ANN ARBOR—Esperion Therapeutics Inc. (Nasdaq: ESPR), the Ann Arbor-based pharmaceutical startup developing a new class of cholesterol-fighting drugs, announced that its lead drug candidate, bempedoic acid, was included in the “Top 10 Medical Innovations for 2020” at Cleveland Clinic’s 2019 Medical Innovation Summit on Oct. 23.
The summit was comprised of a panel of physicians and scientists assembled to assess innovations and medicines that have the potential to enhance healthcare in the coming year.
Bempedoic acid and a bempedoic acid-ezetimibe combination tablet are under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Said Tim M. Mayleben, Esperion president and CEO: “This recognition highlights the need for innovative and cost-effective, oral, LDL-cholesterol lowering drugs and the potential of bempedoic to help patients taking maximally tolerated statins who need additional LDL-C lowering.”
Bempedoic acid reduces levels of low-density lipoprotein in the blood, as well as hsCRP, a marker of inflammation associated with cardiovascular disease, in patients who cannot tolerate today’s statin cholesterol-lowering drugs due to their side effects. Completed Phase 3 studies conducted in more than 4,000 patients, with more than over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering when used with low dose or no background statin.
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. Esperion 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 averse.” The CVOT—known as CLEAR Cardiovascular Outcomes Trial—is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.
Esperion’s mission is to deliver once-daily, oral therapies that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.
More at www.esperion.com.