Esperion Therapeutics Provides Bempedoic Acid Development Program Updates; Reports Third Quarter 2016 Financial Results

ANN ARBOR, Mich., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today provided bempedoic acid (ETC-1002) development program updates and financial results for the third quarter ended September 30, 2016.

"With the delivery of positive top-line results from the clinical studies of bempedoic acid in combination with high-dose statins, we will enroll patients with hypercholesterolemia on maximally tolerated lipid-modifying therapy, including patients on any statin at any dose, into our global pivotal Phase 3 program," said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. "While we continue to rapidly enroll patients into the global long-term safety study, we look forward to initiating the global pivotal Phase 3 LDL-C lowering efficacy studies and cardiovascular outcomes trial for bempedoic acid before year-end. With our available cash resources, we remain focused on delivering top-line results from our Phase 3 efficacy and long-term safety studies by mid-2018."

Development Program and Company Highlights
  • October 2016:
    • Esperion announced positive top-line results of the Phase 1 (1002-037) and Phase 2 (1002-035) clinical studies of bempedoic acid in combination with high-dose statins.
    • Esperion amended and expanded the global Phase 3 CLEAR Harmony (1002-040) 52-week, long-term safety study to include 1,950 patients with hypercholesterolemia on maximally tolerated lipid modifying therapy, including patients on any statin at any dose.
    • Esperion announced high-level design details for three global pivotal Phase 3 CLEAR LDL-C lowering efficacy studies of bempedoic acid - 1002-046, 1002,047, and 1002-048.
    • Esperion announced the proposed global pivotal Phase 3 clinical development plan is expected to support global regulatory submissions for an LDL-cholesterol lowering indication in patients with hypercholesterolemia on maximally tolerated background lipid modifying therapy who require additional LDL-cholesterol lowering, with a special focus on patients considered "statin intolerant".

Upcoming Milestones
  • Q4 2016:
    • Esperion plans to initiate the three global pivotal Phase 3 CLEAR LDL-C lowering efficacy studies and the global CLEAR Outcomes cardiovascular outcomes trial.
    • Esperion plans to publish the definitive scientific paper on the mechanism of action for bempedoic acid in a top-tier journal.

2016 Third Quarter Financial Results

As of September 30, 2016, cash and cash equivalents and investment securities available-for-sale totaled $259.7 million compared with $292.6 million at December 31, 2015.

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