Sebela Pharmaceuticals has announced positive topline results from its Phase 3 TRIUMpH clinical program evaluating tegoprazan, a novel potassium-competitive acid blocker (P-CAB), for the treatment of gastroesophageal reflux disease (GERD). The trials demonstrated tegoprazan's superior efficacy compared to proton pump inhibitor (PPI) therapy, potentially offering a new treatment option for the approximately 65 million Americans suffering from GERD.
The TRIUMpH program consisted of two pivotal Phase 3 studies conducted entirely in the United States, representing the demographically diverse US population. Both studies met all primary and secondary endpoints, showing tegoprazan's effectiveness in treating both erosive esophagitis (EE) and non-erosive reflux disease (NERD).
Superior Healing in Erosive Esophagitis
In the large, multi-center, double-blind EE study involving 1,250 patients (including 463 with severe LA Grade C/D esophagitis), tegoprazan demonstrated statistical superiority over lansoprazole, a standard PPI therapy. The drug achieved complete esophageal healing at significantly higher rates at both week 2 and week 8 across all grades of disease severity.
"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," said Dr. Felice Schnoll-Sussman, Professor of Clinical Medicine at Weill Cornell Medical College and Director of the Jay Monahan Center for Gastrointestinal Health.
The primary endpoint for the EE healing phase was the percentage of all patients with complete healing by week 8. Secondary endpoints included the percentage of 24-hour heartburn-free days, healing rates in patients with severe disease (LA Grade C/D), and healing rates at week 2. All pre-specified efficacy endpoints were tested and achieved statistical significance.
Significant Symptom Relief in Non-Erosive Reflux Disease
The Phase 3 NERD study, a multicenter, double-blind trial involving 800 patients, compared tegoprazan to placebo. The primary endpoint was the percentage of 24-hour heartburn-free days during the treatment phase. Tegoprazan demonstrated complete symptom relief for both heartburn (including overnight heartburn) and regurgitation.
Dr. Prateek Sharma, Professor at the University of Kansas School of Medicine and current President of the American Society of Gastrointestinal Endoscopy, highlighted a key advantage: "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."
Rapid Onset and Favorable Safety Profile
A US-based Phase 1 pharmacodynamic study demonstrated that tegoprazan provides more rapid acid control (pH>4) within 45 minutes of administration and works regardless of food intake, offering patients a truly differentiated therapeutic option compared to conventional PPIs.
The safety profile of tegoprazan was comparable to both lansoprazole and placebo across the studies. Individual treatment-emergent adverse events occurred at a rate of less than 3% and were generally mild and transient. The overall rate of serious treatment-emergent adverse events in each study was less than 2% and similar between treatment groups. Importantly, mean serum gastrin levels for both tegoprazan and lansoprazole remained within the normal range (0-180 pg/ml) throughout the relevant treatment periods.
Addressing Unmet Needs in GERD Treatment
GERD affects approximately 65 million people in the US and is characterized by symptoms including heartburn and acid regurgitation. While PPIs are the current standard of care, studies show that 35% to 54% of patients fail to achieve complete symptom relief, highlighting a significant unmet need.
"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."
Regulatory Timeline
The maintenance phase of the EE study is expected to complete in Q3 2025, with a New Drug Application inclusive of both the EE and NERD indications planned for filing with the FDA in Q4 2025. Sebela intends to submit results from the TRIUMpH Phase 3 studies to a high-impact, peer-reviewed journal and present the data at a leading gastroenterology conference.
Tegoprazan has already received marketing authorization in 19 countries worldwide, and these positive Phase 3 results position it as a potential new treatment option for US patients with GERD who are not adequately controlled on current therapies.
