Esperion (NASDAQ: ESPR) presented positive pooled results from four Phase 3 NEXLETOL trials at the virtual American Heart Association scientific sessions.
NEXLETOL, or bempedoic acid, is a non-statin, low-density lipoprotein cholesterol (LDL-C)-lowering drug that was approved by the FDA earlier this year for the treatment of atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia.
The first analysis demonstrated that a subgroup of more than 580 patients who cannot tolerate statins showed a 26.5% reduction of in LDL-C when taking NEXLETOL, compared with those taking placebo, by week 12.
The second analysis showed that, in a pooled population of more than 3,600 patients, NEXLETOL significantly lowered LDL-C at week 12, compared with placebo. LDL-C lowering was numerically greater in females than in males across both study pools, in both statin-intolerant patients and those receiving background maximally tolerated statins.
“Women are half of the population, and nearly 10-million patients in the U.S. with high LDL-C levels are not on statins due to tolerability issues, yet these groups have been underrepresented in previous medical research,” Ashley Hall, Esperion’s chief development officer, said in a statement.
“Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups,” she added.