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Esperion Announces Positive Top-Line Results From Phase 2 Study of Bempedoic Acid / Ezetimibe Combination Plus Atorvastatin

1002-038 Study Meets Primary Endpoint With a Robust 64% LDL-C Lowering Efficacy
– Clinically Relevant 48% hsCRP Reduction
The Combination Therapy Was Observed to be Safe and Well-Tolerated
– Conference Call and Webcast on Tuesday, August 8, 2017 at 8:30 a.m. Eastern Time –

ANN ARBOR, Mich., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (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 positive top-line results from the Phase 2 clinical study (1002-038), also known as the triplet oral therapy study, evaluating the LDL-C lowering efficacy and safety of the bempedoic acid / ezetimibe combination (bempedoic acid 180 mg, ezetimibe 10 mg) plus atorvastatin 20 mg, versus placebo, in patients with hypercholesterolemia.

Photos accompanying this announcement are available at

The six-week study met its primary endpoint of greater LDL-C lowering from baseline of 64 percent (p<0.001) in the bempedoic acid / ezetimibe combination plus atorvastatin group, as compared to placebo. Ninety five percent of patients receiving treatment achieved greater than or equal to 50 percent LDL-C lowering reduction and 90 percent achieved LDL-C levels of less than 70 mg/dL.

The bempedoic acid / ezetimibe combination plus atorvastatin also demonstrated a reduction of 48 percent (p<0.001) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease.

There were no reported serious adverse events (SAEs), no difference in muscle-related adverse events (AEs), or discontinuations due to muscle-related AEs, in the treatment group, as compared to the placebo group. The bempedoic acid / ezetimibe combination plus atorvastatin produced no elevations in liver function tests (ALT/AST) or creatine kinase (CK). The bempedoic acid / ezetimibe combination plus atorvastatin was observed to be safe and well-tolerated.

“Patients in this study experienced nearly a 100 mg/dL drop in their LDL-C levels on the combo plus atorvastatin. These highly positive study results of the combination therapy demonstrate very robust and remarkably consistent LDL-C lowering with what appears to be optimal safety and tolerability," said Tim M. Mayleben, president and chief executive officer of Esperion. “Next year we intend to initiate additional studies to further explore these complementary oral therapies and provide physicians and payers with an even deeper understanding of how our bempedoic acid-based products may be used in combination with maximally-tolerated statin therapy. Our goal remains to leverage the bempedoic acid franchise to provide physicians with the flexibility to utilize multiple convenient, cost-effective, once-daily, oral therapies to...


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