Jeil Pharmaceutical "Onconic Therapeutics Applies for Phase 3 Clinical Trial Approval of 'P-CAB GERD New Drug'"

[Asia Economy Reporter Hyunseok Yoo] Jeil Pharmaceutical announced on the 1st that its subsidiary Onconic has submitted an Investigational New Drug (IND) application for the P-CAB reflux esophagitis new drug candidate (JP-1366) to the Ministry of Food and Drug Safety.

Reflux esophagitis is classified into erosive and non-erosive types, where erosion refers to a damaged state of the gastric mucosa. The erosive esophagitis, in which damage to the esophageal mucosa is observed and which will be conducted by Onconic Therapeutics, is a disease that can lead to complications such as ulcers, strictures, and adenocarcinoma in severe cases. Proton pump inhibitors (PPIs) have mainly been used for treatment.

Onconic plans to conduct Phase 3 clinical trials both domestically and in Europe. To this end, it recently obtained QP (Qualified Person) certification, a prerequisite for European clinical trials, confirming that the production and distribution of clinical trial drugs comply with European standards. Accordingly, in the fourth quarter, Onconic intends to conduct domestic Phase 3 clinical trials and submit a Clinical Trial Application (CTA) for the European Phase 3 trial to regulatory authorities in European countries.

JP-1366 is a calcium-competitive acid blocker (P-CAB) drug characterized by rapid onset and long-lasting efficacy. P-CAB class therapeutics are currently the focus of global clinical development by Japanese pharmaceutical company Takeda and domestic companies Innoen, Daewoong, and Onconic to secure the global market. Takeda’s vonoprazan is known to be leading the global development competition.

Takeda is conducting a Phase 3 clinical trial of the P-CAB drug vonoprazan in the United States through its spin-off company, Phathom Pharmaceuticals, gaining an advantage in the global market development race.

By advancing the European Phase 3 clinical trial of the P-CAB new drug JP-1366 in the fourth quarter of this year, Onconic Therapeutics plans to enhance its global development competitiveness by becoming the second company to enter global Phase 3 clinical trials following Takeda.