Esperion (NASDAQ: ESPR) today announced the presentation of results
from a pre-specified, exploratory analysis of CLEAR Outcomes at the
2023 American Heart Association (AHA) Scientific Sessions. Results
were also simultaneously published in Circulation which can be
accessed here.
“The analysis presented at AHA and published in Circulation
highlights yet another important benefit of bempedoic acid
(contained in NEXLETOL® and NEXLIZET®): its potential to reduce
vascular inflammation in patients, including in those who are
intolerant of statins,” said JoAnne Foody, MD, FACC, FAHA, Chief
Medical Officer of Esperion. “Inflammation is an important
contributing factor to cardiovascular risk. CLEAR Outcomes
demonstrates that bempedoic acid not only reduces LDL-C levels but
also reduces an established marker of inflammation, which is a key
differentiator compared to other LDL-lowering therapies such as
ezetimibe monotherapy and PCSK9 inhibitors.”
“We know in 2023 that ‘lower is better’ is true both for
cholesterol and for inflammation,” said Paul Ridker, MD, MPH, of
the Brigham and Women’s Hospital and the Harvard Medical School and
a pioneer in the role of inflammation inhibition as a method going
beyond cholesterol to improve patient outcomes. “In the future, it
can be anticipated that virtually all atherosclerosis patients will
receive aggressive inflammation inhibition along with aggressive
cholesterol reduction,” Ridker added.
Dr. Ridker presented a pre-specified analysis in an oral
presentation titled, “Inflammation and Cholesterol as Predictors of
Cardiovascular Events and Risk Reduction with Bempedoic Acid Among
Statin Intolerant Patients: An Analysis of the CLEAR Outcomes
Trial.” The analysis focused on vascular inflammation, as measured
by the inflammatory marker hsCRP as a major determinant of
atherosclerotic risk regardless of background statin use. In the
exploratory analysis, participants with baseline hsCRP in the top
25% of all participants were 43% more likely to experience MACE,
twice as likely to experience cardiovascular death, and 121% more
likely to experience all-cause mortality compared to those in the
lowest 25%. In CLEAR Outcomes, patients who were randomized to
bempedoic acid experienced a 21.6% reduction in hsCRP compared to
placebo at 6 months.
INDICATIONNEXLIZET or NEXLETOL are 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
NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has
not been determined.
IMPORTANT SAFETY INFORMATIONNEXLIZET is
contraindicated in patients with a known hypersensitivity to
ezetimibe tablets. Hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been reported
with ezetimibe, a component of NEXLIZET.Hyperuricemia: Bempedoic
acid, a component of NEXLIZET and NEXLETOL, may increase blood uric
acid levels which may lead to gout. 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, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture occurred within weeks to months of starting
NEXLIZET or NEXLETOL. 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 NEXLIZET or NEXLETOL at
the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions In clinical trials of
bempedoic acid (a component of NEXLIZET and NEXLETOL) in ≥2% of
patients and greater than placebo, were upper respiratory tract
infection, muscle spasms, hyperuricemia, back pain, abdominal pain
or discomfort, bronchitis, pain in extremity, anemia, and elevated
liver enzymes.
Adverse reactions reported in ≥2% of patients treated with
ezetimibe (a component of NEXLIZET) and at an incidence greater
than placebo in clinical trials were upper respiratory tract
infection, diarrhea, arthralgia, sinusitis, pain in extremity
fatigue, and influenza.
In clinical trials of NEXLIZET, the most commonly reported
adverse reactions (incidence ≥3% and greater than placebo) observed
that not observed in clinical trials of bempedoic acid or
ezetimibe, were urinary tract infection, nasopharyngitis, and
constipation.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized
unless the benefits of therapy outweigh the potential risks to the
fetus. Because of the potential for serious adverse reactions in a
breast-fed infant, breastfeeding is not recommended during
treatment with NEXLIZET or NEXLETOL. Report pregnancies to the
Esperion Therapeutics, Inc. Adverse Event reporting line at
1-833-377-7633.
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 X 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 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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