CJ HealthCare is seeking to add an indication for the eradication of Helicobacter pylori to K-Cab Tab. (tegoprazan), a treatment for gastroesophageal reflux disease (GORD). Helicobacter pylori are a type of bacteria, causing ulcers in the digestive tract.
The Ministry of Food and Safety said it has approved the drugmaker to conduct a phase-1 trial regarding the indication.
In the study, the company will evaluate the pharmacokinetic interactions of the tegoprazan, metronidazole, tetracycline, and bismuth in repeated oral doses in 32 healthy subjects.
K-Cab is Korea’s 30thh novel drug that won the license in July as a treatment for GORD. It became the first potassium-competitive acid blocker (P-CAB) to obtain the indication for erosive and non-erosive GORD.
While conventional treatments such as proton pump inhibitors (PPI) need three to five days to show efficacy, P-CAB drugs suppress gastric acid secretion within one hour after taking the medication. P-CAB treatments also suppress excessive secretion of gastric acid during night time, which could reduce chest pain and a sleep disorder, according to CJ HealthCare.
Besides the indication for GORD, the company has been planning to add an indication for the eradication of Helicobacter pylori.
In February, the company won the nod for a phase-3 trial on triple therapy, including tegoprazan in Helicobacter pylori-positive patients.
On Tuesday, it obtained the green light for another phase-3 study to test quadruple therapy including tegoprazan.
According to the guidelines for diagnosis and treatment of Helicobacter pylori infection in Koreans, revised in 2013, the first-line treatment to eradicate the bacteria is a triple therapy using PPI, amoxicillin, and clarithromycin.
In the case of suspected clarithromycin resistance or a failed triple therapy, a patient can try a bismuth-based quadruple therapy using PPI, metronidazole, bismuth, and tetracycline.
If the quadruple therapy fails, physicians can prescribe more than two antibiotics that were not used in the first-line treatment. To get rid of Helicobacter pylori, it is crucial to maintain PH level above 6 in the stomach.
When CJ HealthCare compared tegoprazan (P-CAB) with pantoprazole (PPI), 88-96 percent of subjects treated with tegoprazan maintained the PH level above 6 on both the first day of administration and the seventh day.
In contrast, 49.7 percent of those treated with pantoprazole maintained over PH 6 on the first day, and 58.3 percent, on the seventh day. As K-Cab was superior in maintaining PH level above 5, it is expected to eradicate Helicobacter pylori as well, the company said.