Monday, Esperion Therapeutics (NASDAQ:ESPR) and Otsuka Pharmaceutical Co Ltd announced that the primary endpoint in the Phase 3 trial in Japan for bempedoic acid for hypercholesterolemia was achieved.
The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan.
Related: Heart Disease Drugmaker Esperion Therapeutics Reports Highest Revenue Yet, Stock Soars.
The Phase 3 trial was conducted in 96 patients with high LDL cholesterol and in whom satins have insufficient effect or cannot be tolerated.
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 (p<0.01).
Furthermore, the safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed.
Based on the results of this trial, Otsuka plans to submit a New Drug Application (NDA) in Japan in the latter half of 2024.
Bempedoic acid, created by Esperion Therapeutics, inhibits a cholesterol synthesis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzyme in the liver.
Bempedoic acid is marketed for hypercholesterolemia and cardiovascular risk reduction in several regions, including the U.S. and Europe.
Last Tuesday, Esperion announced that the U.S. Patent and Trademark Office issued a U.S. Patent Term Extension certificate for bempedoic acid, which is contained in NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets.
The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030.
In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is developing it domestically.
Price Action: ESPR shares are up 5.51% at $2.49 at last check Monday.
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