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Sebela Pharmaceuticals Showcases Phase 3 Results for Tegoprazan at Digestive Disease Week 2026

At the recent Digestive Disease Week (DDW) 2026, Sebela Pharmaceuticals, through Braintree Laboratories, presented compelling Phase 3 clinical trial results evaluating their novel drug, Tegoprazan. This investigational medication is aimed at individuals suffering from erosive esophagitis (EE) and offers a new therapeutic strategy in managing gastroesophageal reflux disease (GERD).

Key Findings from the TRIUMpH-EE Clinical Trial

The clinical program, dubbed TRIUMpH-EE, enrolled 1,245 adult participants with EE across various centers in the United States. Of these, 463 were classified with severe disease (Los Angeles Grade C/D). The objective was to assess Tegoprazan against the established proton pump inhibitor (PPI), Lansoprazole, focusing on both the healing of acute EE and the 24-week maintenance of healing.

The findings revealed that Tegoprazan significantly outperformed Lansoprazole at multiple points during the trial:

1. Healing at Weeks 2 and 8: Tegoprazan achieved a complete healing rate of 84.6% at Week 8 versus Lansoprazole’s 78.0%, marking a statistically significant difference (p=0.0083). Additionally, it was found to be superior in achieving healing at Week 2, 76.4% versus Lansoprazole’s 67.0% (p<0.0001).

2. Maintenance of Healing over 24 Weeks: In the maintenance phase, Tegoprazan demonstrated sustained effectiveness with 69.4% of patients maintaining complete healing at Week 24 compared to Lansoprazole’s 50.6%. A remarkable 76.4% of those with severe EE sustained healing when treated with Tegoprazan (p<0.0001).

3. Heartburn Relief: Tegoprazan was also shown to provide enhanced heartburn relief, particularly in severe EE patients, with a notable difference in the number of 24-hour heartburn-free days compared to Lansoprazole, enhancing patients’ quality of life.

The results underscore Tegoprazan's self-regulating mechanism, which sets it apart from other drugs in the market. Alan Cooke, President and CEO of Sebela Pharmaceuticals, remarked on the potential of Tegoprazan to provide significant advancements in GERD treatment, particularly for patients who are often resistant to standard PPI therapy.

Insights from Presentations at DDW 2026

During two oral sessions at the conference, several notable points were highlighted:

• - Dr. Felice Schnoll-Sussman (Weill Cornell Medicine) discussed the acute healing effects, providing an in-depth analysis of results from the 8-week healing phase.
• - Dr. C. Prakash Gyawali (Washington University School of Medicine) focused on the long-term maintenance potential of Tegoprazan, emphasizing its comparability in safety to Lansoprazole with similar rates of treatment-emergent adverse events.

Both sessions captivated the audience, illustrating the potential for Tegoprazan to change the paradigm in managing erosive esophagitis and related gastric disorders.

About Digestive Disease Week and Future Directions

DDW represents the largest gathering in gastroenterology and brings together healthcare professionals and researchers dedicated to advancing understanding of gastrointestinal disorders. Sebela’s participation marked a significant stride in the conversation around innovative treatments in this field.

As Sebela Pharmaceuticals prepares to submit a New Drug Application (NDA) for Tegoprazan to the FDA, the anticipation grows around its approval, expected in January 2027. The promise shown in the TRIUMpH program not only positions Sebela at the forefront of gastroenterology but also aims to address significant unmet needs within the patient population experiencing chronic reflux diseases.

In summary, the excitement surrounding Tegoprazan's Phase 3 results at DDW 2026 speaks volumes about the drug's potential in delivering better outcomes for patients suffering from erosive esophagitis and related disorders, offering hope for improved management of these challenging conditions.