HK inno.N's K-CAB posts positive Phase 3 results for non-erosive reflux disease at US gastroenterology conference

HK inno.N's gastroesophageal reflux disease drug K-CAB — active ingredient tegoprazan — has demonstrated efficacy in non-erosive disease through a large-scale US Phase 3 trial, strengthening the clinical evidence base for its potential prescription use in the American market.

HK inno.N announced Monday that its US partner Sebela Pharmaceuticals will present results from the Phase 3 trial of K-CAB for non-erosive gastroesophageal reflux disease, or NERD, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2026), being held in Tennessee from Friday through Wednesday (local time).

The presentation, based on the pivotal Phase 3 program known as TRIUMpH-NERD, will be delivered Wednesday (local time) by Ronnie Fass, a gastroesophageal reflux disease specialist and professor at Case Western Reserve University School of Medicine.

The trial enrolled 783 adult patients in the United States, who received tegoprazan 50 mg, tegoprazan 100 mg, or a placebo once daily for four weeks, followed by a 20-week extension period.

Both doses met the primary endpoint — the proportion of 24-hour heartburn-free days through week four — as well as the secondary endpoint of nighttime heartburn-free days. At week four, the proportion of 24-hour symptom-free days was 26.2 percent in the 50 mg group and 30.1 percent in the 100 mg group, compared with 17.3 percent in the placebo group, a statistically significant difference (p=0.0006 and p<0.0001, respectively).

The proportion of nighttime heartburn-free days also exceeded the placebo group, at 36.1 percent for the 50 mg group and 39.9 percent for the 100 mg group versus 27.0 percent for placebo. On a composite symptom index combining heartburn and acid regurgitation, tegoprazan showed relative improvement rates of 60 percent at 50 mg and 76 percent at 100 mg compared with placebo. These effects were sustained throughout the 20-week extension period.

The conference also featured a post-hoc analysis that reclassified Phase 3 erosive esophagitis data under the Lyon Consensus 2.0 criteria, which received the ACG Presidential Poster Award. According to the analysis by Walter Chan, a professor at Harvard Medical School, tegoprazan achieved a week-two healing rate of 75.4 percent in patients with definitive gastroesophageal reflux disease, surpassing the 60.7 percent rate seen with lansoprazole, an existing treatment. Tegoprazan also showed a statistically significant advantage in the week-24 maintenance rate.

Tegoprazan is South Korea's 30th domestically developed new drug and belongs to the potassium-competitive acid blocker, or P-CAB, class. Since its domestic launch in March 2019, it has accumulated outpatient prescription sales of 1.04 trillion won ($779 million) through the first half of this year. Sebela filed a new drug application with the US Food and Drug Administration in January and the review is under way.

The latest clinical presentation is significant because K-CAB has now demonstrated, through a prospective Phase 3 trial, that it can improve core symptoms not only in erosive disease but also in non-erosive gastroesophageal reflux disease — a condition that accounts for a large share of patients — providing key clinical evidence to support FDA approval and broader prescription use in the United States.