Sebela Pharmaceuticals announced positive topline results from the 24-week maintenance phase of its pivotal Phase 3 TRIUMpH clinical program evaluating tegoprazan, a novel potassium-competitive acid blocker (P-CAB), in gastroesophageal reflux disease (GERD). The study demonstrated that tegoprazan achieved statistically superior maintenance of healing compared to lansoprazole across all patients with erosive esophagitis, including those with the most severe disease.
Superior Efficacy Across Disease Severity
Following an initial healing phase of up to 8 weeks, patients with erosive esophagitis who achieved complete healing were randomized to maintenance treatment with tegoprazan 100mg, tegoprazan 50mg, or lansoprazole 15mg for 24 weeks. 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. In the most severe erosive esophagitis patients (LA Grade C/D), both doses demonstrated meaningful improvement over lansoprazole 15mg for maintenance of healing at 24 weeks, with tegoprazan 100mg showing statistical superiority.
Both tegoprazan doses also achieved non-inferiority versus lansoprazole in the proportion of 24-hour heartburn-free days over the study period, similar to what was achieved in the previously reported 8-week phase 3 studies in erosive esophagitis healing. In the 4-week NERD trial, both doses of tegoprazan demonstrated superiority over placebo for heartburn, regurgitation and overnight heartburn, the cardinal symptoms of GERD.
Favorable Safety Profile
The safety profile was favorable, with low rates of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs). No new safety signals were identified. Individual treatment-emergent adverse events occurred at a rate of less than 3% in the TRIUMpH studies and were generally mild and transient. Individual serious TEAEs occurred at a rate of less than 1%.
Mean serum gastrin levels remained below the upper limit of normal (less than 180 Ng/L) at all timepoints for both tegoprazan doses. The rates of TEAEs and serious TEAEs in each study were similar between tegoprazan and the PPI and placebo comparator groups.
Comprehensive Clinical Program
The TRIUMpH program comprises two Phase 3 studies of tegoprazan in US patients with GERD, including erosive esophagitis and non-erosive reflux disease (NERD). The Phase 3 studies were conducted entirely in the US and are representative of the demographically diverse US population.
The Phase 3 erosive esophagitis study (NCT05587309) consisted of a large, multi-center, double-blind study (n=1,250, including 463 patients with LA Grade C/D esophagitis) evaluating the safety and efficacy of tegoprazan versus lansoprazole. The Phase 3 NERD study (NCT05587322) consisted of a large, multicenter, double-blind study (n=800) designed to demonstrate the safety and efficacy of tegoprazan versus placebo.
Clinical Impact and Regulatory Timeline
"These results reinforce the potential of tegoprazan to redefine long-term management of GERD," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "We are excited that tegoprazan not only delivers superior and sustained healing across the full spectrum of erosive esophagitis, including more challenging severe cases, but also provides durable control of heartburn with a safety profile comparable to existing therapies."
Dr. Prakash Gyawali, Professor of Medicine and Director of the Neurogastroenterology and Motility Program at Washington University, added, "These maintenance data establish the sustained clinical value of tegoprazan in GERD, even in the most severe categories of erosive esophagitis. Overall, these findings support the promise of tegoprazan as an important new tool to improve lives of GERD patients by providing healing and symptom relief."
Sebela Pharmaceuticals plans to file both erosive esophagitis and NERD indications with FDA in Q4 2025. Results from the TRIUMpH Phase 3 studies will be submitted to high impact, peer reviewed journals along with presentation of this data at leading gastroenterology conferences in the future.
Addressing Unmet Medical Need
GERD is a chronic and highly prevalent disorder affecting approximately 65 million people in the US. While proton pump inhibitors are the mainstay of therapy for both erosive esophagitis and NERD, 35% to 54% of patients fail to achieve complete relief of symptoms, highlighting a significant unmet need in this population.
Tegoprazan is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have rapid onset of action, the ability to control gastric pH for longer periods of time than proton pump inhibitors and superior efficacy in sustained healing of erosive esophagitis, including in the most severe patients. Tegoprazan has already received marketing authorization in 21 countries.
