Sebela’s Novel Potassium-Competitive Acid Blocker Demonstrates Promise in Gastroesophageal Reflux Disease

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Sebela Pharmaceuticals announced that tegoprazan, a novel potassium-competitive acid blocker (P-CAB), achieved statistical superiority over the proton pump inhibitor lansoprazole in two pivotal Phase III TRIUMpH trials treating gastroesophageal reflux disease (GERD). The agent demonstrated significantly higher rates of complete esophageal healing at weeks two and eight in patients with both erosive esophagitis (EE) and non-erosive reflux disease (NERD), including those with severe EE (LA Grades C and D).¹

"We are delighted with tegoprazan's Phase III clinical results. Across both our EE and NERD trials, tegoprazan achieved all primary and secondary endpoints tested,” said Alan Cooke, president, CEO, Sebela Pharmaceuticals, in a press release. “This includes superior EE healing for all patients over lansoprazole at weeks two and eight of treatment. 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."

The multicenter, double-blind EE study compared the safety and efficacy of tegoprazan vs. lansoprazole in 1,250 patients, including 463 with LA Grade C/D esophagitis. The primary endpoint was the percentage of all patients with complete healing by week eight. Secondary endpoints included the percentage of 24-hour heartburn-free days; LA Grade C/D patients with complete healing by week eight; LA Grade C/D patients with complete healing at week two; all patients with complete healing at week eight; and all patients with complete healing at week two.

The second trial in the TRIUMpH program, a multicenter, double-blind study, evaluated the safety and efficacy of tegoprazan in 800 patients with NERD. The primary endpoint was the percentage of 24-hour heartburn-free days during the placebo-controlled treatment phase. Secondary endpoints included the percentage of days without overnight heartburn and the percentage of days without regurgitation.

In the NERD cohort, tegoprazan provided complete symptom relief for both heartburn and regurgitation. Across both studies, the drug met all primary and secondary endpoints, reinforcing its potential as a differentiated treatment option in GERD.

The safety and tolerability of tegoprazan were found to be comparable to lansoprazole and placebo. Treatment-emergent adverse events (TEAEs) occurred in fewer than 3% of patients and were generally mild and short-lived. Serious TEAEs occurred in fewer than 2% of participants, with similar rates across all treatment groups. Additionally, average serum gastrin levels for both tegoprazan and lansoprazole remained within the normal range throughout the treatment periods.¹

"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 Felice Schnoll-Sussman, MD, professor of clinical medicine, Weill Cornell Medical College, director, Jay Monahan Center for Gastrointestinal Health, in the press release.

Sebela also highlighted results from a US-based Phase I pharmacodynamic study, which showed that tegoprazan delivers rapid acid suppression regardless of food intake, achieving a gastric pH above 4 within 45 minutes of administration, underscoring its convenience and clinical distinction.¹

"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.

The maintenance portion of the EE study is expected to finish in Q3 of this year. In Q4, Sebela will submit a New Drug Application that includes both indications.¹

Reference

1. Sebela Pharmaceuticals® Announces Positive Topline Results from Phase 3 TRIUMpH Program of Tegoprazan in GERD. PR Newswire. April 23, 2025. Accessed April 23, 2025. https://prnmedia.prnewswire.com/news-releases/sebela-pharmaceuticals-announces-positive-topline-results-from-phase-3-triumph-program-of-tegoprazan-in-gerd-302435337.html