Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)
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
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
