Daewoong Pharmaceutical said Wednesday that its potassium-competitive acid blocker (P-CAB) Fexuclue outperformed esomeprazole, a widely used proton pump inhibitor (PPI), in treating erosive gastroesophageal reflux disease (GERD).

The combined analysis results from phase 3 studies involving 513 patients in Korea and China were presented at the United European Gastroenterology Week (UEGW 2024), Europe's largest gastroenterology conference, held in Vienna from last Saturday to this Tuesday.

The study found that Fexuclue achieved a 98 percent cure rate for erosive GERD—a condition where stomach acid flows back into the esophagus, potentially causing discomfort and tissue damage—after eight weeks of treatment. 

Fexuclue also showed greater improvement in primary symptom relief compared to esomeprazole, particularly in the early stages of treatment. During the first three days, 20.4 percent of patients taking Fexuclue reported symptom-free days and nights, compared to 11.9 percent of those on esomeprazole, indicating a 71.4 percent higher rate of symptom relief.

The drug also demonstrated statistically significant improvement in reducing nighttime symptoms of GERD. Among patients with moderate-to-severe GERD, 32 percent of those taking Fexuclue experienced symptom-free nights during the first three days, compared to 22 percent of those on esomeprazole, marking a 45.4 percent improvement.

According to Daewoong Pharmaceutical, Fexuclue—a drug developed over 13 years to overcome the limitations of traditional proton pump inhibitors—boasts a rapid and consistent ability to inhibit stomach acid secretion. Its meal-independent dosing and long half-life of nine hours enhance its effectiveness, especially in easing nighttime symptoms.

While the study found that Fexuclue’s cure rate for erosive GERD is comparable to esomeprazole at around 98 percent, Dr. Kim Gwang-ha, a gastroenterologist at Pusan National University Hospital, noted that its “superior symptom relief, both day and night,” sets it apart.

The results stem from a pooled analysis of two phase 3 studies conducted in Korea and China, which evaluated cure rates and the proportion of symptom-free days and nights among 513 GERD patients. A subgroup analysis underscored its effectiveness in moderate to severe cases, demonstrating improvements in heartburn and acid reflux symptoms within the first seven days of treatment.

“It is significant that we have laid the foundation for securing meaningful data on East Asian populations by integrating the results of the phase 3 clinical trials conducted in Korea and China,” said Choi Jong-won, executive director of the development division at Daewoong Pharmaceutical, adding that the company will "continue to secure differentiated data and expand indications to develop Fexuclue into a global blockbuster."