Shots:
- TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25
- In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing non-inferiority & superiority to lansoprazole (15mg) in maintaining healing at 24wks., incl. in cases of LA Grade C/D
- In sev. EE (LA Grade C/D), both doses improved healing at 24wks., with 100mg statistically superior; also, both doses matched lansoprazole in 24hr. heartburn relief, plus showed superiority over PBO for heartburn, regurgitation & overnight heartburn in NERD study
Ref: PRNewsWire| Image: Sebela Pharmaceuticals| Press Release
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