A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients with Erosive Esophagitis.

Abstract

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.