Esperion to Host Analyst and Investor Day Event on July 10
The agenda will cover Esperion’s bempedoic acid franchise, its completed and ongoing Phase 3 studies, the scientific validation for its approach, additional context into the regulatory process, and insights from the provider, patient, and payer perspectives. The program will feature presentations from key opinion leaders, independent advisors, and a member of the Esperion Lipid Management Team, including:
- Jorge Plutzky, MD – Director, Cardiovascular Medicine, Brigham and Women’s Hospital
James Underberg, MD – Clinical Assistant Professor, Department of Medicine, NYU Langone Brian Ference, MD, MPhil, MSc, FACC– Director of Research in Translational Therapeutics, University of Cambridge Steven Nissen, MD, MACC – Chairman, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Cleveland Clinic John Jenkins, MD – Principal, Drug and Biological Products, Greenleaf Health; formerly Director of the Office of New Drugsin CDER ( Center for Drug Evaluation and Research) at FDA Mark Glickman– Chief Commercial Officer, Esperion Jane Barlow, MD, MPH, MBA, Executive Vice President and Chief Clinical Officer, Real Endpoints
The live event will be videocast simultaneously and accessible through the Events & Presentations page of the Esperion website at investor.esperion.com. Access to the event replay will be available approximately two hours after completion and will be archived on the Company's website for approximately 90 days.
About Esperion's Global Pivotal Phase 3 LDL-C Lowering Program
Esperion initiated its global, pivotal, Phase 3 clinical development program in
- Two pivotal studies evaluating bempedoic acid (Studies 1 & 2) in 3,009 patients with ASCVD on maximally-tolerated statin therapy, with top-line results reported in
May 2018, and expected in September 2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 & 4) in 614 patients with ASCVD, or at a high risk for ASCVD, considered statin intolerant, with top-line results reported in May and
March 2018, respectively;
- One pivotal study evaluating the bempedoic acid / ezetimibe combination pill (053 Study) in 382 patients with ASCVD, or at high risk for ASCVD, on maximally-tolerated statin therapy, with top-line results expected in August 2018.
Esperion plans to submit New Drug Applications (NDAs) to the
With a targeted mechanism of action, bempedoic acid is a first-in-class, complementary, orally available, once-daily ATP Citrate Lyase (ACL) inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Similar to statins, bempedoic acid also reduces hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 1, Phase 2 and Phase 3 studies conducted in more than 4100 patients, and over 2,700 patients treated with bempedoic acid, have produced LDL-C lowering results of up to 30 percent as monotherapy, approximately 50 percent in combination with ezetimibe and an incremental 20+ percent when added to stable statin therapy.
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. The company initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered "statin intolerant." The CVOT — known as Cholesterol Lowering via Bempedoic Acid, an ACL-inhibiting Regimen (CLEAR) Outcomes — is an event-driven, global, randomized, double-blind, placebo-controlled study expected to enroll approximately 12,600 patients with hypercholesterolemia and high CVD risk at more than 600 sites in approximately 30 countries.
Esperion's Commitment to Patients with Hypercholesterolemia
High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack or stroke. In the U.S., 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in
Esperion's mission as the
Esperion is the
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the regulatory approval pathway for the bempedoic acid / ezetimibe combination pill and bempedoic acid and the therapeutic potential of, clinical development plan for, the bempedoic acid / ezetimibe combination pill and bempedoic acid, including Esperion's timing, designs, plans and announcement of results regarding its global pivotal Phase 3 clinical development program for bempedoic acid and the bempedoic acid / ezetimibe combination pill, Esperion's timing and plans for submission of NDAs to the
Source: Esperion Therapeutics, Inc.