羅欣藥業(yè)發(fā)布鉀離子競(jìng)爭(zhēng)性酸阻滯劑LXI-15028臨床III期研究進(jìn)展

發(fā)布時(shí)間：2019年11月27日 瀏覽次數(shù)：

分享：

Luoxin Pharmaceutical: Potassium-competitive Acid Blocker (P-CAB) LXI-15028 Phase III Trial Meets Primary Endpoint

中國(guó)上海，2019年12月27日 — 山東羅欣藥業(yè)集團(tuán)股份有限公司（以下簡(jiǎn)稱“羅欣藥業(yè)”）今日宣布，其在研新藥鉀離子競(jìng)爭(zhēng)性酸阻滯劑（Potassium-Competitive Acid Blockers, P-CAB）LXI-15028，在一項(xiàng)多中心、隨機(jī)、雙盲、平行分組與艾司奧美拉唑?qū)Ρ戎委熤袊?guó)糜爛性食管炎患者長(zhǎng)達(dá)8周的III期臨床研究中，結(jié)果達(dá)到主要療效終點(diǎn)。

Shanghai, China, December 27, 2019- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (“Luoxin Pharmaceutical”) announced today， the innovative investigational product, potassium-competitive acid blocker (P-CAB), has met the primary endpoint in the multi-center, randomized, double-blind, parallel-group controlled phase III study to evaluate the efficacy and safety of LXI-15028 for the patients with erosive esophagitis during up to 8-week treatment, compared to Esomeprazole.

該研究納入了261名成人糜爛性食管炎中國(guó)患者，患者按照1:1的比例被隨機(jī)分配至LXI-15028 50毫克治療組和艾司奧美拉唑40毫克治療組，初步分析結(jié)果提示LXI-15028治療8周的累計(jì)內(nèi)鏡愈合率非劣于艾司奧美拉唑。羅欣藥業(yè)將根據(jù)計(jì)劃詳細(xì)分析該研究的具體數(shù)據(jù)后擇期進(jìn)行新藥申請(qǐng)。

The study enrolled 261 Chinese adult patients with erosive esophagitis, who were randomized into LXI-15028 (50 mg) and Esomeprazole (40 mg) treatment arms in a 1:1 ratio. Topline data suggested the cumulative healing rate of LXI-15028 arm during up to 8-week treatment as assessed by endoscopy is non-inferior to that of Esomeprazole arm. As the next step, Luoxin Pharmaceutical will further analyze the full data followed by the new drug application.

糜爛性食管炎是胃食管反流病的主要類型之一，胃食管反流病以胃酸或胃內(nèi)食物反流入食管造成典型的燒心癥狀或其他多種癥狀為疾病特征，可能導(dǎo)致巴瑞特食管，甚至食管潰瘍、食管狹窄或腫瘤等疾病，嚴(yán)重影響患者的生活質(zhì)量。患者在接受當(dāng)前標(biāo)準(zhǔn)治療之后，仍有約10-15%的患者無(wú)法達(dá)到愈合，并且約30%的患者仍有燒心癥狀。

Erosive esophagitis is the main subtype of gastroesophageal reflux disease (GERD), which is characterized by regurgitation, heartburn or other symptoms, possibly leading to Barrett esophagitis, esophageal ulcer, esophageal stenosis, or gastrointestinal tumors, with significant impact on patient’s quality of life. According to the data from literature, approximately 10-15% of patients cannot achieve clinical healing and 30% of patients remain with the residual symptoms of heartburn after receiving the current standard of care.

P-CAB是消化道酸相關(guān)性疾病新藥研發(fā)的重要方向之一，其作用機(jī)制是在胃壁細(xì)胞分泌胃酸的最后階段，競(jìng)爭(zhēng)性地阻斷鉀離子與質(zhì)子泵（即氫離子/鉀離子——三磷酸腺苷酶，H+/K+-ATP酶）結(jié)合，從而對(duì)胃酸分泌產(chǎn)生強(qiáng)大而持久的抑制效果。

Potassium-competitive acid blocker (P-CAB) represents one of the drug development advances for acid-related gastrointestinal disorders. P-CAB competitively inhibits the binding of potassium ions to the proton pump (namely the H⁺/K⁺-ATPase) during the final stages of gastric acid secretion in gastric parietal cells, thus producing a strong and sustained inhibitory effect on gastric acid secretion.

LXI-15028的首個(gè)III期臨床研究結(jié)果達(dá)到主要療效終點(diǎn)是羅欣藥業(yè)藥物研發(fā)和臨床開發(fā)的重要里程碑。2015年10月，羅欣藥業(yè)與CJ Health Care達(dá)成協(xié)議，獲得后者侯選藥物L(fēng)XI-15028中國(guó)內(nèi)地境內(nèi)開發(fā)、生產(chǎn)及商業(yè)化權(quán)益。

The first phase III study of LXI-15028 meeting its primary endpoint constitutes a key milestone in Luoxin Pharmaceutical’s research and development. Luoxin Pharmaceutical entered into an agreement with CJ HealthCare in October 2015, which granted Luoxin Pharmaceutical an exclusive right to develop, manufacture and commercialize the candidate LXI-15028 in China.