Esperion’s bempedoic acid met the primary endpoint in a phase 2 study, in which it was administered to patients already taking a PCSK9 inhibitor to lower their cholesterol.
The eight-week trial involved 58 patients with hypercholesterolemia who received a once daily, 180-mg dose of bempedoic acid or placebo on top of a stable background therapy of Repatha, a PCSK9 blocker from Amgen.
Topline data show the treatment reduced LDL cholesterol levels by 30%, meeting its primary endpoint, the company said. Specifically, patients treated with bempedoic acid had a 27% decrease in LDL levels, while patients who received placebo had a 3% increase in LDL. In addition, the treatment group had a 34% drop in high-sensitivity C-reactive protein (hsCRP), a biomarker of inflammation linked to heart disease, while the placebo group had only a 2% reduction.
“Bempedoic acid has previously demonstrated the ability to complement currently available standard-of-care oral LDL-C lowering therapies, and the results of this Phase 2 study show that bempedoic acid can also be safely and effectively used in patients who require additional LDL-C lowering despite taking an injectable PCSK9 inhibitor,” said Esperion CEO Tim Mayleben. “These Phase 2 results provide consistent evidence and further support that bempedoic acid is poised to become the broadly accessible, complementary, once-daily, oral LDL-C lowering therapy that is appealing to patients, physicians and payers.”
The news comes barely three weeks after the treatment made the grade as a monotherapy in phase 3, where 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.
Esperion has also tested bempedoic acid in combination with statins—it reported in August that a combo of bempedoic acid with the active ingredients in Merck’s Zetia and Pfizer’s Lipitor lowered LDL by 64%, outshining results achieved by a Zetia/Lipitor pairing in other studies. The company expects to file NDAs for bempedoic acid as a standalone therapy and as a combination with Zetia in the first quarter of 2019.