山東羅欣藥業集團股份有限公司招標公告
Luoxin Pharmaceutical: Potassium-competitive Acid Blocker (P-CAB) LXI-15028 Phase III Trial Meets Primary Endpoint
中國上海，2019年12月27日 — 山東羅欣藥業集團股份有限公司（以下簡稱“羅欣藥業”）今日宣布，其在研新藥鉀離子競爭性酸阻滯劑（Potassium-Competitive Acid Blockers, P-CAB）LXI-15028，在一項多中心、隨機、雙盲、平行分組與艾司奧美拉唑對比治療中國糜爛性食管炎患者長達8周的III期臨床研究中，結果達到主要療效終點。
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患者，患者按照1:1的比例被隨機分配至LXI-15028 50毫克治療組和艾司奧美拉唑40毫克治療組，初步分析結果提示LXI-15028治療8周的累計內鏡愈合率非劣于艾司奧美拉唑。羅欣藥業將根據計劃詳細分析該研究的具體數據后擇期進行新藥申請。
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，可能導致巴瑞特食管，甚至食管潰瘍、食管狹窄或腫瘤等疾病，嚴重影響患者的生活質量。患者在接受當前標準治療之后，仍有約10-15%的患者無法達到愈合，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是消化道酸相關性疾病新藥研發的重要方向之一，其作用機制是在胃壁細胞分泌胃酸的最后階段，競爭性地阻斷鉀離子與質子泵（即氫離子/鉀離子——三磷酸腺苷酶，H+/K+-ATP酶）結合，從而對胃酸分泌產生強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III期臨床研究結果達到主要療效終點是羅欣藥業藥物研發和臨床開發的重要里程碑。2015年10月，羅欣藥業與CJ Health Care達成協議，獲得后者侯選藥物LXI-15028中國內地境內開發、生產及商業化權益。
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.
