Esperion’s bempedoic acid meets primary endpoint in hypercholesterolemia

Esperion and Otsuka Pharmaceutical announced that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid. Bempedoic acid, created by Esperion, has a novel mechanism of action that inhibits a cholesterol synthesis pathway by acting on ATP citrate lyase, a citrate-degrading enzyme in the liver. Bempedoic acid is marketed for the treatment of hypercholesterolemia and cardiovascular risk reduction in several regions of the world, including the U.S. and Europe. In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is currently developing it domestically. In the preliminary results, the percentage change from baseline in LDL-C at Week 12, the primary endpoint, was -25.25%% in the group receiving bempedoic acid placebo group and -3.46% in the placebo group, demonstrating positive outcomes with statistical significance compared to placebo. Safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed. Otsuka plans to submit an New Drug Application in Japan in the latter half of 2024.