#United States #GERD #Braintree #Sebela Pharmaceuticals #Tegoprazan

Sebela Pharmaceuticals' Breakthrough in GERD Treatment

Sebela Pharmaceuticals®, through its subsidiary Braintree Laboratories, has achieved significant milestones in the field of gastroenterology with its latest drug, Tegoprazan. Recently, the company announced the successful completion of the 24-week maintenance phase of the Phase 3 TRIUMpH clinical program. This trial focused on assessing the efficacy of Tegoprazan for patients suffering from gastroesophageal reflux disease (GERD), particularly those with erosive esophagitis (EE).

Trial Highlights

During the trial, patients who had previously reached complete healing in an initial 8-week phase were assigned to a 24-week maintenance treatment. They were given either Tegoprazan at doses of 100mg or 50mg, or a standard dose of lansoprazole at 15mg. Notably, both Tegoprazan doses not only matched the effectiveness of lansoprazole but surpassed it for maintaining healing across all grades of erosive esophagitis. This was especially evident in the most severe cases (LA Grades C/D), where Tegoprazan 100mg achieved statistical superiority in maintenance outcomes.

In terms of symptom relief, the study also showed that both dosages of Tegoprazan provided a similar frequency of 24-hour heartburn-free days compared to lansoprazole, a finding consistent with previous trial results. This multi-faceted efficacy makes Tegoprazan a compelling candidate in the ongoing battle against GERD, a condition that afflicts approximately 65 million people in the U.S.

Safety and Tolerability

The safety profile of Tegoprazan in this trial was reassuring, demonstrating low rates of treatment-emergent adverse events (TEAEs) and no new safety signals reported. The mean serum gastrin levels remained stable and well within normal limits throughout the trial phases, further enhancing the drug's profile as a safe alternative for GERD patients.

Upcoming Regulatory Steps

Sebela Pharmaceuticals is gearing up for a New Drug Application (NDA) submission to the FDA in the fourth quarter of 2025, targeting both EE and non-erosive reflux disease (NERD). This follows earlier announcements of favorable outcomes from the healing phase of the TRIUMpH study, which underscored Tegoprazan's effectiveness in providing sustained relief from GERD-related symptoms.

Expert Insights

Alan Cooke, President, and CEO of Sebela Pharmaceuticals, expressed enthusiasm about the implications of the study results, emphasizing the potential for Tegoprazan to redefine long-term therapeutic strategies for GERD. The drug's capacity to deliver effective healing while maintaining a favorable safety profile sets it apart from existing treatments.

Dr. Prakash Gyawali, a renowned expert in gastroenterology, affirmed the benefits highlighted by the trial results. He remarked on the sustained clinical value of Tegoprazan, particularly in severe cases, further supporting its role as a vital new tool for improving patient outcomes.

Conclusion

The TRIUMpH program's findings mark a promising step toward innovative therapeutic options for individuals grappling with GERD. As Sebela Pharmaceuticals prepares for its FDA filing, both healthcare providers and patients alike await the next developments regarding Tegoprazan. The potential to enhance the quality of life for millions suffering from gastroesophageal reflux disease is indeed a exciting prospect, highlighting the importance of continuous innovation in medicine and patient care.