Phase 2 study with cholesterol biosynthesis inhibitor on top of PCSK9 inhibitor meets primary endpointNews - Mar. 27, 2018
Patients with hypercholesterolemia treated with bempedoic acid added to the PCSK9 inhibitor evolocumab had an additional LDL-c lowering of 30% compared to placebo and evolocumab (P<0.001) after eight weeks. Also, a significant reduction of 34% in high-sensitivity CRP (hsCRP) was observed in the bempedoic acid-treated group compared to placebo (P<0.029).
In this phase 2 study, bempedoic acid was shown to be safe and well-tolerated.
Bempedoic acid is a first-in-class, complementary, orally available, once-daily ATP Citrate Lyase inhibitor that reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Similar to statins, bempedoic acid also reduces hsCRP, a key marker of inflammation associated with CVD.
The trial was designed as a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of bempedoic acid 180 mg/day in patients with hypercholesterolemia (LDL-c ≥160 mg/dL) who received evolocumab 420 mg administered every four weeks. A total of 59 patients were randomized in a 1:1 ratio to receive bempedoic acid or placebo added on to evolocumab. The primary endpoint was the LDL-c lowering efficacy of bempedoic acid vs. placebo in patients on evolocumab.
"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 Tim M. Mayleben, president and chief executive officer of Esperion.