(Health Korea News / Lee Soon-ho) Jeil Pharmaceutical is expected to soon complete the clinical trial for the first follow-up indication of its new potassium-competitive acid blocker (P-CAB) drug, ‘JAQBO (ingredient name: Zastaprazan)’, aimed at treating gastric ulcers.
According to the Ministry of Food and Drug Safety on the 30th, Onconic Therapeutics, a new drug development subsidiary of Jeil Pharmaceutical, recently completed the final subject observation of the phase 3 clinical trial of ‘Jacubojeong’ targeting gastric ulcer patients.
The clinical trial is currently in the patient recruitment stage. The final subject recruitment was completed in May, and observation of the last subject who completed the schedule specified in the clinical trial plan was also recently completed.
Considering that clinical trials are typically completed and move to the data analysis phase once the final subject observations are completed, Onconic Therapeutics is expected to change the status of this clinical trial to closed soon.
The phase 3 clinical trial of ‘Jakyubojeong’ for gastric ulcers was approved by the Ministry of Food and Drug Safety in May 2022 and began in earnest by registering the first subject in September of the same year. The number of subjects targeted by the company is 328. The final number of subjects actually recruited has not been disclosed yet, but considering that the test was conducted for a considerable period of two years, it is estimated that the number of subjects recruited is close to the original plan.
‘Jakyubojeong’ is a next-generation P-CAB series new drug that is expected to replace the existing PPI (proton pump inhibitor) drugs in the market for peptic ulcer drugs such as gastroesophageal reflux disease. It is the third P-CAB drug that a domestic pharmaceutical company has successfully developed, following HK inno.N’s ‘K-CAB (ingredient name: Tegoprazan)’ and Daewoong Pharmaceutical’s ‘Fexuclue (ingredient name: Fexuprazan)’.
Onconic Therapeutics is also conducting a new phase 3 clinical trial to secure an indication for preventing nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers in addition to gastric ulcers. The clinical trial plan was approved in April and the recruitment of subjects is scheduled to begin next month.
The reason the company is focusing on expanding the indications is because there is a limit to taking away the market share of the major competing drugs, PPI preparations, with only the indication for treating gastroesophageal reflux disease. Currently, the indications for esomeprazole preparations, a representative PPI ingredient, are 6, and the indications for lansoprazole preparations are 10.
For this reason, three pharmaceutical companies, including HK inno.N and Daewoong Pharmaceutical, which own P-CAB preparations, including Onconic Therapeutics, are engaging in a fierce competition to expand indications.
HK inno.N’s ‘K-Cap’ has the five most indications, including ▲treatment of erosive gastroesophageal reflux disease ▲treatment of non-erosive gastroesophageal reflux disease ▲treatment of gastric ulcers ▲combination therapy with antibiotics for eradication of Helicobacter pylori ▲maintenance therapy after treatment of erosive gastroesophageal reflux disease (limited to 25 mg dose).
In addition, a phase 3 clinical trial is underway for the purpose of preventing NSAID-induced peptic ulcers, and a phase 1 clinical trial has been completed to confirm whether it suppresses gastrointestinal bleeding side effects when administered together with oral anticoagulants (NOACs).
Daewoong Pharmaceutical’s ‘Pexuclu tablet’ has two indications: ▲Treatment of erosive gastroesophageal reflux disease and ▲Improvement of gastric mucosal lesions in acute and chronic gastritis (limited to 10 mg dose).
As it was launched three years later than ‘K-Cap’, the number of indications is relatively small, but to overcome this, follow-up clinical trials are being expedited.
Daewoong Pharmaceutical is currently conducting phase 3 clinical trials for two indications related to ‘Pexuclu’: ▲Prevention of NSAID-induced peptic ulcers and ▲Maintenance therapy for patients with cured erosive gastroesophageal reflux disease. It plans to continue research on additional indications, such as combination therapy with antibiotics for eradication of Helicobacter pylori.
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