Onconic Therapeutics Receives IND Approval for Phase 3 Clinical Trial of 'JP-1366' in Gastric Ulcer

[Asia Economy Reporter Chunhee Lee] Onconic Therapeutics announced on the 2nd that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 3 trial plan (IND) of the new drug candidate for gastric ulcer treatment, ‘JP-1366’.

This clinical trial will administer either 20 mg of 'JP-1366' or 30 mg of lansoprazole to patients with gastric ulcers to comparatively evaluate efficacy and safety. The trial will be conducted at over 30 institutions, including Korea University Guro Hospital, using randomized allocation, double-blind, parallel design, active control, and non-inferiority methods.

JP-1366 is a new drug candidate based on a ‘potassium-competitive acid blocker (P-CAB)’. Recently, the gastrointestinal disease market, including gastroesophageal reflux disease and gastric ulcers, which mainly used drugs with the ‘proton pump inhibitor (PPI)’ mechanism, is rapidly being reorganized around P-CAB formulations. PPIs must be taken 30 minutes before meals and have the inconvenience of promoting acid secretion at night. Side effects such as osteoporosis and stroke have also been controversial. However, P-CABs can be taken regardless of meal times and have improved nighttime heartburn.

Previously, Onconic Therapeutics also received approval last December for the phase 3 clinical trial plan of JP-1366 as a new drug candidate for reflux esophagitis treatment.

An Onconic Therapeutics official stated, “If the phase 3 clinical trial of JP-1366 is successfully completed, market entry is expected to be much easier,” and added, “We will also expedite the approval process and expect it to become an innovative treatment that addresses the unmet needs of gastric ulcer patients.”

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