Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24
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Insights
The acceptance of Esperion's subgroup analyses for presentation at the ACC.24 reflects ongoing research efforts in the cardiovascular field, particularly in the management of high cholesterol through pharmacological interventions. Bempedoic acid, as an ATP citrate lyase inhibitor, offers a novel mechanism of action distinct from statins, which have been the cornerstone of dyslipidemia management. The focus on statin-intolerant populations, including women, Hispanic/Latinx patients and those with obesity, is significant. These groups are often underrepresented in clinical trials and their inclusion can provide insights into the efficacy and safety of bempedoic acid across diverse populations.
From a scientific standpoint, the potential impact of this research on clinical practice could be substantial. With cardiovascular disease remaining the leading cause of death globally, advancements in lipid-lowering therapies are essential. The CLEAR Outcomes trial data could influence future guidelines, particularly if the sub-analyses demonstrate significant benefits or identify specific patient populations that could derive greater benefit from bempedoic acid therapy.
Esperion's participation in a moderated session discussing payer rejections and out-of-pocket costs is a critical aspect of healthcare delivery. Accessibility and affordability of new medications are key determinants of their real-world impact. Despite clinical efficacy, if bempedoic acid is not adequately covered by insurance providers or is priced out of reach for patients, its potential to improve cardiovascular outcomes will be limited. The discussion on patient access to bempedoic acid therapy could provide valuable information on the current barriers within the healthcare system and potential strategies to overcome them.
Moreover, the focus on underserved populations in the CLEAR Outcomes trial aligns with a broader shift in healthcare towards health equity. Addressing disparities in cardiovascular care is not only a moral imperative but also a practical one, as it can lead to better overall health outcomes and reduced long-term healthcare costs. Insights from the trial could inform policymakers and healthcare providers on how to tailor interventions for these specific populations, potentially influencing health policy and resource allocation.
The CLEAR Outcomes trial and subsequent data presentations at ACC.24 could have implications for Esperion's market positioning and stock performance. The pharmaceutical market for cholesterol-lowering drugs is competitive, with established players and numerous generic options available. Esperion's ability to differentiate its products, NEXLETOL and NEXLIZET, hinges on demonstrating clear benefits over existing therapies, especially for statin-intolerant patients.
Investors will be closely monitoring the outcomes of these presentations for signals on the drug's market potential. Positive data could lead to increased prescribing by clinicians and, consequently, higher sales revenue for Esperion. Conversely, if the data fails to impress or raises concerns about efficacy or safety in certain populations, it could negatively affect the company's valuation. It is also important to consider the long-term potential of bempedoic acid in the context of ongoing research and development in the lipid management space.
ANN ARBOR, Mich., March 25, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the acceptance of three CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Outcomes subgroup analyses as poster presentations at the 2024 American College of Cardiology’s Annual Scientific Session (ACC.24) in Atlanta, Georgia. Additionally, the Company will participate in a moderated session in partnership with UT Southwestern Medical Center, host an industry expert theatre, and have a commercial and medical information booth during ACC.24.
"Esperion welcomes the opportunity to showcase additional data from our pivotal CLEAR Outcomes trial at the American College of Cardiology's Annual Scientific Session," said JoAnne Foody, MD, Chief Medical Officer for Esperion. "Complementing the ACC.24 theme of Cardiovascular Care for All, we will highlight our commitment to underserved populations and present subset analyses in women and Hispanic/Latinx patients as well as in patients with obesity."
CLEAR Outcomes Sub-group Poster Presentations
| Title: | Characteristics and Outcomes for Statin-Intolerant Women Receiving Bempedoic Acid in the CLEAR Outcomes Trial |
| Session: | 1213 |
| Location: | Hall B4-5 |
| Date & Time: | 4/6/24, 9:45 – 10:30 AM ET |
| Speaker: | Leslie Cho, MD; Cleveland Clinic, Cleveland, Ohio |
| Title: | Characteristics and Outcomes for Statin-Intolerant Hispanic/Latinx Patients Receiving Bempedoic Acid; Results from a CLEAR Outcomes Pre-Specified Sub-Analysis |
| Session: | 1294 |
| Location: | Hall B4-5 |
| Date & Time: | 4/6/24,1:45 – 2:30 PM ET |
| Speaker: | Fatima Rodriguez, MD, MPH; Stanford Cardiovascular Institute, Stanford Medicine, Stanford, California |
| Title: | Bempedoic Acid and Cardiovascular Disease Outcomes in Patients with Obesity: A CLEAR Outcomes Subset Analysis |
| Session: Location: Date & Time: Speaker: | 1433 Hall B4-5 4/7/24, 1:15 – 2:00 PM ET Harold Bays, MD, FOMA, FTOS, FACC, FNLA, FASPC; Louisville Metabolic and Atherosclerosis Research Center, University of Louisville School of Medicine, Louisville, Kentucky |
| Moderated Presentation | |
| Title: Session: Location: Date & Time: Speaker: | Impact of Payer Rejections and Out-Of-Pocket Costs on Patient Access to Bempedoic Acid Therapy 1092 Moderated Poster Theatre 08 4/7/24, 3:15 – 3:25 PM ET Jimin Hwang, MD; UT Southwestern Medical Center, Dallas, Texas |
| Industry Expert Theatre | |
| Title: Location: Date & Time: Speaker: | A Next Step in Cardiovascular Disease Management Theatre #2 4/7/2024, 11:15 AM – 12:15 PM ET Manesh Patel, MD Chief, Division of Cardiology, Director Duke Heart Center |
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.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
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:
Alexis Callahan
investorrelations@esperion.com
(406) 539-1762
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
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