HK inno.N Corp.'s K-CAB improves heartburn and acid reflux in U.S. Phase 3 trial

[Financial News] HK inno.N Corp.'s new gastroesophageal reflux disease drug K-CAB improved heartburn and acid reflux symptoms in a U.S. Phase 3 trial. The study, involving 783 U.S. adult patients, met all key assessment criteria, and the treatment effect was maintained during an additional 20-week observation period.
HK inno.N Corp. said on the 12th that its U.S. partner, Sebela Pharmaceuticals, would present the results of the Phase 3 trial in non-erosive gastroesophageal reflux disease at the American College of Gastroenterology's annual scientific meeting (ACG 2026).
Non-erosive gastroesophageal reflux disease is a condition in which stomach acid flows back into the esophagus, causing symptoms such as heartburn, but endoscopy does not show clear damage to the esophageal lining.
A total of 783 U.S. adults took part in the trial. For four weeks, patients took either 50 mg or 100 mg of tegoprazan, the active ingredient in K-CAB, or a placebo, once daily.
Through week 4, the proportion of days with no heartburn over a 24-hour period was 17.3% in the placebo group, compared with 26.2% in the 50 mg tegoprazan group and 30.1% in the 100 mg group. The proportion of days without nighttime heartburn also increased, from 27.0% in the placebo group to 36.1% in the 50 mg group and 39.9% in the 100 mg group. Both doses showed statistically significant differences versus placebo.
The proportion of days without either heartburn or acid reflux also improved. The relative improvement compared with placebo was 60% in the 50 mg tegoprazan group and 76% in the 100 mg group. During the subsequent 20-week extension observation period, the proportions of days without heartburn were 48% and 50%, respectively.
The meeting will also release additional analyses of previously reported Phase 3 data on erosive esophagitis. A post hoc analysis applying the international diagnostic criteria known as the Lyon Consensus 2.0 received the American College of Gastroenterology Presidential Award. Erosive esophagitis refers to damage to the esophageal lining caused by acid reflux.
In that analysis, the healing rate at week 2 of treatment among patients with conclusive gastroesophageal reflux disease was 75.4% in the tegoprazan group, higher than the 60.7% in the lansoprazole group. At week 24, the maintenance-of-healing rate was also higher in both the 50 mg and 100 mg tegoprazan groups than in the lansoprazole group.
Tegoprazan is a new drug developed by HK inno.N Corp. in the potassium-competitive acid blocker (P-CAB) class. Its brand name is K-CAB, and its U.S. partner Sebela submitted a new drug application to the U.S. Food and Drug Administration (FDA) in January this year.
HK inno.N Corp. plans to continue working with its partner toward entering the U.S. market, based on the results of this trial.

[email protected] Jeong Sang-hee Reporter