Bempedoic acid: Phase II data
Top-line data from the double-blind, U.S. Phase II 1002-035 trial in 68 patients with hypercholesterolemia on stable background therapy of once-daily 80 mg atorvastatin for 4 weeks showed that once-daily 180 mg oral bempedoic acid as an add-on to atorvastatin for 4 weeks met the primary endpoint of reducing LDL-C from baseline to week 8 vs. placebo plus atorvastatin (reduction of 22% compared to placebo, p=0.0028). Bempedoic acid also met the secondary endpoint of reducing hsCRP levels from baseline to week 8 vs. placebo (reduction of 35% compared to placebo, p=0.002). Bempedoic acid was well tolerated with no serious adverse events reported. Esperion said its Phase III CLEAR program for bempedoic acid will now include patients who are on optimized background lipid-modifying therapy, including maximally tolerated statin therapy. By year end, the company plans to start 3 global Phase III trials of bempedoic acid in hypercholesterolemia patients who are inadequately treated with current lipid-modifying therapies and a cardiovascular outcomes trial (CVOT). Esperion expects top-line data from the Phase III CLEAR program in mid-2018 with regulatory submissions to FDA and EMA following in 1H19. ...