JEIL PHARMACEUTICAL(271980) subsidiary Onconic Therapeutics(476060) said on the 3rd that it received approval from the Ministery of Food and Drug Safety for a phase 3 clinical trial plan (IND) to seek approval for Helicobacter pylori eradication therapy for Korea's 37th domestically developed new drug, a potassium-competitive acid blocker (P-CAB), "Ja Q Bo (ingredient name: zasdaprozan)."
This trial aims to expand Ja Q Bo's treatment range from the existing gastroesophageal reflux disease and gastric ulcers to Helicobacter pylori eradication therapy. If the trial succeeds, the drug could be used not only to treat acid-related diseases but also to eliminate the causative bacteria.
The clinical trial will enroll 414 patients who test positive for Helicobacter pylori at 24 institutions in Korea. It will compare the efficacy and safety of a triple therapy combining Ja Q Bo, amoxicillin, and clarithromycin with the existing lansoprazole-based triple therapy. Patients will receive the medications twice daily for two weeks, and eradication will be assessed at least four weeks after the end of dosing.
Helicobacter pylori is a causative bacterium that leads to gastritis, peptic ulcers, and gastric cancer. As antibiotic resistance has recently spread, failure cases in eradication therapy have increased, raising the need for new treatments. In particular, P-CABs provide faster and stronger acid suppression than conventional proton pump inhibitors (PPIs), maintaining the effect and creating a gastric environment more suitable for antibiotic action.
A clinical trial for Ja Q Bo's eradication therapy is also underway in China. Local partner Livzon Pharmaceutical has been conducting a phase 3 trial there since May. The triple therapy will be evaluated in Korea, and a quadruple therapy tailored to the local standard of care will be evaluated in China.
Ja Q Bo is currently used to treat erosive gastroesophageal reflux disease and gastric ulcers, and trials are also underway to broaden its indications to non-erosive gastroesophageal reflux disease, maintenance therapy after treatment, and the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers.
An Onconic Therapeutics official said, "This phase 3 approval is an important step for Ja Q Bo to broaden its treatment area beyond existing acid-related diseases into the Helicobacter pylori eradication therapy market, which has a large patient base," adding, "As we are simultaneously pursuing phase 3 eradication therapy in Korea and China, we will continue to expand Ja Q Bo's indications and strengthen its competitiveness in the global eradication therapy market."