Braintree Laboratories, a part of US-based Sebela Pharmaceuticals and a manufacturer of gastroenterology pharmaceutical products, announced on Wednesday 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).

The company says that across both the erosive esophagitis (EE) and non-erosive reflux disease (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 oesophageal 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 says that it 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.

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.