– Study Met Safety and Tolerability
Endpoints in 52-Week Study –– Bempedoic Acid
Achieved Additional 18% LDL-C Lowering in Patients on Maximally
Tolerated Statins and Provided Additional 19% hsCRP Reduction
–– 5-Component MACE Events in the Bempedoic Acid
Arm were 6.1% as Compared to 8.2% for Placebo ––
Reduction in HbA1c of 0.21% in Patients with Diabetes
–– Conference Call and Webcast on Monday, October
29 at 8:00 a.m. Eastern Time –
Esperion (NASDAQ: ESPR) today announced positive top-line results
from its global, pivotal Phase 3 clinical study (Study 2 or
1002-047). This trial was a 52-week, randomized, double-blind,
placebo-controlled study to evaluate the LDL-C lowering efficacy
and the safety and tolerability of bempedoic acid 180 mg compared
to placebo in patients with atherosclerotic cardiovascular disease
(ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
These results complete our global pivotal phase 3 LDL-C lowering
development program of bempedoic acid.
The study included 779 high cardiovascular risk patients taking
maximally tolerated statins who required additional LDL-C lowering.
The study achieved its efficacy endpoints and other key measures at
12 weeks, including:
- On-treatment LDL-C lowering of an additional 18 percent (vs.
placebo, p<0.001), and in the intent to treat analysis, LDL-C
lowering of an additional 17 percent (p<0.001)
- Reduction of 19 percent in high-sensitivity C-reactive protein
(hsCRP), an important marker of the underlying inflammation
associated with cardiovascular disease
- Reduction in hemoglobin A1c (HbA1c) of 0.21% vs. placebo in
patients with diabetes
Safety and Tolerability of Bempedoic Acid Over 52
Weeks
In this 52-week study, adjudicated major adverse cardiovascular
events (MACE) in the bempedoic acid arm as compared to placebo
were:
- 3-component MACE: 2.7 percent for bempedoic acid compared to
4.7 percent for placebo
- 4-component MACE: 5.7 percent for bempedoic acid compared to
7.8 percent for placebo
- 5-component MACE: 6.1 percent for bempedoic acid compared to
8.2 percent for placebo
In this study, bempedoic acid was observed to be safe and
well-tolerated. The results showed no clinically relevant
differences between the bempedoic acid and placebo treatment groups
in the occurrence of:
- Adverse events (AEs) with 70 percent and 71 percent,
respectively;
- Serious adverse events (SAEs) with 20 percent and 19 percent,
respectively;
- Discontinuations due to AEs with 11 percent and 9 percent,
respectively;
- Fatal adverse events with 1.1 percent and 0.8 percent,
respectively. No fatal adverse events were determined to be related
to study medication. CV deaths were balanced between the
study arms (0.8% vs. 0.8%). The bempedoic acid arm included a case
of gas poisoning and a case of sepsis as a complication of planned
abdominal surgery. No fatal AEs due to neoplasms.
"This is the final clinical study from our global, pivotal Phase
3 LDL-C lowering program for bempedoic acid. We are now one step
closer to being able to provide convenient, cost-effective and
complementary LDL-C lowering therapies for use by patients who
require additional LDL-C lowering,” said Tim M. Mayleben, president
and chief executive officer of Esperion. "We express our sincere
thanks to all of the clinical trial investigators, site
coordinators and patients in this study for their dedication in
helping us complete the clinical development of bempedoic acid for
patient with hyperlipidemia.”
Design of Global Pivotal Phase 3 Study 2
(1002-047)
The 52-week, global pivotal Phase 3 randomized, double-blind,
placebo-controlled, multicenter study evaluated the efficacy and
safety of bempedoic acid 180 mg/day versus placebo. The study was
conducted at 93 sites in North America and Europe. A total of 779
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 safety and tolerability of
bempedoic acid versus placebo, the 24-week and 52-week LDL-C
lowering efficacy of bempedoic acid versus placebo, and its effects
on other risk markers after 12 weeks of treatment, including
hsCRP.
Conference Call and Webcast Information
Esperion's Lipid Management Team will host a conference call and
webcast tomorrow, Monday, October 29, 2018, at 8:00 a.m.
Eastern Time to discuss these Phase 3 study results. The call can
be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184
(international) five minutes prior to the start of the call and
providing access code 3669826. A live audio webcast can be accessed
on the investors and media section of the Esperion website at
investor.Esperion.com. Access to the webcast replay 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 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 3,008 patients with ASCVD on maximally-tolerated statins,
with top-line results reported in May 2018 and in October
2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 &
4) in 613 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 top-line
results reported in August.
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 a
monotherapy, 35% 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 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 more than 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
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
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jul 2023 to Jul 2024