In its third pivotal trial readout this year, the 180-mg dose of Esperion's LDL cholesterol-lowering treatment, bempedoic acid, hit its primary endpoint in a trial of high-risk patients with atherosclerotic cardiovascular disease (ASCVD). And there is more to come—the company expects to report data from two more studies later this year.
The 24-week trial evaluated the treatment in patients with ASCVD or at high risk for ASCVD with hypercholesterolemia whose cholesterol cannot be controlled with background LDL-lowering drugs and who cannot use statins. The study involved about 4,000 patients already on background lipid-modifying meds, with two-thirds of them receiving a daily dose of bempedoic acid and the remainder receiving placebo.
The treatment lowered LDL cholesterol levels by 26%, compared to the 2% decrease achieved by placebo. The treatment group also had a 25% drop in high-sensitivity C-reactive protein (hsCRP), a biomarker of inflammation linked to heart disease, while the placebo group had only a decrease of 3%.
"The dataset from this study is reassuring and highly consistent with what we’ve seen previously with bempedoic acid. For the millions of patients with hypercholesterolemia who are considered statin intolerant and have limited treatment options, bempedoic acid provides meaningful LDL-cholesterol lowering and statin-like reductions in hsCRP,” said Ulrich Laufs, director of the Department of cardiology at Leipzig University and a member of Esperion’s phase 3 executive committee. “The medical community is in need of a new oral therapy which is effective, well tolerated and convenient for this complex patient population who may have run out of other options.”
In March, bempedoic acid put up positive phase 3 results as a monotherapy—it lowered LDL levels 23% from baseline, compared to a 5% increase observed in patients on placebo. The trial involved 269 patients with atherosclerosis, or patients who are at high risk of atherosclerosis whose cholesterol cannot be controlled with lipid-modifying drugs, such as Merck’s Zetia, or the lowest approved starting dose of a statin.
And a few weeks later, the company announced positive data from a phase 2 trial of bempedoic acid as an add-on treatment for patients already taking Repatha, a PCSK9 inhibitor from Amgen, to lower their cholesterol. Topline data showed that patients treated with bempedoic acid had a 27% decrease in LDL levels, while patients who received placebo had a 3% increase in LDL.
Up next? Data from a pair of trials evaluating bempedoic acid alone and in a combination.
“We eagerly anticipate the pivotal Phase 3 study results for our lead product candidate, the bempedoic acid/ezetimibe combination pill, in late August, and the fourth and final pivotal phase 3 study of bempedoic acid, Study 2, in late September. Both studies include ASCVD patients on maximally tolerated statin therapy," said Esperion CEO Tim Mayleben.