Bempedoic acid meets goal in Phase III hypercholesterolemia trial

Japanese drugmaker Otsuka (TYO: 4578) has announced that the primary endpoint was achieved in the Phase III trial in Japan of bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically-significant outcomes and highlighted its potential future value of bempedoic acid to patients in Japan.

Bempedoic acid, created by the USA’s Esperion Therapeutics (Nasdaq: ESPR), has a novel mechanism of action that inhibits a cholesterol synthesis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzume in the liver. Bempedoic acid is marketed for the treatment of hypercholesterolemia in several regions around the world, including the United States and Europe.

In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid (tradename Nexletol), in Japan from Esperion and is currently developing it domestically, in a deal potentially worth more than half a billion dollars. Esperion gained US regulatory approval for Nexletol in February 2020.