Shots:
- TRIUMpH program consists of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE) & non-erosive reflux disease (NERD); EE’s maintenance phase to end by Q3’25, with FDA’s NDA filing for both EE & NERD planned in Q4’25
- EE study (vs lansoprazole) in 1250 pts (incl. 463 with LA Grade C/D) assessed EE healing phases as 1 & 2EPs while NERD study (vs PBO) in 800 pts evaluated % of 24hr. heartburn-free days as 1EP & % of days without overnight heartburn or regurgitation as 2EPs
- Both trials met their 1 & 2EPs, with EE trial showing esophageal healing at Wks. 2 & 8 across all EE grades, plus NERD depicting complete symptom relief for both heartburn & regurgitation
Ref: Prnewswire | Image: Sebela Pharmaceuticals
Related News:- BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
