Braintree Laboratories, a part of US-based Sebela Pharmaceuticals and a manufacturer of gastroenterology pharmaceutical products, announced on Thursday 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 erosive esophagitis (EE) who achieved complete healing were randomised to maintenance treatment with tegoprazan 100mg, tegoprazan 50mg, or lansoprazole 15mg for 24 weeks. According to the company, 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.

The safety profile was favourable, 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 (