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

An Exciting Breakthrough in GERD Treatment: Tegoprazan

Sebela Pharmaceuticals recently disclosed promising topline results from the Phase 3 TRIUMpH program focusing on Tegoprazan, a novel medication aimed at treating gastroesophageal reflux disease (GERD). These pivotal trials have shown that Tegoprazan not only acts faster but is also more effective than traditional proton pump inhibitors (PPIs), such as lansoprazole. This development brings a sense of hope to the millions struggling with GERD, a condition that affects approximately 65 million people in the United States alone.

Significant Findings from the TRIUMpH Program

The TRIUMpH studies evaluated the efficacy of Tegoprazan in two specific forms of GERD: erosive esophagitis (EE) and non-erosive reflux disease (NERD). The results revealed that Tegoprazan met all primary and secondary endpoints, demonstrating statistical superiority over lansoprazole in achieving complete esophageal healing within 2 and 8 weeks. This is particularly noteworthy for those diagnosed with severe erosive esophagitis, categorized as LA Grades C and D.

In the NERD trial, subjects reported significant improvements in both 24-hour and overnight heartburn, along with a reduction in regurgitation compared to those receiving a placebo. The safety profile of Tegoprazan was comparable to that of lansoprazole, and both drugs kept mean serum gastrin levels within normal parameters throughout the treatment period.

Statements from Key Figures

Alan Cooke, President and CEO of Sebela Pharmaceuticals, expressed enthusiasm regarding the Phase 3 results. He stated, “Tegoprazan’s performance in the trials is a testament to our commitment over the past four decades to addressing the unmet needs of patients living with gastrointestinal diseases. We are excited to provide a new treatment option that has the potential to greatly improve patient outcomes.”

Adding to this, Dr. Felice Schnoll-Sussman, a professor of Clinical Medicine at Weill Cornell Medical College and director of the Jay Monahan Center for Gastrointestinal Health, noted the superior performance of Tegoprazan over traditional PPIs, stating, “The data suggests that the P-CAB class can outperform PPIs and offers potential advantages.”

Prateek Sharma, MD, President of the American Society of Gastrointestinal Endoscopy, emphasized that heartburn and regurgitation are the main symptoms of GERD, and Tegoprazan’s ability to show a measurable reduction in regurgitation highlights its superiority over previous therapies.

Future Developments

Sebela Pharmaceuticals is moving forward, with the maintenance phase of the EE study slated for completion by Q3 2025. A New Drug Application encompassing both EE and NERD indications is expected to be submitted to the FDA in Q4 2025. Additionally, the company plans to publish the TRIUMpH Phase 3 results in a prominent peer-reviewed journal and present the findings at a leading gastroenterology conference in the near future, aiming to share this groundbreaking data with the wider medical community.

About Tegoprazan

Tegoprazan represents a new class of medications known as potassium-competitive acid blockers (P-CABs). These innovative agents are recognized for their rapid onset of action and prolonged gastric pH control, which distinguishes them from the traditional PPIs that have dominated GERD treatment for years. With marketing authorization already granted in 19 countries, Tegoprazan is poised to significantly impact global treatment strategies for acid-related gastrointestinal diseases.

Conclusion

The introduction of Tegoprazan could mark a pivotal moment in how GERD is treated, providing patients with a powerful new option that demonstrates faster relief and a higher effectiveness rate than existing therapies. As Sebela Pharmaceuticals prepares for the next steps, the medical community eagerly anticipates the potential for improved patient outcomes in the realm of gastroenterology.