Esperion Announces Oral Presentation on Genetic Validation of ATP Citrate Lyase Inhibition at the American College of Cardiology 66th Annual Scientific SessionMarch 6, 2017
ANN ARBOR, Mich., March 06, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced Brian A. Ference, M.D., M.Phil., M.Sc., F.A.C.C., Associate Professor of Medicine, Wayne State University School of Medicine, will present results from Mendelian randomization studies conducted to evaluate the effect of lower LDL-C mediated by genetic variants in the ATP Citrate Lyase (ACL) gene on the risk of cardiovascular events. The abstract, "Genetic Target Validation for ATP-Citrate Lyase Inhibition" will be presented in an oral presentation during the American College of Cardiology (ACC) 66th Annual Scientific Session on Sunday, March 19, 2017 at 8:51 a.m. Eastern Time at the Walter E. Washington Convention Center, Washington, DC in Room 147A. The abstract for this presentation is available on the ACC website at: http://bit.ly/2mvGXRx.
The importance of genetic validation of targets for LDL-C lowering and cardiovascular disease risk reduction through Mendelian randomization studies was highlighted at the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) inhibitor Endocrine-Metabolism Advisory Committee meetings in June 2015. Mendelian randomization studies have previously provided genetic target validation for several LDL-receptor-mediated LDL-C lowering therapies including 3-Hydroxy-3-Methyl-Glutaryl-Coezyme A (HMG-CoA) reductase (the enzyme target of statins), Niemann-Pick C1 Like 1 (NPC1L1) (the enzyme target for ezetimibe) and PCSK9is.
In early 2016, Esperion partnered with Dr. Ference to design and conduct Mendelian randomization studies to determine the genetic validity of inhibition of ACL, the enzyme target of bempedoic acid, for LDL-C lowering and the potential for cardiovascular disease risk reduction. The Mendelian randomization studies conducted on ACL by Dr. Ference, as with previous studies of other LDL-C lowering therapies mediated by the LDL receptor, identified a genetic score consisting of independently inherited variants in the ACL gene, which mimic the effect of ACL inhibition. Results from the studies demonstrated that these genetic variants have the same effect on the risk for cardiovascular events per unit change in LDL-C as variants that mimic the effects of statins, PCSK9is and ezetimibe. Dr. Ference and colleagues concluded that an ACL inhibitor such as bempedoic acid should reduce the risk of cardiovascular events by the same amount as statins per unit reduction in LDL-C.
Conference Call and Webcast Information
Esperion's lipid management team will host a conference call with Dr. Ference who will present his genetic target validation research and results. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 81690940. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com, along with slides to accompany this update. A webcast replay of the call will be available approximately two hours after completion of the event and will be archived on the Company's website for approximately 90 days.
With a targeted mechanism of action, bempedoic acid is a first-in-class, orally available, once-daily ACL inhibitor that reduces cholesterol biosynthesis and lowers elevated levels of LDL-C by up-regulating the LDL receptor, but with reduced potential for muscle-related side effects. Completed Phase 1 and 2 studies in more than 800 patients treated with bempedoic acid have produced clinically relevant 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.
Esperion's Commitment to Patients with Hypercholesterolemia
In the United States, 78 million people, or more than 20 percent of the population, have elevated LDL-C; an additional 73 million people in Europe and 30 million people in Japan also live with elevated LDL-C. Esperion's mission as the lipid management company is to provide patients and physicians with convenient, complementary, cost-effective, once-daily, oral therapies to significantly reduce elevated levels of LDL-C in patients inadequately treated with current lipid-modifying therapies. It is estimated that 40 million patients in the U.S. are taking statins with approximately 5-20 percent of these patients only able to tolerate less than the lowest approved daily starting dose of their statin and considered "statin intolerant". Esperion-discovered and developed, bempedoic acid is a targeted LDL-C lowering therapy in Phase 3 development. The Company has two Phase 3 products in development: 1) bempedoic acid (monotherapy) an oral, once-daily pill, and 2) an oral, once-daily fixed dose combination pill of bempedoic acid and ezetimibe (BA+EZ).
The Lipid Management Company
Esperion Therapeutics, Inc. is the lipid management company passionately committed to developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated LDL-C. Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced lipid management team at Esperion is committed to developing new LDL-C lowering therapies that will make a substantial impact on reducing global CVD; the leading cause of death around the world. Bempedoic acid, the Company's lead product candidate, is a targeted therapy that significantly reduces elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
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 therapeutic potential of, and clinical development plan for, bempedoic acid, including the potential effect of bempedoic acid on reducing risk of cardiovascular events. 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, delays or failures in the Company's studies, including the risk that U.S. Food and Drug Administration may require additional studies or data, that Esperion may need to change the design of its Phase 3 program, that positive results from a clinical study of bempedoic acid may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, that existing cash resources may be used more quickly than anticipated, that Esperion's global Phase 3 long-term safety and tolerability program for bempedoic acid may not produce sufficient safety or tolerability results or show meaningful change in LDL-C or other key lipid measures of patients, or the risk that other unanticipated developments or data could interfere with the scope of development and commercialization of bempedoic acid, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. 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 Therapeutics, Inc.