A seven-day treatment using Daewoong Pharmaceutical's (069620.KS) gastroesophageal reflux disease drug Fexuclue showed no statistically significant difference from the standard 14-day regimen in eradicating Helicobacter pylori, according to a new study. The finding draws attention because it suggests the treatment period could be cut in half.
Daewoong Pharmaceutical said on the 23rd that it had released results of a clinical study comparing the efficacy and safety of a seven-day triple therapy based on Fexuclue (generic name fexuprazan hydrochloride) with a conventional 14-day triple therapy based on proton pump inhibitors (PPIs).
A research team led by Professor Park Sung-chul of the gastroenterology department at Kangwon National University Hospital conducted a randomized, single-center study of 79 Korean patients who had not previously undergone H. pylori eradication treatment. Eradication therapy combines antibiotics with acid-suppressing drugs, and factors such as medication adherence and antibiotic resistance affect the outcome.
Among patients who completed treatment and evaluation, the eradication rate for the seven-day Fexuclue-based therapy was 83.78%, with no statistically significant difference from the 88.89% recorded in the 14-day PPI-based group. In the full analysis set, the Fexuclue group posted an eradication rate of 80.00% and the PPI group 82.05%.
The results were presented at major academic conferences in Korea and abroad and published on Sept. 11 in the international journal Medicine.
"This study was not designed as a non-inferiority trial, but it has clinical significance in that the seven-day Fexuclue-based triple therapy was confirmed to show an eradication rate with no statistically significant difference from the existing 14-day regimen," Park said.
"This study is meaningful in that it confirmed new clinical evidence for the seven-day Fexuclue-based regimen," said Park Hyung-chul, head of Daewoong Pharmaceutical's ETC Marketing Division. "We will continue to accumulate evidence through various clinical studies and push to expand indications."