Esperion (NASDAQ: ESPR) announced the results from the
pre-specified, primary prevention CLEAR Outcomes subgroup analysis
at the 83rd American Diabetes Association (ADA) Scientific
Sessions.
Results from this primary prevention analysis show a significant
reduction in cardiovascular risk, including a 36% risk reduction of
MACE-3 (composite of major adverse cardiovascular events including
non-fatal myocardial infarction, non-fatal stroke and
cardiovascular death), and a 30% risk reduction of MACE-4
(composite of major adverse cardiovascular events including
non-fatal myocardial infarction, non-fatal stroke, coronary
revascularization and cardiovascular death) in the primary
prevention population. The data were simultaneously published in
the renowned peer-reviewed Journal of the American Medical
Association (JAMA). The article, entitled “Bempedoic Acid for
Primary Prevention of Cardiovascular Events in Statin-Intolerant
Patients,” can be found here.
“We are thrilled with the results from the primary prevention
analysis of the CLEAR Outcomes study presented at the ADA
Scientific Sessions and simultaneously published in the Journal of
the American Medical Association,” said Sheldon Koenig, President
and CEO of Esperion. “This analysis represents a significant
opportunity to expand how many people can benefit from bempedoic
acid, to the tune of 70 million patients. This large subgroup
analysis supports the use of bempedoic acid, available as NEXLETOL®
or in combination with ezetimibe as NEXLIZET®, in the primary
prevention population, for those patients at high risk for
atherosclerotic cardiovascular disease (ASCVD) or a cardiovascular
event. Now, more than ever, we believe that bempedoic acid offers
an evidence-based option for patients who are not on statins and
those not able to tolerate statins, as well as those who would
benefit from primary or secondary cardiovascular event prevention
strategies.”
“These findings demonstrate the importance of lowering LDL
cholesterol in people who are at high risk of having a heart
attack, but who have not had one to date,” noted Stephen Nicholls,
MD, Director of the Victorian Heart Hospital and Institute and
Monash University, Melbourne, Australia. “Many of these patients
could not tolerate statins and needed a new option, and CLEAR
Outcomes demonstrated that bempedoic acid proved to be effective
not only in lowering LDL cholesterol, but also in lowering the rate
of cardiovascular risk in primary prevention patients.”
JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of Esperion
commented, “Patients at high risk of cardiovascular disease without
a history of ASCVD, including those with diabetes, have few proven
lipid lowering therapies that reduce cardiovascular risk. Bempedoic
acid’s novel ATP citrate lyase inhibition is the first LDL-C
lowering mechanism since statins to demonstrate cardiovascular risk
reduction in primary prevention patients in a cardiovascular
outcomes trial. Other non-statin LDL-C lowering therapies, such as
ezetimibe and PCSK9s, have only been studied in secondary
prevention (ASCVD) populations. We believe this analysis from CLEAR
Outcomes supports the use of bempedoic acid earlier in the
treatment paradigm to achieve LDL-C goals and reduce cardiovascular
risk in a broad range of primary and secondary prevention
patients.”
Key Highlights from the Primary Prevention
Analysis:
The primary prevention patient population included 4,206
statin-intolerant patients from the CLEAR Outcomes trial (30% of
the total 13,970 patients) who had no prior cardiovascular events,
LDL-C level greater than or equal to 100 mg/dL at the start of the
study, and who were at high risk for cardiovascular events
(“primary prevention group”). Patients were randomized to receive
oral bempedoic acid 180 mg daily (n=2,100) or placebo (n=2,106).
Notable groups represented in this analysis included 59% (n=2,481)
female, 18.5% (n=777) Hispanic/Latino ethnicity, and 66.1%
(n=2,781) patients with diabetes.
For the primary endpoint, bempedoic acid demonstrated the
following versus placebo:
- 30% reduced risk [hazard ratio (HR) 0.70 (95% CI 0.55-0.89)] of
the primary efficacy endpoint of MACE-4
- This equates to 43 patients being treated with bempedoic acid
to prevent one primary cardiovascular event
For key secondary endpoints, bempedoic acid demonstrated the
following versus placebo:
- 39% reduced risk for cardiovascular mortality; HR 0.61 (95% CI
0.41-0.92)
- 39% reduced risk of myocardial infarction; HR 0.61 (95% CI
0.39-0.98)
- 36% reduced risk of MACE-3; HR 0.64 (95% CI 0.48-0.84)
- 27% reduced risk for all-cause mortality; HR 0.73 (95% CI
0.54-0.98)
Bempedoic Acid Effects on LDL Cholesterol and
High-Sensitivity C-Reactive Protein:
- 21.5% reduction in high sensitivity C-reactive protein (hsCRP)
after 12 months of treatment vs. placebo
- 21.3% reduction in LDL-C after 6 months of treatment vs.
placebo
Adverse events in this primary prevention subpopulation were
consistent with those seen in the overall study population and
included higher incidences of hyperuricemia (12.1% vs. 6.3%), gout
(2.6% vs. 2.0%), and cholelithiasis (2.5% vs. 1.1%) for those
receiving bempedoic acid versus placebo.
INDICATIONBempedoic acid is indicated as an
adjunct to diet and maximally tolerated statin therapy for the
treatment of adults with heterozygous familial hypercholesterolemia
or established atherosclerotic cardiovascular disease who require
additional lowering of LDL-C. Limitations of Use: The effect of
bempedoic acid on cardiovascular morbidity and mortality has not
been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
Bempedoic acid may increase blood uric acid levels. Hyperuricemia
may occur early in treatment and persist throughout treatment, and
may lead to the development of gout, especially in patients with a
history of gout. Assess uric acid levels periodically as clinically
indicated. Monitor for signs and symptoms of hyperuricemia, and
initiate treatment with urate-lowering drugs as appropriate.Tendon
Rupture: Bempedoic acid is associated with an increased risk of
tendon rupture or injury. In clinical trials, tendon rupture
occurred in 0.5% of patients treated with bempedoic acid versus 0%
of patients treated with placebo, and involved the rotator cuff
(the shoulder), biceps tendon, or Achilles tendon. Tendon rupture
occurred within weeks to months of starting bempedoic acid. Tendon
rupture may occur more frequently in patients over 60 years of age,
patients taking corticosteroid or fluoroquinolone drugs, patients
with renal failure, and patients with previous tendon disorders.
Discontinue bempedoic acid at the first sign of tendon rupture.
Avoid bempedoic acid in patients who have a history of tendon
disorders or tendon rupture.
Adverse Reactions: In clinical trials, the most
commonly reported adverse reactions were upper respiratory tract
infection, muscle spasms, hyperuricemia, back pain, abdominal pain
or discomfort, bronchitis, pain in extremity, anemia, and elevated
liver enzymes. Reactions reported less frequently, but still more
often than with placebo, included benign prostatic hyperplasia and
atrial fibrillation.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use results in increased concentrations and increased
risk of simvastatin or pravastatin-related myopathy. Use with
greater than 20 mg of simvastatin or 40 mg of pravastatin should be
avoided.
Lactation and Pregnancy: It is not recommended
that bempedoic acid be taken during breastfeeding. Discontinue
bempedoic acid when pregnancy is recognized, unless the benefits of
therapy outweigh the potential risks to the fetus. Based on the
mechanism of action, bempedoic acid may cause fetal harm.
Please see full Prescribing Information here.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and
ezetimibe) Tablet. The CLEAR Program seeks to generate important
clinical evidence on the safety and efficacy of bempedoic acid, a
first in a class ATP citrate lyase inhibitor contained in NEXLETOL
and NEXLIZET and its potential role in addressing additional
critical unmet medical needs. More than 60,000 people will have
participated in the program by the time of its completion. The
CLEAR Program includes 5 label-enabling Phase III studies as well
as other key Phase IV studies with the potential to reach more than
70 million people with or at risk for CVD based on elevated
LDL-C.
Esperion Therapeutics At Esperion, we
discover, develop, and commercialize innovative medicines to help
improve outcomes for patients with or at risk for cardiovascular
and cardiometabolic diseases. The status quo is not meeting the
health needs of millions of people with high cholesterol – that is
why our team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com and follow
us on Twitter at twitter.com/EsperionInc.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding marketing strategy and commercialization
plans, current and planned operational expenses, future operations,
commercial products, clinical development, including the timing,
designs and plans for the CLEAR Outcomes study and its results,
plans for potential future product candidates, financial condition
and outlook, including expected cash runway, and other statements
containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. 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, the impact of the ongoing
COVID-19 pandemic on our business, revenues, results of operations
and financial condition, the net sales, profitability, and growth
of Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch plans, the outcomes
of legal proceedings, and the risks detailed in Esperion’s filings
with the Securities and Exchange Commission. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and 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.
Esperion Contact Information: Investors: Alexis
Callahaninvestorelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From May 2024 to Jun 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2023 to Jun 2024