HK inno.N said on the 12th that its U.S. partner, Sebela Pharmaceuticals, will present results from a U.S. Phase 3 trial of K-CAB (tegoprazan), a treatment for gastroesophageal reflux disease (GERD), in patients with non-erosive reflux disease (NERD) at the American College of Gastroenterology’s annual scientific meeting, ACG 2026.
The meeting will take place in Tennessee from the 9th to the 14th, and the clinical results will be presented on the 14th by Ronnie Fass, a professor at Case Western Reserve University School of Medicine.
Non-erosive reflux disease is a condition in which patients experience symptoms such as heartburn or acid reflux, but endoscopic examination reveals no clear damage to the esophageal lining.
The Phase 3 trial, TRIUMpH-NERD, enrolled 783 U.S. adults. Participants received tegoprazan at doses of 50 mg or 100 mg, or a placebo, once daily for four weeks, followed by an additional 20 weeks of observation to assess its effects.
The results showed that both doses of tegoprazan met the primary and secondary endpoints. The primary endpoint was the percentage of 24-hour periods without heartburn, while the secondary endpoint was the percentage of nights without heartburn.
By Week 4, the percentage of days without heartburn over a 24-hour period was 17.3% in the placebo group, 26.2% in the 50 mg tegoprazan group and 30.1% in the 100 mg group. The percentages of nights without heartburn were 27.0%, 36.1% and 39.9%, respectively, with both tegoprazan doses showing statistically significant improvements over placebo.
The percentage of days without either heartburn or acid regurgitation also improved. On the composite symptom endpoint, the 50 mg and 100 mg groups showed relative improvements of 60% and 76%, respectively, compared with placebo. Symptom improvements persisted throughout the 20-week extension period.
At the same meeting, a reanalysis of U.S. Phase 3 data for tegoprazan in erosive esophagitis received the American College of Gastroenterology President’s Award. Applying Lyon Consensus 2.0, an international diagnostic framework for GERD, the study found that the healing rate at Week 2 among patients with conclusive GERD was 75.4% in the tegoprazan group, compared with 60.7% in the lansoprazole group, which received an established treatment.
“This presentation is significant because it allows us to share the clinical value of K-CAB, demonstrated in a large U.S. patient population, at an international gastroenterology conference,” an HK inno.N representative said. “We will continue working closely with our partner to strengthen K-CAB’s position in the world’s largest pharmaceutical market.”
K-CAB is the 30th new drug developed in South Korea and belongs to the potassium-competitive acid blocker (P-CAB) class. It recorded cumulative domestic outpatient prescription sales of 1.0433 trillion won through the first half of this year. HK inno.N has signed technology-export or finished-product export agreements covering 55 countries. In the United States, it submitted a new drug application to the FDA in January.
