Esperion (NASDAQ: ESPR) today presented results from an analysis
comparing the cardiovascular risk reduction benefits of bempedoic
acid treatment with statin therapy per unit decrease in LDL-C, as
observed in the CLEAR Outcomes study, at the 2023 Endocrine Society
Meeting (ENDO 2023), being held in Chicago, IL June 15-18, 2023.
“We are pleased to present this analysis at ENDO 2023,
demonstrating that the cardiovascular risk reduction benefit of
bempedoic acid treatment is comparable to that of statins based on
an analysis of per unit decrease in LDL-C,” said Sheldon Koenig,
President and CEO of Esperion. “As highlighted in our New England
Journal of Medicine publication of CLEAR Outcomes earlier this
year, the benefit of bempedoic acid treatment is consistent with
the event reduction predicted by the CTT analysis, and generally
improved over time, similar to what was observed in statin outcomes
trials, with greater major adverse cardiovascular events (MACE-4)
benefit seen in those patients who remain on the study drug for the
duration of the study. Patients unable to tolerate statins or
achieve their LDL-C goals on statins alone represent approximately
one-third of all primary and secondary prevention patients, making
the significant benefits of bempedoic acid in this patient
population both evident and important.”
Key Highlights from the Analysis:
The analysis included results from all 13,970 statin-intolerant
patients from the CLEAR Outcomes trial with or at high risk for
cardiovascular (CV) disease and with an LDL-C level of at least
2.59 mmol/L (100 mg/dL). Using the CTT methodology, which aims to
provide reliable information about the effects on mortality and
morbidity of treatments that modify blood lipid levels for a wide
range of patient populations and risk groups, the analysis showed
that with statins, for every 1 mmol/L (39 mg/dL) reduction in LDL-C
observed at 12 months, there was an associated 22% reduction in the
major vascular events (MVE) endpoint, defined as the first
occurrence of any major coronary event (including coronary death or
non-fatal myocardial infarction), coronary revascularization, or
stroke. The primary endpoint in CLEAR Outcomes was a composite of
MACE-4 that included death from CV causes, non-fatal myocardial
infarction, non-fatal stroke, and coronary revascularization, thus
the methodology used in the analysis of statin Cardiovascular
Outcomes Trials (CVOTs) was used to determine whether bempedoic
acid provides similar cardiovascular risk reduction as statins, per
unit decrease in LDL-C.
Results from the CLEAR Outcomes:
- Bempedoic acid was associated with:
- a 21% decrease in LDL-C at 6 months compared with placebo;
- a 23% reduction in the risk of in the composite of fatal and
nonfatal myocardial infarction; (hazard ratio 0.77; 95% CI
0.66-0.91; p=0.002)
- a 19% reduction in the risk of coronary revascularization;
(hazard ratio 0.81; 95% CI 0.72-0.92; p=0.001)
- a 15% reduction in the risk of the MACE-3 composite of death
from CV causes, non-fatal myocardial infarction, and non-fatal
stroke; (hazard ratio 0.85; 95% CI 0.76-0.96; p=0.006) and
- a 13% reduction (hazard ratio 0.87; 95%CI 0.79-0.96; p=0.0037)
in the MACE-4 composite of major adverse cardiovascular events that
included death from CV causes, non-fatal myocardial infarction,
non-fatal stroke, and coronary revascularization in the intention
to treat analysis (all randomized patients)
- a 20% reduction (hazard ratio 0.80; 95%CI 0.72-0.89; p=0.0001)
in the MACE-4 composite of major adverse cardiovascular events in
the analysis of patients receiving the study drug
- Patients randomized to treatment with bempedoic acid achieved a
placebo-corrected lowering of LDL-C of 0.58 mmol/L (22.43 mg/dL) at
month 12, and an associated 15% reduction [hazard ratio 0.85 (95%CI
0.77, 0.94)] in the risk of the CTT MVE endpoint.
- When normalized to a 1.0 mmol/L LDL-C reduction as in the CTT,
the CV risk reduction with bempedoic acid shown via the CTT MVE
endpoint is comparable to the normalized risk reduction with
statins observed in the CTT meta-analyses of 22% [risk ratio 0.78,
95% CI 0.76, 0.80]. The beneficial effect of bempedoic acid on MVE
reduction generally improved over time, similar to what was
observed in statin CVOTs.
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 Trial CLEAR
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 regulatory submissions and potential
approvals, 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
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