Onconic Therapeutics has initiated a clinical trial to expand the indications for its gastroesophageal reflux disease (GERD) treatment, Jaqbo.
The company announced on Wednesday that it submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase 3 clinical trial aimed at securing approval for maintenance therapy following treatment of erosive gastroesophageal reflux disease (active ingredient: Zastaprazan), a domestically developed P-CAB class drug.
Erosive gastroesophageal reflux disease refers to a condition where stomach acid refluxes into the esophagus, leading to actual damage to the esophageal lining. Unlike cases that present only with symptoms, this condition shows signs of erosion or inflammation during endoscopy and is known to be a chronic disease with frequent relapses even after treatment.
This clinical trial aims to secure indications for maintenance therapy to suppress symptom recurrence after treatment. GERD is characterized by the recurrence of symptoms in a significant number of patients after treatment discontinuation, underscoring the need for long-term management.
The Phase 3 trial focuses on a low-dose maintenance therapy based on half of the existing treatment dose (10 mg, compared to 20 mg). The plan is to evaluate the efficacy and safety in a long-term treatment setting of up to six months. If the trial is successful, Jaqbo will broaden its application to encompass not only acute treatment but also relapse management.
Since receiving approval as a treatment for erosive gastroesophageal reflux disease in 2024, Jaqbo added an indication for gastric ulcers the following year. The company is currently conducting Phase 3 trials for preventing ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs) and for the non-erosive reflux disease (NERD) indication. In January, they also launched an orally disintegrating tablet (ODT) to enhance patient convenience.
Global expansion is also in progress. Onconic’s partner in China, Livzon Pharmaceutical Group Inc., applied for approval for the erosive gastroesophageal reflux disease indication from the National Medical Products Administration of China last August. Onconic Therapeutics Inc. has received milestone payments under a technology transfer agreement. The gastroesophageal reflux disease treatment market in China is estimated to be worth approximately 6 trillion KRW (around 3.97 billion USD).
A representative from Onconic Therapeutics stated that this maintenance therapy trial is significant for expanding the prescription base of Jaqbo in terms of duration and dosage. Based on the experience with domestic approval and commercialization, it plans to enhance the global scalability while accelerating the development of the subsequent oncology pipeline.