Esperion Announces Positive CLEAR Outcomes Results To Be Presented as Late-Breaking Clinical Trial at ACC.23/WCC
February 20 2023 - 8:00AM
Esperion (NASDAQ: ESPR) announces that the landmark
Cholesterol
Lowering via
B
empedoic acid, an
ACL-Inhibiting
Regimen (CLEAR) Outcomes trial will be presented
as a late-breaking clinical trial at the American College of
Cardiology’s Annual Scientific Session Together With the World
Congress of Cardiology.
“Since releasing the positive topline results, we have fielded
enthusiastic inquiries from health care providers and scientific
leaders, so we are eager to share CLEAR Outcomes data in greater
detail,” said Sheldon Koenig, Esperion’s president and chief
executive officer. “We are honored to kick off the Late Breaking
Clinical Trial sessions at ACC.23/WCC and look forward to
showcasing the broad cardiovascular risk reduction results that
NEXLETOL has demonstrated.”
Late Breaking Clinical Trial
Presentation |
Title: |
|
|
CLEAR Outcomes Trial: Bempedoic Acid and
Cardiovascular Outcomes in Statin Intolerant Patients at High
Cardiovascular Risk |
Location: |
|
|
Main Tent (Great Hall) |
Date & Time: |
|
|
3/4/2022, 9:30 – 9:42 AM CST |
Speaker: |
|
|
Steven Nissen, MD, Chief Academic Officer of the Heart,
Vascular & Thoracic Institute at Cleveland Clinic |
|
|
|
|
Industry
Expert Theatre |
Title: |
|
|
A Next Step in LDL-C–Lowering Therapy: Oral Nonstatin
Therapies |
Location: |
|
|
Industry Expert Theatre #2, Location 2455 |
Date & Time: |
|
|
3/5/2022, 11:15 AM – 12:15 PM CST |
Speaker: |
|
|
Kausik Ray, BSc (hons), MBChB, FRCP (Lon), FRCP (Ed), MD, MPhil
(Cantab), FACC, FESC, FAHA |
|
|
|
|
CLEAR
Outcomes Late Breaking Clinical Trial Deep Dive – Session
408 |
Title: |
|
|
Bempedoic Acid And Cardiovascular Outcomes In Statin Intolerant
Patients At High Cardiovascular Risk |
Location: |
|
|
Main Tent (Great Hall) |
Date & Time: |
|
|
3/5/2022, 2:00 – 2:05 PM CST |
Speaker: |
|
|
Steven Nissen, MD, Chief Academic Officer of the Heart,
Vascular & Thoracic Institute at Cleveland Clinic |
INDICATIONNEXLETOL 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
NEXLETOL on cardiovascular morbidity and mortality has not been
determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
NEXLETOL 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: NEXLETOL is associated with an increased risk of tendon
rupture or injury. In clinical trials, tendon rupture occurred in
0.5% of patients treated with NEXLETOL 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 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
NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL 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 NEXLETOL be taken during breastfeeding.
Discontinue NEXLETOL when pregnancy is recognized, unless the
benefits of therapy outweigh the potential risks to the fetus.
Based on the mechanism of action, NEXLETOL 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.
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 future operations, commercial products and
expected growth, clinical development, 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, 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.
Contact:Corporate Communicationscorporateteam@esperion.com
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