Esperion (NASDAQ: ESPR) announced participation in the TRANSFORM
trial at the American Heart Association’s (AHA) 2023 Scientific
Sessions. TRANSFORM is a randomized control trial – sponsored by
Cleerly – that aims to enroll 7,500 patients who have pre-diabetes,
type 2 diabetes, or metabolic syndrome and have no symptoms of
heart disease. TRANSFORM aims to prove that a personalized care
strategy based on a Cleerly analysis of a patient’s actual disease
state is better than traditional care based on typical risk factors
for the primary prevention of cardiovascular events.
For TRANSFORM, Esperion is providing in-kind support of
NEXLIZET® (bempedoic acid and ezetimibe) Tablet, which reduces
low-density lipoprotein (LDL) cholesterol in adults. Other partners
for TRANSFORM include:
- American Heart Association - Providing educational materials
(Life’s Essential 8) as part of Cleerly’s membership in the
Technology and Innovator’s Network
- Agepha Pharmaceuticals - Providing in-kind support of LODOCO,
which reduces coronary inflammation
- Cleerly - Trial sponsor providing Cleerly software to analyze
patients’ coronary computed tomography angiography (CCTA) scans and
Cleerly’s investigational plaque staging system
- CPC Clinical Research - Academic research organization serving
as the clinical, data and statistical coordination center for the
trial
- Heartbeat Health - A virtual cardiology provider for the
trial
- Lexicon Pharmaceuticals - Providing in-kind support of Inpefa,
which significantly reduces the risk of death and
hospitalization/urgent visits to the doctor for heart failure
- Academic Leadership:
- Study Chair Deepak Bhatt, MD, MPH, FACC, FAHA, FESC, MSCAI,
Director of Mount Sinai Heart; Dr. Valentin Fuster Professor of
Cardiovascular Medicine, Icahn School of Medicine at Mount Sinai
Health System
- Co-Chair David Maron, MD, C.F. Rehnborg Professor and Professor
of Medicine; Director, Stanford Prevention Research Center,
Stanford University School of Medicine
- Co-Chair Marc Bonaca, MD, MPH, FAHA, FACC,
Executive Director of CPC Clinical Research, William R. Hiatt
Endowed Chair in Cardiovascular Research, Professor of Medicine;
Cardiology & Vascular Medicine and Director of Vascular
Research, University of Colorado School of Medicine
“We are thrilled to start the TRANSFORM trial, which we believe
will be a landmark study to demonstrate how a personalized care
strategy, fueled by AI, can revolutionize the way we think about
the prevention of cardiovascular events,” said James K. Min, MD,
FACC, FESC, MSCCT, Founder and CEO of Cleerly. “By focusing on the
individual’s actual coronary artery disease, rather than just risk
factors, we aim to prevent heart attacks. We look forward to the
progression of this trial with our partners and the results in
coming years.”
“Esperion is excited to collaborate with these nationally
recognized partners on this groundbreaking and revolutionary
study,” said JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of
Esperion. “Cardiovascular disease remains the number one killer of
men and women worldwide, so it’s critical to focus on prevention,
and utilizing AI combined with observation of the disease itself is
a progressive approach to preventing cardiovascular events before
they happen in the first place.”
TRANSFORM will enroll patients at 100-200 sites across the U.S.
and treat atherosclerosis in patients with either no symptoms or a
history of heart disease in order to reduce myocardial infarction
(heart attacks). The trial will utilize Cleerly’s investigational
plaque staging system in the experimental arm to inform treatment
and medication decisions made by providers.
“The TRANSFORM trial brings together the power of AI for staging
coronary disease and the well-documented benefits of advanced lipid
lowering, anti-thrombotic, anti-inflammatory and cardiometabolic
medications to create an individual care plan for patients at risk
for cardiovascular events,” said Udo Hoffmann, MD, MPH, Chief
Scientific Officer of Cleerly. “We are excited to partner with
academic leaders, professional societies, pharmaceutical companies
and healthcare providers to provide scientific proof for a new
paradigm in the primary prevention of cardiovascular disease that
is similar to what has been established for decades in the
prevention of cancer.”
Participants will be randomly assigned to the personalized care
strategy or to traditional care, and all participants will undergo
a CCTA scan at baseline and at 24 months. Patients assigned to
traditional care will be treated by their primary care providers
using available treatment guidelines, and CCTA results will be
provided at the end of the study. Separately, those assigned to the
personalized care strategy will have an investigational coronary
artery disease (CAD) plaque staging system report for both baseline
and at 24-months, and CCTA results will be provided to the central
cardiologist-led team for discussion and care planning with the
patient.
“As study chair and lead investigator, I am excited to embark on
the TRANSFORM trial, which we hope will showcase the transformative
potential of a personalized care strategy empowered by CCTA scans
and AI,” said Deepak L. Bhatt, MD, MPH, FACC, FAHA, FESC, MSCAI,
Director of Mount Sinai Heart and Dr. Valentin Fuster Professor of
Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai.
“This trial provides us the opportunity to revolutionize
cardiovascular event prevention and ultimately save lives from
heart disease. I eagerly anticipate the collaboration with all
valued partners across this trial and the forthcoming results to
help us shape the future of cardiovascular care.”
TRANSFORM trial recruitment is scheduled to close in fall 2025
and results can be expected in late 2028. For more information,
please visit transformtrial.org.
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.
Esperion Contact Information: Investors:
Alexis Callahaninvestorrelations@esperion.com(406)
539-1762 Media: Tiffany Aldrich
corporateteam@esperion.com (616) 443-8438
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jul 2023 to Jul 2024