Esperion Therapeutics/Otsuka Partnered Cholesterol Drug Shows Effective In Japan Study
Esperion Therapeutics/Otsuka Partnered Cholesterol Drug Shows Effective In Japan Study
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.
週一，Esperion Therapeutics（納斯達克股票代碼：ESPR）和大冢製藥有限公司宣佈，日本本培多酸治療高膽固醇血癥的3期試驗的主要終點已經達到。
The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan.
該試驗顯示了本培多酸的主要終點具有統計學意義的結果，並強調了其對日本患者的潛在未來價值。
Related: Heart Disease Drugmaker Esperion Therapeutics Reports Highest Revenue Yet, Stock Soars.
相關： 心臟病製藥商Esperion Therapeutics公佈了迄今爲止最高的收入，股價飆升。
The Phase 3 trial was conducted in 96 patients with high LDL cholesterol and in whom satins have insufficient effect or cannot be tolerated.
3期試驗在96名低密度脂蛋白膽固醇高且他汀類藥物作用不足或無法耐受的患者中進行。
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).
在初步結果中，作爲主要終點的第12周低密度脂蛋白C與基線相比的百分比變化百分比在接受本培多酸安慰劑組中爲-25.25％，安慰劑組爲-3.46％，顯示出與安慰劑相比具有統計學意義的積極結果（p
Furthermore, the safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed.
此外，本培多酸的安全性和耐受性與先前試驗的結果一致，未觀察到嚴重的不良事件。
Based on the results of this trial, Otsuka plans to submit a New Drug Application (NDA) in Japan in the latter half of 2024.
根據這項試驗的結果，大冢計劃於2024年下半年在日本提交新藥申請（NDA）。
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.
由Esperion Therapeutics創造的本培多酸通過作用於肝臟中的檸檬酸降解酶ATP（三磷酸腺苷）檸檬酸裂解酶來抑制膽固醇合成途徑。
Bempedoic acid is marketed for hypercholesterolemia and cardiovascular risk reduction in several regions, including the U.S. and Europe.
本培多酸在包括美國和歐洲在內的多個地區上市，用於高膽固醇血癥和降低心血管風險。
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.
上週二，Esperion宣佈，美國專利商標局頒發了本美多酸的美國專利期延期證書，該物質包含在NEXLETOL（本培多酸）片劑和NEXLIZET（本培多酸和依澤替米貝）片劑中。
The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030.
該證書將美國7,335,799號專利的期限延長了五年，至2030年12月3日。
In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is developing it domestically.
2020年，大冢從Esperion手中獲得了本培多酸在日本的獨家開發和商業化權，並正在國內進行開發。
Price Action: ESPR shares are up 5.51% at $2.49 at last check Monday.
價格走勢：週一最後一次檢查時，ESPR股價上漲5.51％，至2.49美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。