山东罗欣药业集团股份有限公司招标公告
Luoxin Pharmaceutical: Potassium-competitive Acid Blocker (P-CAB) LXI-15028 Phase III Trial Meets Primary Endpoint
中国上海，2019年12月27日 — 山东罗欣药业集团股份有限公司（以下简称“罗欣药业”）今日宣布，其在研新药钾离子竞争性酸阻滞剂（Potassium-Competitive Acid Blockers, P-CAB）LXI-15028，在一项多中心、随机、双盲、平行分组与艾司奥美拉唑对比治疗中国糜烂性食管炎患者长达8周的III期临床研究中，结果达到主要疗效终点。
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.
该研究纳入了261名成人糜烂性食管炎中国患者，患者按照1:1的比例被随机分配至LXI-15028 50毫克治疗组和艾司奥美拉唑40毫克治疗组，初步分析结果提示LXI-15028治疗8周的累计内镜愈合率非劣于艾司奥美拉唑。罗欣药业将根据计划详细分析该研究的具体数据后择期进行新药申请。
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.
糜烂性食管炎是胃食管反流病的主要类型之一，胃食管反流病以胃酸或胃内食物反流入食管造成典型的烧心症状或其他多种症状为疾病特征，可能导致巴瑞特食管，甚至食管溃疡、食管狭窄或肿瘤等疾病，严重影响患者的生活质量。患者在接受当前标准治疗之后，仍有约10-15%的患者无法达到愈合，并且约30%的患者仍有烧心症状。
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是消化道酸相关性疾病新药研发的重要方向之一，其作用机制是在胃壁细胞分泌胃酸的最后阶段，竞争性地阻断钾离子与质子泵（即氢离子/钾离子——三磷酸腺苷酶，H+/K+-ATP酶）结合，从而对胃酸分泌产生强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的首个III期临床研究结果达到主要疗效终点是罗欣药业药物研发和临床开发的重要里程碑。2015年10月，罗欣药业与CJ Health Care达成协议，获得后者侯选药物LXI-15028中国内地境内开发、生产及商业化权益。
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.
