Tegoprazan demonstrated statistically superior maintenance of healing in all patients across all grades (LA Grades A–D) of erosive esophagitis (EE) and in the most severe patients (LA Grades C/D) versus lansoprazole 15mg.Safety and tolerability continued to be similar to lansoprazole and mean serum gastrin levels remained within normal limits throughout the maintenance phase (New Drug Application (NDA) to be filed with FDA for both EE and NERD in Q4 2025.BRAINTREE, Mass., Aug. 7, 2025 /PRNewswire/ -- Braintree Laboratories, a part of Sebela Pharmaceuticals® and a leading manufacturer of gastroenterology pharmaceutical products, today announced positive topline results from the 24-week maintenance phase of the pivotal Phase 3 TRIUMpH clinical program evaluating tegoprazan, a novel potassium-competitive acid blocker (P-CAB), in gastroesophageal reflux disease (GERD). Following an initial healing phase of up to 8 weeks, patients with EE who achieved complete healing were randomized to maintenance treatment with tegoprazan 100mg, tegoprazan 50mg, or lansoprazole 15mg for 24 weeks. The study met its primary endpoint, with both tegoprazan doses achieving non-inferiority to lansoprazole for the percentage of all patients (LA Grades A–D) with sustained healing at 24 weeks. Notably, both tegoprazan 100mg and 50mg were also statistically superior to lansoprazole 15mg for maintenance of healing in this population.In the most severe EE patients (LA Grade C/D), both doses demonstrated meaningful improvement over lansoprazole 15mg for maintenance of healing at 24 weeks, with tegoprazan 100mg showing statistical superiority. Both tegoprazan doses also achieved non-inferiority versus lansoprazole in the proportion of 24-hour heartburn-free days over the study period, similar to what was achieved in the previously reported 8-week phase 3 studies in EE healing. In the 4-week NERD trial, both doses of tegoprazan demonstrated superiority over placebo for heartburn, regurgitation and overnight heartburn, the cardinal symptoms of GERD.The safety profile was favorable, with low rates of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs). No new safety signals were identified. Mean serum gastrin levels remained below the upper limit of normal (Earlier this year, Sebela Pharmaceuticals announced positive top-line GERD results for tegoprazan in NERD as well as the healing phase of the TRIUMpH EE study where it achieved statistically significant results across all endpoints related to EE healing and symptom resolution.Sebela Pharmaceuticals plans to file both EE and NERD indications with FDA in Q4 2025. Results from the TRIUMpH Phase 3 studies will be submitted to high impact, peer reviewed journals along with presentation of this data at leading gastroenterology conferences in the future."These results reinforce the potential of tegoprazan to redefine long-term management of GERD," said Alan Cooke, President and CEO of ...Full story available on Benzinga.com
Sebela Pharmaceuticals® Announces Successful Completion of Phase 3 TRIUMpH Program of Tegoprazan in GERD with Positive 24-Week Maintenance Phase Results
