Introduction: X842 is a new type of gastric acid-suppressing agent with a rapid onset of action and a long duration of effect. We aim to investigate the efficacy and safety of different doses of X842 versus lansoprazole in the treatment of patients with erosive esophagitis (EE).
Methods: This phase 2 study included 90 patients with EE (Los Angeles grades A-D) who were randomized (1:1:1) to receive oral low-dose X842 (50 mg/day, n=31), high-dose X842 (100 mg/day, n=31), or lansoprazole (30 mg/day, n=30) for 4 weeks. The main efficacy endpoint was the EE healing rate, which was the proportion of patients who achieved endoscopic healing after 4 weeks of treatment.
Results: For ITT analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 79.3% (23/29), and 80.0% (24/30) for the X842 50 mg, the X842 100 mg and the lansoprazole 30 mg groups. For PP analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 80.8% (21/26), and 82.1% (23/28) in the three groups, respectively. The EE healing rate did not significantly differ among the three groups in either the ITT (p = 0.2351) or PP (p = 0.3320) analysis. The incidence of drug-related treatment-emergent adverse events (TEAEs) did not differ among groups. No severe drug-related TEAEs occurred in the X842 group.
Conclusions: Our findings confirmed that X842 had efficacy and a favourable safety profile similar to those of lansoprazole. Therefore, X842, a novel P-CAB, is expected to become a promising therapeutic agent for EE.
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http://dx.doi.org/10.14309/ctg.0000000000000803 | DOI Listing |
Clin Transl Gastroenterol
January 2025
Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing Digestive Disease Center, Beijing 100050, China.
Introduction: X842 is a new type of gastric acid-suppressing agent with a rapid onset of action and a long duration of effect. We aim to investigate the efficacy and safety of different doses of X842 versus lansoprazole in the treatment of patients with erosive esophagitis (EE).
Methods: This phase 2 study included 90 patients with EE (Los Angeles grades A-D) who were randomized (1:1:1) to receive oral low-dose X842 (50 mg/day, n=31), high-dose X842 (100 mg/day, n=31), or lansoprazole (30 mg/day, n=30) for 4 weeks.
J Pharm Biomed Anal
May 2024
School of Chinese Materia Medica, Nanjing University of Chinese Medicine, Nanjing 210023, China; Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201210, China. Electronic address:
Linaprazan (AZD0865, TX07) is one of potassium-competitive acid blockers. However, linaprazan is rapidly excreted from the body, shortening its acid inhibition property. Linaprazan glurate (X842) is a prodrug of linaprazan with a prolonged inhibitory effect on gastric acid secretion.
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