— Bempedoic Acid Achieved Additional 20%
On-Treatment LDL-C Lowering on Background of Maximally
Tolerated Statins —
Esperion (NASDAQ:ESPR) today announced that the final results from
the pivotal Phase 3 Study 1 (1002-040 or CLEAR Harmony) were
presented at the European Society of Cardiology (ESC) Congress in
Munich, Germany. This Phase 3 study evaluated the long-term safety,
tolerability and efficacy of bempedoic acid 180 mg versus placebo
in high-risk patients with atherosclerotic cardiovascular disease
(ASCVD) who are inadequately controlled with current
lipid-modifying therapies, including maximally tolerated statins.
The late-breaking oral presentation was delivered by Professor
Kausik K. Ray, MBChB, MD, MPhil, Professor of Public Health at the
School of Public Health, Imperial College London and a Consultant
Cardiologist. Topline results were announced earlier this year in
May.
“The final data from Study 1 provide greater reassurance about
the safety of bempedoic acid and reconfirm the efficacy over a
longer period of time,” said Professor Ray. “Our findings –
supported by other ongoing bempedoic acid studies – may very soon
offer clinicians an additional oral lipid lowering agent with which
to treat high-risk patients.”
New data presented today as part of the final Study 1 results
showed patients on bempedoic acid who were on a maximally tolerated
statin dose had significantly fewer instances of new-onset or
worsening diabetes than those on placebo who were on a maximally
tolerated statin dose (5.4 percent compared to 3.3 percent;
p<0.02). In addition, serious AEs, including neoplasms,
were balanced between the two study arms. A detailed listing
of all adjudicated cardiovascular events was provided, again
showing balance between the two study arms.
Details on the presentation are as follows:
Title: Late Breaking Pharmacological Science:
CLEAR Harmony – Long-term safety, tolerability and efficacy of
bempedoic acid vs. placebo in high cardiovascular risk patients
with LDL-C above 1.8 mmol/L on maximally tolerated statin
therapyDate: August 25, 2018Time:
11:45 am (CET)Location: Messe München,
Bratislava-Village 2
Design of Global Pivotal Phase 3 Study 1
(1002-040)
The 52-week, global, pivotal Phase 3 randomized, double-blind,
placebo-controlled, multicenter study evaluated the long-term
safety and tolerability of bempedoic acid 180 mg/day versus placebo
in high-risk patients with ASCVD and/or heterozygous familial
hypercholesterolemia (HeFH) with LDL-C levels of at least 70 mg/dL
(1.8 mmol/L) who are inadequately controlled with current
lipid-modifying therapies, including maximally tolerated statin
therapy. The study was conducted at 117 sites in the U.S., Canada
and Europe. A total of 2,230 patients were randomized 2:1 to
receive bempedoic acid or placebo. The secondary objective was to
assess the 12-week LDL-C lowering efficacy of bempedoic acid versus
placebo. Tertiary objectives were to assess the effect of bempedoic
acid on other lipid parameters and risk markers, including
hsCRP.
An open-label extension study (1002-050) was initiated in early
2017 and is fully enrolled with 1,462 patients.
About Esperion's Global Pivotal Phase 3 LDL-C Lowering
Program
Esperion initiated its global, pivotal, Phase 3 clinical
development program 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 in patients with atherosclerotic cardiovascular disease
(ASCVD), or who are 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 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 (Studies 1 &
2) in 3,009 patients with ASCVD on maximally-tolerated statins,
with top-line results reported in May 2018, and expected in
September 2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 &
4) in 614 patients with ASCVD, or at a high risk for ASCVD,
considered statin intolerant, with top-line results reported in May
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 topline
results expected 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
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 over 4000 patients, and
approximately 2,900 patients treated with bempedoic acid, have
produced LDL-C lowering results of up to 30 percent as monotherapy,
48 percent in combination with ezetimibe as monotherapy, and an
additional 20 percent on maximally tolerated statins.
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 Cholesterol Lowering via Bempedoic Acid,
an ACL-inhibiting Regimen (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 up to 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. 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 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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