Daewoong's 'Pexuclu', 71% More Effective Than Existing Drugs... Korea-China Clinical Analysis

Daewoong Pharmaceutical announced on the 16th that an analysis of 513 patients with erosive gastroesophageal reflux disease (GERD) in Korea and China confirmed that Daewoong Pharmaceutical's new drug for GERD treatment, Pexuclu, demonstrated superior efficacy compared to the previously used drug esomeprazole. The results of this Korea-China integrated analysis were presented at the United European Gastroenterology Week (UEGW 2024) held in Vienna, Austria, from the 12th to the 15th (local time).

Daewoong Pharmaceutical's gastroesophageal reflux disease treatment 'Pexuclu'
Photo by Daewoong Pharmaceutical

Gastroesophageal reflux disease is a condition in which stomach acid or contents flow back into the esophagus, causing uncomfortable symptoms or tissue damage. It mainly presents symptoms such as 'heartburn' and 'acid reflux.' Heartburn refers to a burning sensation that extends from behind the breastbone to the throat, and acid reflux refers to stomach acid or food from the stomach rising between the esophagus and larynx.

The analysis showed that Pexuclu's treatment rate for erosive GERD was 98.0% at 8 weeks, demonstrating excellent efficacy. The primary symptom relief rate indicator also showed that Pexuclu had statistically significant symptom improvement compared to esomeprazole, a proton pump inhibitor (PPI) class drug used in existing treatments. Notably, the difference in symptom improvement was clear from the early treatment period, between days 1 and 3. During the early treatment phase, the proportion of days without major daytime and nighttime symptoms was 20.4% in the Pexuclu group and 11.9% in the esomeprazole group. Accordingly, Pexuclu's symptom relief rate was found to be 71.4% higher than that of esomeprazole.

Additionally, Pexuclu showed statistically significant superiority in improving symptoms caused by nighttime acid secretion. Among patients with moderate or higher severity, the proportion of days without major nighttime symptoms from days 1 to 3 was 32.0% in the Pexuclu group and 22.0% in the esomeprazole group, indicating that Pexuclu's symptom relief rate was 45.4% better than esomeprazole. The company explained that "Pexuclu has a half-life of up to 9 hours, which likely contributed to the prolonged duration of its effect."

This integrated analysis study combined the phase 3 clinical trial results of erosive GERD conducted separately in Korea and China, evaluating the treatment rate of erosive GERD and the proportion of days without major daytime and nighttime symptoms in 513 GERD patients. Additionally, a subgroup analysis was conducted on patients with moderate or higher severity to assess the proportion of days without the main symptoms of heartburn and acid reflux during days 1 to 7 of treatment.

Pexuclu is a potassium-competitive acid blocker (P-CAB) formulation launched by Daewoong Pharmaceutical in July 2022. It improves upon the drawbacks of existing PPI treatments, such as slow onset of action and dietary influences, by rapidly and stably suppressing stomach acid secretion. With a half-life of 9 hours, it is effective in relieving nighttime heartburn symptoms and has the advantage of being taken at any time regardless of meals.

Professor Kim Kwang-ha of the Department of Gastroenterology at Pusan National University Hospital, who participated in the study, said, “This integrated analysis of the Korea-China phase 3 clinical trials confirmed that Pexuclu’s treatment rate for erosive GERD was comparable to esomeprazole at 98%, showing similar efficacy. Particularly, the study is significant as it demonstrated statistical significance in symptom improvement indicators, with Pexuclu showing superior relief of major symptoms both day and night compared to esomeprazole.”