Is a Three-Way Battle for 'P-CAB' Starting? Onconic's 'Jastaprajan' Phase 3 Clinical Trial Revealed for the First Time

Development Name 'JP-1366' New Drug for Gastroesophageal Reflux Disease
First Revealed at the European Gastroenterology Congress

P-CAB Rapidly Replacing PPI
Domestic Marketing Authorization Application Also Completed

Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, has revealed for the first time the Phase 3 clinical trial results of 'Jastaprazan (JP-1366)', a new drug under development for gastroesophageal reflux disease (GERD).

Professor Oh Jeong-hwan of the Department of Gastroenterology at Eunpyeong St. Mary's Hospital is presenting the Phase 3 clinical data of Zastaflazan for the first time at the United European Gastroenterology Week (UEGW) held in Copenhagen, Denmark.
[Photo by Onconic Therapeutics]

Onconic Therapeutics announced on the 17th that it presented the Phase 3 clinical data of Jastaprazan for the first time at the 2023 United European Gastroenterology Week (UEGW 2023), held from the 14th to the 17th in Copenhagen, Denmark. UEGW is the largest European conference composed of more than 50,000 healthcare professionals and scientists worldwide.

Jastaprazan is a next-generation potassium-competitive acid blocker (P-CAB) drug that is rapidly replacing proton pump inhibitors (PPIs), which have been primarily used in the market for gastroesophageal reflux disease and peptic ulcer treatments. P-CAB formulations have recently gained attention for their various advantages over PPIs in the treatment of GERD. PPIs require administration 30 minutes before meals and have inconveniences such as promoting acid secretion at night. Side effects like osteoporosis and stroke have also been controversial. However, P-CAB drugs can be taken regardless of meal times and are evaluated to improve nighttime heartburn.

This announcement was based on the analysis of Phase 3 clinical trial results comparing the efficacy and safety of Jastaprazan and esomeprazole in patients with erosive gastroesophageal reflux disease, conducted by Professor Oh Jung-hwan of the Department of Gastroenterology at Eunpyeong St. Mary's Hospital. The clinical trial involved 300 patients in a multicenter, randomized, double-blind, active-controlled study design, where Jastaprazan 20 mg or esomeprazole 40 mg was randomly assigned once daily for up to 8 weeks. As a result, Jastaprazan showed a high treatment rate of 97.9%, and notably, after 4 weeks of administration, it demonstrated a 7.44% higher treatment rate than the comparator group, ultimately proving that Jastaprazan is not inferior to the control drug esomeprazole in terms of efficacy and safety.

Jastaprazan plans to accelerate commercialization by expanding its indications not only for erosive GERD but also for gastric ulcers. In June, it submitted a New Drug Application (NDA) to the Korean Ministry of Food and Drug Safety, and earlier in March, it signed a technology export contract worth $127.5 million (approximately 172 billion KRW) with China's Livzon Pharmaceutical Group for the development and commercialization of Jastaprazan.

Kim John, CEO of Onconic Therapeutics, said, “It is meaningful to be able to announce the potential success of Jastaprazan as a new drug to medical professionals worldwide at the largest European gastroenterology conference. We will accelerate efforts to commercialize it as a domestic new drug and focus our capabilities on expanding its indications.”

This content was produced with the assistance of AI translation services.