Daewoong Pharmaceutical has released the results of a study on the indication of its P-CAB (potassium-competitive acid blockers)-based drug, Fexuclue (fexuprazan hydrochloride), to treat gastritis at the United European Gastroenterology Week (UEGW) 2022.
Daewoong said it unveiled the phase 3 clinical trial data of Fexuclue in acute or chronic gastritis patients at the UEGW 2022 in Vienna on Tuesday.
According to Daewoong, in the efficacy evaluation index of “effective rate of gastric mucosal erosion on upper gastrointestinal endoscopy,” Fexuclue proved superior to place in both 20mg tablets once a day (59/102 people, 57.8 percent) and 10mg tablets twice a day (67/102 people). In addition, there was no statistically significant difference compared to placebo as a result of safety assessment, such as adverse drug reactions, and no significant adverse drug reactions.
“Just as the PPIs (proton pump inhibitors) replaced the conventional gastric acid secretion inhibitor, the H2 blocker, in 1990, the P-CAB will replace the PPI soon, and Fexuclue, a P-CAB drug recently developed by Daewoong Pharmaceutical, will play a leading role in this trend,” said Professor Kim Kwang-ha of the Department of Gastroenterology at Pusan National University Hospital and the study’s lead author.
Kim noted that the existing PPI was developed in the West, and treatment indications were determined from a Western perspective. However, Fexuclue, developed in Korea, has received indications from the beginning of its release for not only reflux esophagitis but gastritis, common among Koreans, according to the Korean treatment environment. So, it is expected to be of great help to patients and clinicians who prescribe actual drugs, he added.
In particular, Fexuclue is the only P-CAB formulation in Korea to add gastritis indication. Aside from treating erosive gastroesophageal reflux disease and improving gastric mucosal lesions in acute and chronic gastritis, the company is stepping up research to expand Fexuclue’s indications.
For example, it has conducted phase 3 clinical trials to prevent gastroduodenal ulcers caused by nonsteroidal anti-inflammatory analgesics (NSAIDs) and another phase 3 trial for the maintenance therapy for patients cured of erosive gastroesophageal reflux disease. It is also preparing for clinical trials for eradicating helicobacter bacteria.
“Releasing the study results of Fexuclue's indication to treat gastritis at UEGW 2022 was an opportunity to promote the excellence of Fexuclue to medical professionals worldwide,” Daewoong Pharmaceutical CEO Lee Chang-he said. “Daewoong plans various clinical trials at home and abroad to add a follow-up indication of Fexuclue. In addition, we will focus on strengthening our product capabilities by expanding our lineups for ease of use."