Daewoong Pharmaceutical said Friday that its potassium-competitive acid blocker (P-CAB) drug Fexuclue (fexuprazan HCl) demonstrated non-inferior eradication efficacy and comparable safety to conventional proton pump inhibitor (PPI)-based standard therapy in a phase 3 clinical trial for first-line eradication treatment of Helicobacter pylori.
Based on the phase 3 results, the company also received approval from the Ministry of Food and Drug Safety for an additional indication for Fexuclue 40 mg for H. pylori eradication therapy.
With the new approval, Fexuclue has expanded its treatment scope beyond existing indications, including treatment of erosive gastroesophageal reflux disease (GERD), improvement of gastric mucosal lesions in acute and chronic gastritis, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers, to include H. pylori eradication therapy.
A Daewoong Pharmaceutical clinical researcher (right) explains the study results of Fexuclue to a physician at an overseas event. (Courtesy of Daewoong Pharmaceutical)
The multicenter, randomized, double-blind phase 3 trial was designed to demonstrate non-inferiority and evaluate safety compared with conventional therapy. Researchers enrolled 461 patients who received either fexuprazan 40 mg or lansoprazole 30 mg in combination with two antibiotics -- amoxicillin and clarithromycin -- for 14 days as part of triple therapy, followed by assessment of eradication outcomes.
According to detailed data, Fexuclue showed particularly notable efficacy in patients with clarithromycin-resistant strains. In this subgroup, the Fexuclue-based regimen achieved an eradication rate of 54.76 percent, compared with 28.57 percent for the lansoprazole-based control regimen, representing an approximately 26-percentage-point higher success rate and demonstrating statistical superiority (p=0.0112).
Daewoong Pharmaceutical explained that the findings may suggest that Fexuclue’s gastric acid-suppressive properties positively influenced the efficacy of antibiotic treatment.
In the primary efficacy analysis involving all participants, the Fexuclue group achieved an eradication rate of 83.64 percent, confirming non-inferiority compared with 77.93 percent in the control group. The company said the study demonstrated both efficacy comparable to standard treatment and differentiated effectiveness in antibiotic-resistant patients, a population in which eradication success rates are generally lower.
The incidence of adverse events did not differ significantly between the two groups, and the overall safety profiles were similar.
Professor Jung Hwoon-yong, who led the study at Asan Medical Center, said, “This study confirmed the efficacy and safety of Fexuclue-based therapy compared with conventional treatment in first-line Helicobacter pylori eradication therapy. In particular, the higher eradication rate observed in clarithromycin-resistant patients is highly meaningful in terms of expanding treatment options in real-world clinical practice.”
Nah Jae-jin, head of the Clinical Medicine Center at Daewoong Pharmaceutical, said, “This study is meaningful in that it not only showed eradication efficacy comparable to existing standard therapies, but also confirmed the potential for Fexuclue to serve as a new treatment option in clinical settings where antibiotic resistance is making eradication therapy increasingly difficult. We will continue to focus our efforts on expanding Fexuclue’s indications and providing patients with new treatment options.”
(Caption)
Daewoong Pharmaceutical’s Osong plant in North Chungcheong Province (Courtesy of Daewoong Pharmaceutical)
Kim Ji-hye
댓글
0