Daewon Pharm has announced promising results for its new gastroesophageal reflux disease (GERD) treatment, Padoprazan (DW4421). The drug demonstrated efficacy comparable to existing therapies in a domestic Phase 3 clinical trial.
The company aims to file for regulatory approval with the Ministry of Food and Drug Safety by year-end, positioning itself to compete in the rapidly expanding domestic potassium-competitive acid blocker (P-CAB) market.
On Thursday, Daewon Pharm revealed that Padoprazan met its primary efficacy endpoint in the Phase 3 trial for patients with erosive reflux disease (ERD). The study established non-inferiority compared to esomeprazole, a widely used proton pump inhibitor (PPI).
The trial, coordinated by Dr. Kim Byung-wook from Incheon St. Mary’s Hospital, involved 328 patients across 22 medical institutions nationwide.
Researchers evaluated three treatment arms: Padoprazan at 20 mg and 40 mg doses, and esomeprazole at 40 mg. The initial treatment period was four weeks, with an extension up to eight weeks for patients whose esophageal mucosal damage had not fully healed.
The primary endpoint was complete healing of esophageal mucosal lesions, confirmed via endoscopy. Analysis of the per-protocol population showed that the 95% confidence interval for the difference in efficacy between the Padoprazan 40 mg group and the control group ranged from -2.50% to 6.87%. For the 20 mg group, the range was -3.90% to 6.58%.
Both Padoprazan doses met the predetermined non-inferiority margin of -10.0%, confirming that the new drug is not clinically less effective than the existing treatment.
Safety data revealed similar adverse event rates across all groups: 4.59% for Padoprazan 40 mg, 3.74% for Padoprazan 20 mg, and 3.70% for esomeprazole. No statistically significant differences were observed between groups, and no serious adverse events were reported.
K-Cab, launched in March 2019 as South Korea’s 30th novel drug, was approved for both erosive and non-erosive GERD indications at its initial release.
K-Cab’s active ingredient, Tegoprazan, belongs to the P-CAB class, which rapidly suppresses gastric acid secretion and can be taken without regard to meals.
Daewon Pharm plans to conduct further analyses based on these Phase 3 results and submit a final report to the Ministry of Food and Drug Safety for product approval by year-end.
The company is also running a Phase 3 trial for non-erosive reflux disease (NERD) patients and preparing clinical studies to expand indications.
Padoprazan, a novel P-CAB candidate, works by competitively inhibiting the proton pump involved in gastric acid secretion. Daewon Pharm received approval for the clinical trial plan last October, enrolled the first patient in November, and completed the last patient’s treatment this September.
Market research firm UBIST projects that annual prescriptions for P-CAB drugs in South Korea will reach 368.6 billion KRW (approximately 276 million USD) by 2025, a 29% increase from the previous year. This year’s figures are expected to surpass 400 billion KRW (about 299 million USD).
A Daewon Pharm spokesperson stated that the Phase 3 trial has validated Padoprazan’s efficacy and safety profile. It’s committed to completing the detailed analyses and regulatory process efficiently to offer GERD patients a new treatment option.