Esperion has Phase 3 results for cardiology confab session

— Bempedoic Acid Achieved Additional 20% On-Treatment LDL-C Lowering on Background of Maximally Tolerated Statins —

— Study 1 (CLEAR Harmony) Provided the Largest Evidence to Date that Bempedoic Acid Is Safe when Added on to Maximally Tolerated Statins —

— Bempedoic Acid Provides Additional Oral Therapeutic Option to Safely Lower LDL-C in High-Risk ASCVD Patients Treated with Statins —

Esperion (NASDAQ:ESPR) today announced that the final results from the pivotal Phase 3 Study 1 (1002-040 or CLEAR Harmony) were presented at the European Society of Cardiology (ESC) Congress in Munich, Germany. This Phase 3 study evaluated the long-term safety, tolerability and efficacy of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statins. The late-breaking oral presentation was delivered by Professor Kausik K. Ray, MBChB, MD, MPhil, Professor of Public Health at the School of Public Health, Imperial College London and a Consultant Cardiologist. Topline results were announced earlier this year in May.

“The final data from Study 1 provide greater reassurance about the safety of bempedoic acid and reconfirm the efficacy over a longer period of time,” said Professor Ray.  “Our findings – supported by other ongoing bempedoic acid studies – may very soon offer clinicians an additional oral lipid lowering agent with which to treat high-risk patients.”

New data presented today as part of the final Study 1 results showed patients on bempedoic acid who were on a maximally tolerated statin dose had significantly fewer instances of new-onset or worsening diabetes than those on placebo who were on a maximally tolerated statin dose (5.4 percent compared to 3.3 percent; p<0.02).  In addition, serious AEs, including neoplasms, were balanced between the two study arms.  A detailed listing of all adjudicated cardiovascular events was provided, again showing balance between the two study arms.

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