- Esperion Therapeutics is making plans to move forward with its clinical program as it tries to push its low density lipoprotein (LDL) cholesterol-lowering treatment to the finish line, despite unclear guidelines for these therapies.
- The company announced Thursday morning it is planning three Phase 3 studies which will be initiated later this quarter. The studies will enroll a slightly different patient population than previously planned, now including patients on any statin at any dose.
- Esperion also announced topline results from aPhase 2 study of bempedoic acid showing the drug plus a statin lowered LDL-C by 22% from baseline compared with patients taking the statin Lipitor (atorvastatin) alone.
Esperion is planning a thorough late-stage program for its LDL-cholesterol drug as it attempts to move forward in an uncertain environment for such treatments.
Both Amgen and Sanofi/Regeneron faced a tough regulatory environment for their PCSK9 inhibitors, which also work by lowering LDL-C, and have experienced pushback from physicians in the marketplace.
There will be three Phase 3 trials: 1002-046, 1002-047 and 1002-048. The first will run as a 12-week study with 300 patients who have hypercholesterolemia with or without atherosclerotic cardiovascular disease (ASCVD) and are only able to tolerate the lowest daily dose level of currently approved statin therapies.
Trial 1002-047 will be another 12-week study in 750 patients with hypocholesteremia with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH) who are not adequately treated with lipid-modifying therapies.
Trial 1002-048 will test the drug in a 12-week study among 250 patients with hypercholesterolemia with or without ASCVD. Patients in this study will be given bempedoic acid plus the statin Zetia (ezetimibe).
A cardiovascular outcomes study was initiated in January of this year with 900 patients. That study has been expanded to 1,950 patients. Results are now expected in mid-2018.
All of these programs will help support a submission of a new drug application to the Food and Drug Administration in the first half of 2019.