Braintree Laboratories, a part of Sebela Pharmaceuticals, reported results from its Phase 3 TRIUMpH program for tegoprazan in adults with non-erosive reflux disease (NERD), along with a post hoc analysis of erosive esophagitis (EE) data that received an American College of Gastroenterology Presidential Award, the company said in the release announcing the presentations at the ACG 2026 Annual Scientific Meeting.
TRIUMpH-NERD was a randomized, double-blind, placebo-controlled, multicenter study that enrolled 783 adults with symptomatic NERD. Patients received tegoprazan 50 mg, tegoprazan 100 mg or placebo once daily for four weeks, followed by a 20-week extension. The primary endpoint was the percentage of 24-hour heartburn-free days through week 4, with days without nighttime heartburn over the same period as a key secondary endpoint and regurgitation assessed as a prespecified exploratory endpoint.
The company said both doses met the primary and secondary endpoints. Least-squares mean 24-hour heartburn-free days through week 4 were 17.3% with placebo, 26.2% with tegoprazan 50 mg and 30.1% with tegoprazan 100 mg (p=0.0006 and p<0.0001). Days without nighttime heartburn were 27.0%, 36.1% and 39.9%. At Day 28 the rates were 26.7% for placebo, 38.9% for 50 mg and 45.6% for 100 mg. Treatment differences were apparent from Day 1 for heartburn-free days and days without regurgitation. In the open-label extension, heartburn-free days averaged 48% with 50 mg and 50% with 100 mg.
A separate post hoc analysis of TRIUMpH-EE data reclassified baseline EE using the Lyon 2.0 Consensus, treating LA grades B through D as conclusive GERD and LA grade A as inconclusive. Among 415 patients with conclusive GERD, those taking 100 mg of tegoprazan daily showed superior healing at weeks 2 and 8 and maintenance of healing at week 24 compared with lansoprazole, which was taken by 399 patients. In the modified intention-to-treat population of 1,245 patients, healing rates for conclusive GERD were 75.4% versus 60.7% at week 2 (p<0.0001) and 83.4% versus 72.7% cumulatively by week 8 (p=0.0005). No statistically significant differences between groups were observed for inconclusive GERD.
Braintree submitted a New Drug Application to the U.S. Food and Drug Administration in January 2026 seeking approval of tegoprazan for heartburn associated with NERD, the healing of EE and the maintenance of that healing in adults, and said U.S. approval is anticipated in January 2027. Tegoprazan has marketing authorization in 24 countries and is marketed as K-CAB in several regions outside the United States, including South Korea. Across the TRIUMpH program, the company said individual treatment-emergent adverse events occurred at a rate of about 3% and serious events at about 2%, with similar rates between tegoprazan and the active or placebo comparators.
