Onconic Therapeutics Receives Approval for Phase 3 Clinical Trial of New Drug for Gastroesophageal Reflux Disease Treatment
[Asia Economy Reporter Chunhee Lee] Onconic Therapeutics, a new drug development subsidiary of Jeil Pharmaceutical, is entering Phase 3 clinical trials for its new drug candidate 'JP-1366' for the treatment of reflux esophagitis.
Onconic Therapeutics announced on the 16th that it recently received approval from the Ministry of Food and Drug Safety for the Phase 3 clinical trial plan of 'JP-1366.'
This clinical trial will be conducted to compare and evaluate the efficacy and safety of administering 20 mg of 'JP-1366' or 40 mg of esomeprazole in patients with reflux (erosive) esophagitis. It will be a multicenter clinical trial with randomized allocation, double-blinding, parallel design, active control, and non-inferiority evaluation.
Until now, proton pump inhibitor (PPI)-based drug therapy has been primarily prescribed for the treatment of reflux esophagitis. However, recently, potassium-competitive acid blockers (P-CAB), which offer advantages such as rapid onset of action and dosing time independent of meals, have emerged, raising expectations that they may become the standard therapy.
JP-1366 is a P-CAB-based treatment for reflux esophagitis that has advantages over existing PPI drugs in both therapeutic effect and duration. It was selected as an advanced medical technology development project by the Ministry of Health and Welfare in 2017 and received over 2 billion KRW in research funding, demonstrating its potential as a promising anticancer drug.
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An Onconic Therapeutics official stated, “With the emergence of new drugs in the P-CAB class, the existing treatment paradigm is shifting, raising great expectations for market potential. We will strive to complete the clinical trials of JP-1366 promptly and proceed with the approval process to meet patients' expectations.”
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