HK inno.N's (195940.KS) gastroesophageal reflux disease drug K-CAB improved heartburn and acid reflux symptoms in a late-stage U.S. trial, raising expectations for its entry into the American market as a new drug application sits with the U.S. Food and Drug Administration.
HK inno.N said on the 12th that its U.S. partner, Sebela Pharmaceuticals, will present Phase 3 results for K-CAB (tegoprazan) in non-erosive reflux disease at the American College of Gastroenterology annual meeting (ACG 2026), which opens on the 14th in Tennessee.
Non-erosive reflux disease involves heartburn and regurgitation caused by stomach acid flowing back into the esophagus, without visible damage to the esophageal lining on endoscopy.
The trial enrolled 783 adult patients in the United States. Participants received either 50 milligrams or 100 milligrams of K-CAB, or a placebo, once daily for four weeks, and symptom improvement was compared across the groups.
Both doses met the primary endpoints. The share of days free of heartburn throughout the day over the four-week period was 17.3% in the placebo group, compared with 26.2% for the 50-milligram group and 30.1% for the 100-milligram group.
The share of nights free of heartburn was also higher for K-CAB, at 36.1% for the 50-milligram dose and 39.9% for the 100-milligram dose, against 27.0% for placebo. Acid reflux symptoms improved as well, and the treatment effect was maintained through a 20-week extension study.
At the same meeting, a further analysis of Phase 3 results for K-CAB in erosive esophagitis is set to receive the American College of Gastroenterology's presidential award. Erosive esophagitis is a condition in which acid reflux causes actual damage to the esophageal lining.
In that analysis, among patients classified as having confirmed gastroesophageal reflux disease, the esophagitis healing rate at week two was 75.4% for K-CAB and 60.7% for lansoprazole, an existing treatment. In a subgroup with milder esophageal damage, however, no statistically significant difference was found between the two drugs.
K-CAB, developed by HK inno.N, is South Korea's 30th domestically developed new drug and belongs to the P-CAB, or potassium-competitive acid blocker, class of acid-suppressing treatments. Since its domestic launch in 2019, it has recorded cumulative outpatient prescriptions of 1.0433 trillion won (about $730 million) through the first half of this year.
The company has signed licensing or finished-product export deals covering 55 countries and has won approval in 24 countries, including South Korea. Sebela filed the new drug application with the FDA in January.
"It is significant that we confirmed K-CAB's clinical value in a large U.S. patient population," an HK inno.N official said. "We will work with our partner to strengthen K-CAB's position in the U.S. market."