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.
Cinclus Pharma signs EUR220m European commercialisation deal with Zentiva for acid reflux therapy
Sanofi to acquire Vigil Neuroscience for USD470m to expand Alzheimer's pipeline
Moderna withdraws application for flu-COVID combination vaccine pending additional efficacy data
Revalesio reports further analysis from Phase 2 RNS60 trial for acute ischemic stroke treatment
AnnJi reports positive Phase 1/2a results in Spinal and Bulbar Muscular Atrophy trial
Sarepta receives UK approval to continue dosing in ELEVIDYS ENVISION study
MSD expands clinical development of Orion's opevesostat to include women's cancers
Promontory Therapeutics reports successful FDA meeting after Phase 2 study of PT-112
Trevi Therapeutics reports additional results from Phase 2a RIVER trial of Haduvio
Accropeutics reports positive data from Phase 2 psoriasis treatment trial
NextCell Pharma partners with Fujifilm Irvine Scientific to deliver integrated MSC solutions
Lifecare files for first human trial of glucose monitoring implant, targeting CE-mark
EXACT Therapeutics reports strong Phase 1 results for ACTIVATE trial in colorectal liver metastases