FX.co ★ Esperion, Otsuka Say Phase 3 Study Of Bempedoic Acid In Japan Met Primary Goal

Esperion Therapeutics, Inc. (ESPR) and Otsuka Pharmaceutical Co., Ltd announced on Monday that their Phase 3 trial of bempedoic acid in Japan for patients with hypercholesterolemia, or elevated cholesterol levels, successfully achieved its primary objective.

Bempedoic acid, developed by Esperion Therapeutics, is already approved for the treatment of hypercholesterolemia and cardiovascular risk reduction in several regions, including the United States and Europe. In 2020, Otsuka secured exclusive rights to develop and commercialize bempedoic acid in Japan and is currently advancing its development locally.

The primary endpoint of the study, conducted on patients with elevated LDL cholesterol, was the percentage change from baseline in LDL cholesterol at Week 12. Patients treated with bempedoic acid experienced a 25.25% reduction in LDL cholesterol, compared to a 3.46% reduction in those given a placebo.

Moreover, the safety and tolerability profile of bempedoic acid was consistent with previous trials, with no serious adverse events reported.

Otsuka announced plans to submit a New Drug Application in Japan during the second half of 2024.