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

Release time：2019.11.27 Views：

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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.

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.

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.

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.

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.