Study 3 (CLEAR
Serenity) & Study 4 (CLEAR Tranquility) – in 613 patients with
ASCVD, or at a high risk for ASCVD, considered statin intolerant,
with top-line results reported in May 2018 and March 2018,
respectively;
- One pivotal study evaluating the bempedoic acid / ezetimibe
combination pill (053 Study) in 382 patients with ASCVD, or at high
risk for ASCVD, on maximally tolerated statins, with top-line
results reported in August 2018.
Esperion plans to submit New Drug Applications (NDAs) to the
U.S. Food and Drug Administration (FDA) for bempedoic acid and the
bempedoic acid / ezetimibe combination pill for LDL-C lowering
indications during the first quarter of 2019. Additionally,
Esperion plans to submit Marketing Authorization Applications
(MAAs) to the European Medicines Agency (EMA) during the second
quarter of 2019.
Bempedoic Acid / Ezetimibe Combination Pill
Through the complementary mechanisms of action of inhibition of
cholesterol synthesis (bempedoic acid) and inhibition of
cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe
combination pill 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 the
LDL receptors. Phase 3 data demonstrated that this safe and
well tolerated combination results in a 35 percent lowering of
LDL-C when used with maximally tolerated statins, a 43 percent
lowering of LDL-C when used as a monotherapy, and a 34 percent
reduction in high sensitivity C-reactive protein (hsCRP).
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is a
first-in-class, complementary, orally available, once-daily ATP
Citrate Lyase (ACL) inhibitor that, reduces cholesterol
biosynthesis and lowers LDL-C by up-regulating the LDL receptor.
Similar to statins, bempedoic acid also reduces hsCRP, a key marker
of inflammation associated with cardiovascular disease. Completed
Phase 2 and Phase 3 studies conducted in almost 4,800 patients, and
approximately 3,100 patients treated with bempedoic acid, have
produced an additional 20 percent LDL-C lowering when used with
maximally tolerated statins, up to 30 percent LDL-C lowering as
monotherapy, 35 percent LDL-C lowering in combination with
ezetimibe when used with maximally tolerated statins, and up to 48
percent LDL-C lowering in combination with ezetimibe as
monotherapy.
The effect of bempedoic acid on cardiovascular morbidity and
mortality has not yet been determined. The company initiated a
global cardiovascular outcomes trial (CVOT) to assess the effects
of bempedoic acid on the occurrence of major cardiovascular events
in patients with, or at high risk for, cardiovascular disease (CVD)
who are only able to tolerate less than the lowest approved daily
starting dose of a statin and considered "statin intolerant." The
CVOT — known as CLEAR Outcomes — is an event-driven, global,
randomized, double-blind, placebo-controlled study expected to
enroll approximately 12,600 patients with hypercholesterolemia and
high CVD risk at over 1,000 sites in approximately 30
countries.
Esperion's Commitment to Patients with
Hypercholesterolemia
High levels of LDL-C can lead to a build-up of fat and
cholesterol in and on artery walls (known as atherosclerosis),
potentially leading to cardiovascular events, including heart
attack or stroke. In the U.S., 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. There are
approximately 13 million people in the U.S. with atherosclerotic
cardiovascular disease (ASCVD) who live with elevated levels of
LDL-C despite taking maximally-tolerated lipid-modifying therapy —
including individuals considered statin intolerant — leaving them
at high risk for cardiovascular events. More than 6 million
patients with ASCVD and/or HeFH on maximally tolerated statins
require less than 30 percent additional LDL-C lowering to achieve
treatment goals.
Esperion's mission as the Lipid Management Company is to deliver
once-daily, oral therapies that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
The Lipid Management Company
Esperion 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 pill, are targeted therapies that have been shown to
significantly lower 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
pill and bempedoic acid and the therapeutic potential of, clinical
development plan for, the bempedoic acid / ezetimibe combination
pill and bempedoic acid, including Esperion's timing, designs,
plans and announcement of results regarding its global pivotal
Phase 3 clinical development program for bempedoic acid and the
bempedoic acid / ezetimibe combination pill, Esperion's timing and
plans for submission of NDAs to the FDA and MAAs to the EMA and
Esperion's expectations for the market for therapies to lower
LDL-C, including the market adoption of bempedoic acid and the
bempedoic acid / ezetimibe combination pill, if approved, and the
expected upcoming milestones described in this press release. 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 Esperion’s studies, that positive
results from a clinical study of bempedoic acid may not be
sufficient for FDA or EMA approval or necessarily be predictive of
the results of future or ongoing clinical studies, that
notwithstanding the completion of Esperion’s Phase 3 clinical
development program for LDL-C lowering, the FDA or EMA may require
additional development in connection with seeking regulatory
approval, that existing cash resources may be used more quickly
than anticipated, 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.
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Elliot Fox W2O Group 212-257-6724
efox@w2ogroup.com
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