Esperion (Nasdaq: ESPR) and Otsuka Pharmaceutical Co., Ltd (Otsuka)
announced today that the primary endpoint was achieved in the Phase
3 trial in Japan for bempedoic acid as a potential treatment for
patients with hypercholesterolemia. The trial demonstrated
statistically significant outcomes on the primary endpoint for
bempedoic acid and highlighted its potential future value to
patients in Japan.
Bempedoic acid, created by Esperion Therapeutics, Inc.
(Esperion), has a novel mechanism of action that inhibits a
cholesterol synthesis pathway by acting on ATP (adenosine
triphosphate) citrate lyase, a citrate-degrading enzyme in the
liver. Bempedoic acid is marketed for the treatment of
hypercholesterolemia and cardiovascular risk reduction in several
regions of the world, including the United States and Europe. In
2020, Otsuka acquired exclusive development and commercialization
rights for bempedoic acid in Japan from Esperion and is currently
developing it domestically.
(https://www.otsuka.co.jp/en/company/newsreleases/2020/20200420_1.html)
This Phase 3 trial (NCT05683340) was conducted as a
placebo-controlled, randomized, multicenter, double-blind,
parallel-group comparative study in 96 patients with high LDL
cholesterol and in whom satins have insufficient effect or cannot
be tolerated. Trial participants were administered either 180 mg of
bempedoic acid or a placebo, orally, once a day, for 12 weeks to
evaluate the efficacy and safety of bempedoic acid.
In the preliminary results, the percentage change from baseline
in LDL-C at Week 12, the primary endpoint, was -25.25%% in the
group receiving bempedoic acid placebo group and -3.46% in the
placebo group, demonstrating positive outcomes with statistical
significance compared to placebo (p<0.01). Furthermore, the
safety and tolerability of bempedoic acid were consistent with
findings from previous trials, and no serious adverse events were
observed.
Further data analysis will be conducted, and Otsuka plans to
announces the results at a professional conference. Based on the
results of this trial, Otsuka plans to submit an New Drug
Application (NDA) in Japan in the latter half of 2024.
INDICATION NEXLIZET and NEXLETOL are
indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination
with other LDL-C lowering therapies, to reduce LDL-C in adults with
primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other
LDL-C lowering therapies, or alone when concomitant LDL-C lowering
therapy is not possible, to reduce LDL-C in adults with primary
hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION NEXLIZET and
NEXLETOL are contraindicated in patients with a prior
hypersensitivity to bempedoic acid or ezetimibe or any of the
excipients. Serious hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been
reported.
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, returning to baseline following
discontinuation of treatment. 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 may occur more frequently in patients over
60 years of age, in those taking corticosteroid or fluoroquinolone
drugs, in patients with renal failure, and in patients with
previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the
first sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in the primary hyperlipidemia
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 the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and greater than
placebo) observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, were urinary tract
infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes
trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at
an incidence of ≥2% and 0.5% greater than placebo were
hyperuricemia, renal impairment, anemia, elevated liver enzymes,
muscle spasms, gout, and cholelithiasis.
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 Esperion Therapeutics, Inc. Adverse Event
reporting line at 1-833-377-7633.
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 X at
twitter.com/EsperionInc. Forward-Looking
Statements This 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 net sales,
profitability, and growth of Esperion’s commercial products,
clinical activities and results, supply chain, commercial
development and launch plans, the outcomes and anticipated benefits
of legal proceedings and settlements, 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:
investorrelations@esperion.com
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
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