Tegoprazan Shows Superior Efficacy and Safety in Treating Esophageal Conditions in Phase 3 trial

The maintenance phase of the EE study will complete in Q3 2025 with a New Drug Application inclusive of both the EE and NERD indications planned for filing with FDA in Q4 2025. Braintree® intends to submit results from the TRIUMpH Phase 3 studies to a high impact, peer reviewed journal along with presentation of this data at a leading gastroenterology conference in the future.

"We are delighted with tegoprazan's Phase 3 clinical results. Across both our EE and NERD trials, tegoprazan achieved all primary and secondary endpoints tested. This includes superior EE healing for all patients over lansoprazole at weeks 2 and 8 of treatment" said Alan Cooke, President and CEO of Sebela Pharmaceuticals®. "For over 40 years we have been committed to the gastroenterology therapeutic area and to patients affected by GI diseases. Tegoprazan offers an exciting new treatment option for individuals suffering from GERD, helping to address the substantial unmet need of patients not well-controlled by conventional PPI therapy."

Felice Schnoll-Sussman, MD, Professor of Clinical Medicine at Weill Cornell Medical College®, Director of the Jay Monahan Center for Gastrointestinal Health, commented, "The data for tegoprazan for erosive esophagitis proves that the P-CAB class can outperform PPIs and suggests that tegoprazan may offer advantages over other agents."

"Both heartburn and regurgitation are the cardinal symptoms of GERD, but we only typically talk about heartburn resolution. Probably because previous studies on medical therapies have not been able to show or measure reduction in regurgitation like the P-CAB tegoprazan," said Prateek Sharma, MD, Professor at the University of Kansas School of Medicine, Current President of the American Society of Gastrointestinal Endoscopy®.

In addition, a US-based Phase 1 pharmacodynamic study has demonstrated that tegoprazan can provide more rapid acid control (pH>4) within 45 minutes, with no food effect, offering patients a truly differentiated therapeutic option.

Individual treatment-emergent adverse events occurred at a rate of < 3% in the TRIUMpH studies and were generally mild and transient. The overall rate of serious treatment-emergent adverse events in each study was < 2% and similar between tegoprazan and the PPI and placebo comparator groups. Mean serum gastrin for tegoprazan and lansoprazole remained within the normal range (0-180 pg/ml) throughout the relevant treatment periods in the TRIUMpH studies.

About TRIUMpH

The TRIUMpH program comprises two Phase 3 studies of tegoprazan in US patients with gastroesophageal reflux disease (GERD), including erosive esophagitis (EE) and non-erosive reflux disease (NERD). The Phase 3 studies were conducted entirely in the US and are representative of the demographically diverse US population.

The Phase 3 EE study consisted of a large, multi-center, double-blind study (n=1,250, including 463 patients with LA Grade C/D esophagitis) evaluating the safety and efficacy of tegoprazan versus lansoprazole for indications including the healing of all grades of EE, maintenance of EE healing and relief of heartburn.

The primary and secondary efficacy endpoints in the EE healing phase were hierarchically structured, with secondary endpoint testing commencing and continuing only if the preceding endpoints were statistically significant. All pre-specified efficacy endpoints (Table 1) were tested and achieved statistical significance.