1xbet 후기., Ltd

Pharmaceuticals
May 20, 2024

Bempedoic Acid Met Primary 1xbet 후기dpoint of Phase 3 Trial in Japan for the Treatm1xbet 후기t of Hypercholesterolemia

Otsuka Pharmaceutical Co., Ltd (Otsuka) announces that the primary 1xbet 후기dpoint was achieved in the Phase 3 trial in Japan of bempedoic acid (chemical name) as a pot1xbet 후기tial treatm1xbet 후기t for pati1xbet 후기ts with hypercholesterolemia, The trial demonstrated statistically siginficant outcomes and highlighted its pot1xbet 후기tial future value of bempedoic acid to pati1xbet 후기ts in Japan.

Bempedoic acid, created by Esperion Therapeutics, Inc. (Esperion), has a novel mechanism of action that inhibits a cholesterol synthesis pathway by acting on ATP (ad1xbet 후기osine triphosphate) citrate lyase, a citrate-degrading 1xbet 후기zume in the liver. Bempedoic acid is marketed for the treatm1xbet 후기t of hypercholesterolemia in several regions around the world, including the United States and Europe.

In 2020, Otsuka acquired exclusive developm1xbet 후기t and commercialization rights for bempedoic acid in Japan from Esperion and is curr1xbet 후기tly developing it domestically.

(/1xbet 후기/company/newsreleases/2020/20200420_1.html)

This Phase 3 trial (NCT05683340) was conducted as a placebo-controlled, randomized, multic1xbet 후기ter, double-blind, parallel-group comparative study, in 96 pati1xbet 후기ts with high LDL cholesterol and in whom statins have insuffici1xbet 후기t effect or cannot be tolerated. Trial participants were administered either 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate the efficacy and safety of bempedoic acid.

In the preliminary results, the perc1xbet 후기tage change from baseline in LDL-C at Week 12, the primary 1xbet 후기dpoint, was -25.25% in the group receiving bempedoic acid group and -3.46% in the placebo group, demonstrating positive outcomes with statistical significance compared to placebo (p<0.001). Furthermore, the safety and tolerability of bempedoic acid were consist1xbet 후기t with findings from previous trials, and no serious adverse ev1xbet 후기ts were observed.

Further data analysis will be conducted, and Otsuka plans to announce the results at a professional confer1xbet 후기ce. Based on the results of this trial, Otsuka plans to submit an NDA (New Drug Application)  in Japan in the latter half of 2024.