Ildong Pharmaceutical has jumped into developing P-CAB (potassium-competitive acid blockers)-based treatment for gastroesophageal reflux disease (GERD), drawing the industry’s attention to the market once again.
Last Thursday, the Ministry of Food and Drug Safety approved the domestic phase 1 trial of ID120040002.
Ildong plans to evaluate the safety, tolerance, pharmacokinetics, and pharmacological characteristics of ID120040002 by administering it once or several times in healthy male adults. The Seoul National University Hospital will carry out the clinical trial.
The domestic P-CAB market is divided between HK inno.N’s K-CAB (tegoprazan) and Daewoong Pharmaceutical’s Fexuclue (fexuprazan). According to market watchers, both drugs have won the status of homegrown new drugs and are expanding their respective treatment indications through additional clinical trials.
The two companies are also showing similar marketing strategies, expanding their export destinations by stressing that the treatments are excellent in inhibiting night acid secretion compared to existing proton pump inhibitors (PPIs) and work fast. Besides, HK inno.N is diversifying formulations by introducing oral decay films and others.
Jeil Pharmaceutical is also stepping up efforts to P-CAB medicines. Onconic Therapeutics, Jeil’s affiliate focusing on new drugs, is developing a candidate substance, JP-1336, and won the ministry’s approval for a domestic phase 3 clinical trial in June. Its earlier plan to conduct a phase 3 clinical trial in Europe will likely proceed after the completion of the domestic trials.
Against this backdrop of fierce competition to develop or commercialize P-CAB drugs, Ildong has thrown its gauntlet.
Industry analysts predict more Korean drugmakers will jump into the fray.
“Given that P-CAB drugs, like the existing PPI medicines, treat an ulcer in digestive organs by inhibiting gastric acid secretion, makers can try to expand their indication to duodenal and other ulcers, and also seek their prescriptions with other drugs for gastrointestinal protection,” an industry executive said." “As long as there is room for prescription, latecomers can jump into the market anytime."
In the past, GERD patients were mostly in Europe. Still, an increasing number of Chinese people complain of the same symptoms now, which explains the zeal among Korean pharma firms to develop P-CAB medicines, the executive added.