ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq: ESPR), the Ann Arbor-based pharmaceutical developer, announced positive results from the final Phase 3 test of its lead drug candidate, bempedoic acid.
The company said a global, pivotal Phase 3 clinical study (Study 1002-047) showed that a dose of 180 milligrams per day of the drug showed additional lowering of LDL-C, the so-called bad cholesterol, in patients who could not tolerate a higher dose of today’s statin drugs due to their side effects.
The drug also reduced biomarkers for inflammation while producing fewer cardiac side effects than placebo. There was also a lowering of HbA1c in patients with diabetes.
This trial was a 52-week, randomized, double-blind, placebo-controlled study that included 779 high cardiovascular risk patients taking maximally tolerated statins who required additional LDL-C lowering.
“This is the final clinical study from our global, pivotal Phase 3 LDL-C lowering program for bempedoic acid. We are now one step closer to being able to provide convenient, cost-effective and complementary LDL-C lowering therapies for use by patients who require additional LDL-C lowering,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We express our sincere thanks to all of the clinical trial investigators, site coordinators and patients in this study for their dedication in helping us complete the clinical development of bempedoic acid for patient with hyperlipidemia.”
Esperion plans to submit New Drug Applications to the U.S. Food and Drug Administration for bempedoic acid and a bempedoic acid-ezetimibe combination pill for LDL-C-lowering indications during the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency during the second quarter of 2019.
Esperion’s overall Phase 3 testing of bempedoic acid included four studies involving 3,621 high cardiovascular risk patients, all of whom had experienced side effects of statin drugs.
In Phase 1 trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 trials, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. And in Phase 3, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
To listen to a replay of a conference call discussing these studies, visit http://investor.esperion.com.