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Esperion (ESPR) Stock Gains On Strong Phase II Data



8/8/2017 8:33:06 AM

Esperion Therapeutics Stock Gains On Strong Phase II Data August 8, 2017
By Alex Keown, BioSpace.com Breaking News Staff

ANN ARBOR, Mich. – Shares of Esperion Therapeutics, Inc. (ESPR) have climbed more than 19 percent this morning after the company announced its Phase II combination cholesterol treatment showed tremendous success in lowering low density lipoprotein cholesterol levels in patients.


In its announcement this morning, Esperion said its bempedoic acid combination as a component of triplet oral therapy in patients with high cholesterol (hypercholesterolemia) met its primary endpoint in lowering LDL levels. The combination of bempedoic acid and ezetimibe plus atorvastatin was able to lower LDL-C levels by 50 percent or more in 95 percent of the patients receiving treatment. Ninety percent of patients saw a lowering of LDL-C levels by 70 percent, the company said. Additionally, the combination treatment demonstrated a 48 percent reduction in high-sensitivity C-reactive protein (hsCRP), which is an important marker of the underlying inflammation associated with cardiovascular disease.

Bempedoic acid is a first-in-class ATP Citrate Lyase (ACL) inhibitor. Bempedoic acid reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Early and mid-stage trial data presented by Esperion has shown the bempedoic acid has produced clinically relevant LDL-C lowering results of up to 30 percent as monotherapy and an incremental 20+ percent when added to stable statin therapy.

“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," Tim Mayleben, president and chief executive officer of Esperion, said in a statement. “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 treat the vast majority of patients with elevated LDL-C.”
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Not only did the combination treatment demonstrate efficacy in lowering LDL levels in patients, the drug appears to be relatively safe. During the Phase II trial there were no serious adverse events reported. Additionally, there was 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. There were also no elevations reported in liver function tests.

The positive Phase II news comes on the heels of June news when the U.S. Food and Drug Administration confirmed the abbreviated regulatory pathway to approval for the bempedoic acid / ezetimibe combination pill for an LDL-C lowering indication. A Phase III bridging study is expected to be initiated in the fourth quarter of 2017 and complete by the end of 2018 to support an NDA submission for an LDL-C lowering indication.

In July, the company announced the design of a Phase II study of bempedoic acid added-on to a PCSK9i.

Shares of Esperion are trading at $53.73 as of 11:15 a.m. The stock closed at $45.17 on Aug. 7.


Read at BioSpace.com


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