Esperion (NASDAQ: ESPR) today announced the presentation of results
from two oral presentations at the Late-Breaking Science Session
entitled, “Clinical trial updates on prevention and lipid lowering”
at the European Society of Cardiology (ESC) 2023 Congress, taking
place August 25-28, 2023, in Amsterdam, Netherlands.
“We are pleased to share additional results from our landmark
CLEAR Outcomes study in late-breaker presentations at ESC 2023,”
said Sheldon Koenig, President and CEO of Esperion. “These
prespecified analyses further reinforce the cardiovascular risk
reduction benefits of bempedoic acid in high-risk patients, not
only upon an initial cardiovascular event as described in the NEJM
publication, but also in those who experience more than one
cardiovascular event and in patients with diabetes. Importantly,
bempedoic acid use was not associated with an increased rate of new
onset diabetes, which is a key differentiating feature compared to
statins. We continue to believe bempedoic acid will have an
increasingly important place in the treatment paradigm to reduce
cardiovascular risk in a broad range of high-risk patients.”
Stephen Nicholls, MBBS, PhD (Victorian Heart Institute, Monash
University) presented a prespecified analysis in a late-breaker
presentation titled, “Impact of bempedoic acid on total
cardiovascular events in high-risk patients: analysis of the CLEAR
Outcomes trial.” The results reflect the totality of the benefit of
bempedoic acid on CV risk reduction, not just the first event.
Treatment with bempedoic acid is associated with a risk reduction
of 20% in total MACE-4 events (composite of major adverse
cardiovascular events including non-fatal myocardial infarction,
non-fatal stroke, coronary revascularization and cardiovascular
death), 17% in total MACE-3 events (composite of major adverse
cardiovascular events including non-fatal myocardial infarction,
non-fatal stroke and cardiovascular death), 31% in total myocardial
infarctions, and 22% in total coronary revascularizations.
“High risk patients face the prospect of not just one clinical
event in the future, but in many cases, patients experience
multiple events in the future. This data reinforces the importance
of cholesterol lowering in high risk patients with the potential to
prevent multiple events moving forward,” said Dr. Stephen
Nicholls.
A second late-breaker presentation, titled “Cardiovascular
Benefits and Risk of New Onset Diabetes by Glycaemic Status with
Bempedoic Acid: Prespecified Analyses of the CLEAR OUTCOMES trial,”
was presented by Kausik K Ray, MD, FMedSci (Imperial College
London). Of the 13,970 patients included in CLEAR Outcomes, 45.6%
had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia.
In this pre-specified analysis, bempedoic acid demonstrated a
benefit in patients with diabetes at baseline, showing a 17%
reduction in risk of MACE-4 and 20% reduction in risk of MACE-3. In
addition, bempedoic acid did not increase rates of new onset
diabetes in patients without diabetes, and was generally comparable
to placebo (11.1% vs 11.5%, respectively). Finally, bempedoic acid
did not result in increased HbA1c levels at 12 months or at end of
study in patients considered to have pre-diabetes or
normoglycemia.
“Patients with diabetes have twice the risk of cardiovascular
disease and lose on average half a decade of life compared to those
without and when cardiovascular disease also co exists this loss of
life years is a decade and a half” said Dr. Kausik K Ray. “Lowering
LDL-C with statins is beneficial in people with diabetes and
reduces cardiovascular disease. To date most treatments have been
as add on to statins in people with diabetes so the present
findings with bempedoic acid are noteworthy for several reasons.
Firstly, these analyses show that when statins cannot be tolerated,
bempedoic acid used as monotherapy can provide clinically
meaningful reductions in cardiovascular disease in people with
diabetes. Secondly, we know statins can increase the risk of
diabetes. Although bempedoic acid works in the same pathway as
statins no signal for increased risk of diabetes was noted,
providing assurance for the use of bempedoic acid in people without
diabetes that cardiovascular benefits come at the cost of worsening
glucose control.”
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.
Esperion TherapeuticsAt 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.
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.
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
Callahaninvestorrelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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