Korean-developed potassium-competitive acid blockers (P-CABs), which have competed in the gastroesophageal reflux disease (GERD) market, are expanding their indications into the eradication of Helicobacter pylori.
Daewoong Pharmaceutical (069620.KS) confirmed a 92.0% eradication rate among patients who completed treatment in a concomitant therapy study in which Fexuclue and three antibiotics used for H. pylori eradication were each administered for 10 days, according to the pharmaceutical industry on the 17th. The eradication rate reached 90.3% based on all enrolled patients. Notably, 80.0% of patients with confirmed antibiotic resistance-related mutations also achieved eradication.
Fexuclue previously went through a Phase 3 trial and won additional approval from the Ministry of Food and Drug Safety on April 30 this year for the indication of "combination therapy with antibiotics for the eradication of Helicobacter pylori." The latest study is significant in that it adds clinical evidence that can be applied in actual prescribing following the approval. By confirming an eradication effect of more than 90% in concomitant therapy using three antibiotics, following the earlier approval trial, the company has secured grounds to broaden treatment options.
Behind the growing presence of P-CABs in H. pylori eradication therapy is antibiotic resistance. Administering existing treatments together with antibiotics had been the main approach, but as resistant strains have increased, a decline in the eradication rate of existing therapies has been raised as a problem.
The first to take the lead in eradication therapy was HK inno.N (195940.KQ). In 2023, K-CAB became the first among domestic P-CAB class treatments to receive national health insurance coverage for combination therapy with antibiotics for H. pylori eradication. HK inno.N plans to expand into research on personalized treatment that first checks for antibiotic resistance and then selects a therapy suited to each patient.
Onconic Therapeutics (476060.KQ), a latecomer, is also picking up pace. Early this month, it won approval from the Ministry of Food and Drug Safety for a Phase 3 trial of Jaqbo in H. pylori eradication therapy. It is also conducting a Phase 3 trial in China through its partner Livzon Pharmaceutical.
An official in the pharmaceutical industry said, "Competition among P-CABs is shifting beyond acid suppression to securing indications and clinical evidence," adding, "Proving high eradication rates amid antibiotic resistance will be the core of competitiveness."
