Recently Completed Studies of BEMPEDOIC ACID
Esperion announced positive top-line results on July 28, 2015 from 1002-014, a Phase 2, exploratory safety study, parallel dose clinical study that evaluated the LDL-C lowering efficacy of bempedoic acid monotherapy versus placebo in patients with both hypercholesterolemia and hypertension who were treated for six weeks. Secondary objectives included the assessment of the effect of bempedoic acid on blood pressure, other lipid and cardiometabolic biomarkers, including hsCRP, and characterizing the tolerability and safety of bempedoic acid.
Positive top-line results from 1002-009, a robust, parallel dose Phase 2b clinical study to further evaluate the potential of bempedoic acid to provide incremental LDL-C lowering for patients already taking a statin and not at their LDL-C goal, were announced on March 17, 2015. Patients received one of two dose strengths of bempedoic acid (120 mg/day and 180 mg/day) or placebo as an add-on to atorvastatin, simvastatin, rosuvastatin or pravastatin to evaluate the tolerability, efficacy and safety of bempedoic acid versus placebo in patients with hypercholesterolemia receiving ongoing statin therapy. Top-line results from this study showed the 12-week study met its primary endpoint of greater LDL-C lowering from baseline with bempedoic acid compared with placebo. Bempedoic acid treated patients achieved 17 and 24 percent incremental reductions in LDL-C at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone.
Esperion has studied bempedoic acid in 10 completed studies, including three Phase 1 studies, four Phase 2a studies, two Phase 2b studies, and one exploratory Phase 2 study. Learn more.
Planned Studies of BEMPEDOIC ACID
Esperion launched its global Phase 3 development program, Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen (CLEAR), with the initiation of a long-term safety and tolerability study (1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. Top-line results are expected in the fourth quarter of 2017.
Esperion also initiated a Phase 2 pharmacokinetics/pharmacodynamics study (1002-035) of bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin. Top-line results are expected in the third quarter of 2016. Additionally, the Company has initiated a Phase 1 clinical pharmacology study (1002-037), an open label, pharmacokinetics study to assess safety and tolerability of bempedoic acid on single doses of the highest-doses and most commonly prescribed statins. Top-line results are also expected in the third quarter of 2016.
Final details regarding the CLEAR Phase 3 global clinical and regulatory development plan of bempedoic acid in statin intolerant patients will be announced by the end of the second quarter of 2016. Details of the planned cardiovascular outcomes trial (CVOT) for bempedoic acid in statin intolerant patients will be announced in the third quarter of 2016.