Esperion Announces Positive CLEAR Outcomes Results To Be Presented as Late-Breaking Clinical Trial at ACC.23/WCC
Esperion (NASDAQ: ESPR) announced that NEXLETOL® (bempedoic acid) has successfully met its primary endpoint of reducing major adverse cardiovascular events (MACE-4) in the CLEAR Outcomes trial. This trial will be showcased as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Session on March 4, 2022. The study involved patients with statin intolerance at high cardiovascular risk, highlighting the innovative oral non-statin therapy's potential. NEXLETOL is indicated to lower LDL-C levels and is particularly significant for patients requiring additional therapy beyond statins. Key safety information includes risks of hyperuricemia and tendon rupture.
- NEXLETOL is the first oral non-statin to meet MACE-4 primary endpoint.
- Presentation of CLEAR Outcomes trial results received enthusiastic interest from healthcare providers.
- Indicated for patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease.
- Broad cardiovascular risk reduction results showcased at a prominent scientific event.
- NEXLETOL's effect on cardiovascular morbidity and mortality has not been determined.
- Potential risks include hyperuricemia, leading to possible gout, and increased risk of tendon rupture.
– NEXLETOL® (bempedoic acid) is the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint –
ANN ARBOR, Mich., Feb. 20, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announces that the landmark Cholesterol Lowering via Bempedoic 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 | ||
INDICATION
NEXLETOL 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
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 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 Twitter 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 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 Communications
corporateteam@esperion.com
FAQ
What are the results of the CLEAR Outcomes trial for ESPR?
When and where will the CLEAR Outcomes trial results be presented?
What does NEXLETOL treat?
What safety concerns are associated with NEXLETOL?
What is the significance of the trial results for ESPR's stock?
