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Esperion Therapeutics Announces Initiation of Phase 3 Clinical Program With Long-Term Safety and Tolerability Study
ANN ARBOR, Mich., Jan. 13, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, today announced the start of a global Phase 3 long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017.
ETC-1002-040 is a Phase 3 randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 900 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study will enroll patients at approximately 125 sites in the U.S., Canada and the European Union. The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on other lipid and cardiometabolic risk markers, including LDL-C and high-sensitivity C-reactive protein.
This study marks the launch of the Phase 3 clinical program — known as Cholesterol Lowering via ETC-1002, an ACL-inhibiting Regimen (CLEAR) — which will be focused on the development of bempedoic acid for statin intolerant patients with uncontrolled LDL-C levels. The Company will provide details of the full Phase 3 global development strategy in the second quarter of 2016. Separately, the Company anticipates formalizing and communicating the design of the planned cardiovascular outcomes trial in the second quarter of 2016.
"We are pleased to announce the launch of our Phase 3 program, CLEAR, with the initiation of this long-term safety study," said Tim M. Mayleben, president and chief executive officer of Esperion. "We continue to make progress with regulatory authorities to finalize the Phase 3 global development strategy, and data from this study will help confirm the safety profile of bempedoic acid over the long term, which is foundational for this program."
Esperion's Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with hypercholesterolemia by developing therapies to lower LDL-C. Esperion scientists discovered bempedoic acid and the LDL-C lowering therapy is in late stage development. Esperion plans to develop both bempedoic acid and a fixed dose combination of bempedoic acid and ezetimibe with a particular focus on patients with hypercholesterolemia who are considered intolerant of statin therapy. It is estimated that approximately 10% of patients who are prescribed statins, 3.5 million patients in the U.S., are considered statin intolerant.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-C lowering therapies for the treatment of patients with hypercholesterolemia. Bempedoic acid, the Company's lead product candidate, is an inhibitor of ATP Citrate Lyase, a well-characterized enzyme on the cholesterol biosynthesis pathway. Bempedoic acid inhibits cholesterol synthesis, decreases intracellular cholesterol, up-regulates LDL-receptors, and causes increased LDL-C clearance and reduced plasma levels of LDL-C. 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 and the fixed-dose combination of bempedoic acid and ezetimibe, the design and timing of the announcement of top-line results from ETC-1002-040, the Company's plans regarding its Phase 3 program and the planned cardiovascular outcomes trial. 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 patient enrollment in the Company's studies, the risk that FDA may require additional studies or data, including prior to approval that might cause approval to be delayed, that Esperion may need to change the design of its Phase 3 program, including upon feedback from regulatory authorities, that positive results from a clinical study of bempedoic acid and the fixed-dose combination of bempedoic acid and ezetimibe may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or in all statin doses, including high doses, or the risk that other unanticipated developments or data could interfere with the scope of development and commercialization of bempedoic acid and the fixed-dose combination of bempedoic acid and ezetimibe, as well as other risks detailed in Esperion's filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. 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.
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