– Bempedoic Acid Lowered LDL-C and Was Well Tolerated in Children Aged 6-17 Years –
– A Secondary Analysis of CLEAR Outcomes Reports on Patient Factors Associated With 30% or Greater Reduction in LDL-C in Statin Intolerant Adults –
ANN ARBOR, Mich., May 26, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a Phase 2 study of bempedoic acid in children, along with an additional post hoc analysis from CLEAR Outcomes describing patient traits associated an enhanced LDL-C lowering with bempedoic acid. These data were presented as moderated Science at a Glance sessions at the European Atherosclerosis Society (EAS) Congress 2026 taking place on May 24-27, 2026, in Athens, Greece.
“The data from CLEAR Path 1 in pediatric patients with familial hypercholesterolemia gives promise for bempedoic acid as a potentially safe and effective additional lipid lowering agent for use in children who carry a greater lifetime cardiovascular risk and will further inform Phase 3 studies,” said Christie M Ballantyne, MD, Professor of Medicine and Chief of Cardiology and Cardiovascular Research at Baylor College of Medicine and member of the Esperion Pediatric Study Steering Committee. “The 30% or greater reduction in LDL-C more often observed in women, those with higher baseline LDL-C, and with concurrent baseline ezetimibe use as seen in the post-hoc analysis of CLEAR Outcomes confirms what was previously seen in the earlier bempedoic acid pooled hyperlipidemia trials and highlights the important role of bempedoic acid as both an adjunct and alternative lipid lowering therapy to statins.”
“These new analyses add to the breadth of clinical evidence demonstrating the robust LDL cholesterol lowering of NEXLETOL® (bempedoic acid) across a wide range of patient populations,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “These data further support use of our combination product NEXLIZET® (bempedoic acid/ezetimibe) to help patients achieve their LDL-C goals and reduce cardiovascular risk. We are also proud to present data supporting the use of bempedoic acid in children with heterozygous familial hypercholesterolemia and which informs our Phase 3 pediatric studies.”
Key data presented at EAS Congress 2026
- Bempedoic Acid In Children Aged 6-17 Years With Heterozygous Familial Hypercholesterolaemia: A Phase 2 Study presented by Samuel S Gidding, MD (Geisinger Health)
Highlights
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- The variable dosing of bempedoic acid, as determined by patient weight in this study, resulted in similar drug exposure (levels) to that in adults, and supports the doses of bempedoic acid to be used in further clinical studies.
- Bempedoic acid, when given as a tablet in addition to patient’s existing lipid lowering treatments, reduced LDL-C in pediatric patients (range 6-25%) and did not raise any new safety concerns.
- Factors Associated With Enhanced LDL-Cholesterol Lowering With Bempedoic Acid Among Statin-Intolerant Patients From Clear Outcomes presented by Christie M Ballantyne, MD (Baylor College of Medicine)
Highlights
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- In CLEAR Outcomes, 42% of patients in the bempedoic acid arm demonstrated a ≥30% LDL‐C reduction at 3 months, a reduction on par with moderate intensity statins.
- Patient factors associated with achieving a greater LDL-C reduction included female sex, higher starting LDL-C, and concurrent use of ezetimibe.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- bempedoic acid, a component of NEXLIZET and NEXLETOL, is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
- as an adjunct to diet and exercise:
- NEXLIZET is indicated to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
- NEXLETOL is indicated, 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 hypercholesterolemia, 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. Monitor as clinically indicated and initiate treatment with urate-lowering drugs as appropriate.
- Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred in 0.5% of patients treated with bempedoic acid in primary hypercholesterolemia trials, versus 0% on placebo. In the cardiovascular outcomes trial, the rates were 1.2% for bempedoic acid and 0.9% for placebo. 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 hypercholesterolemia trials of bempedoic acid 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.
- The most common 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, at an incidence of ≥2% and 0.5% greater than placebo, were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
- Concomitant use of NEXLIZET or NEXLETOL with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided due to the potential for increased risk of simvastatin- or pravastatin-related myopathy. Concomitant use with fibrates may increase triglycerides and decrease high-density lipoprotein cholesterol. Monitor and adjust therapies as recommended.
- Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. The benefits of breastfeeding should be considered along with the mother’s clinical need for NEXLIZET or NEXLETOL and any potential adverse effects on the breastfed infant from NEXLIZET or NEXLETOL or from the underlying maternal condition.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.
With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
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 and business development plans, current and planned operational expenses, expected profitability, 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 profitability, 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, business development, 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:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
