Sebela Pharma Announces Positive Results from Phase 3 TRIUMpH Programme of Tegoprazan in GERD

"Braintree Laboratories, a part of Sebela Pharmaceuticals and a leading manufacturer of gastroenterology pharmaceutical products, announced positive topline results from two pivotal US phase 3 clinical trials evaluating tegoprazan, a novel potassium-competitive acid blocker (P-CAB), in patients with gastroesophageal reflux disease (GERD).

Across both the EE and NERD pivotal studies known as TRIUMpH, tegoprazan achieved significance in all primary and secondary endpoints tested. This included statistical superiority over a PPI (lansoprazole) in achieving complete esophageal healing at weeks 2 and 8 across all grades of EE, including the significant cohort of patients with severe disease (LA Grades C & D). In the NERD trial, tegoprazan demonstrated complete symptom relief for both heartburn (overnight and heartburn free days) and regurgitation.

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.

The TRIUMpH programme 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 were tested and achieved statistical significance.

The phase 3 NERD study consisted of a large, multicenter, double-blind study (n=800) designed to demonstrate the safety and efficacy of tegoprazan versus placebo.?The primary endpoint for the placebo-controlled treatment phase was the percentage of 24-hour heartburn-free days. Additional key endpoints included percentage of days without overnight heartburn and percentage of days without regurgitation.

Tegoprazan is a novel agent in development for the treatment of acid-related gastrointestinal diseases. It is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have rapid onset of action and the ability to control gastric pH for longer periods of time than proton pump inhibitors (PPIs). Tegoprazan has already received marketing authorization in 19 countries.

GERD is a chronic and highly prevalent disorder affecting approximately 65 million people in the US. It is characterized by a wide variety of symptoms, including heartburn and acid regurgitation. The main phenotypic presentations of GERD include non-erosive reflux disease (NERD) and erosive esophagitis (EE). NERD is defined by reflux-related symptoms without esophageal erosions.  In addition to reflux-related symptoms, EE is defined by erosions in the esophagus caused by acid reflux from the stomach.  While proton pump inhibitors are the mainstay of therapy for both EE and NERD, 35% to 54% of patients fail to achieve complete relief of symptoms, highlighting a significant unmet need in this population.

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health.

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