Daewoong Pharmaceutical said it obtained regulatory approval to conduct a phase-3 clinical trial next-generation antiulcer drug, “DWP14012.” The drugmaker aims to win sales license for the treatment by 2020.
The new antiulcer therapy draws attention as an agent to replace proton-pump inhibitor (PPI) medicines, which reduce stomach acid production. The phase-3 trial will evaluate the efficacy and safety of the investigational drug in 260 local patients with erosive gastroesophageal reflux disease.
According to Daewoong, DWO14012, a potassium-competitive acid blocker (P-CAB), showed a rapid and strong inhibition of gastric acid secretion, compared to conventional PPI agents, in the phase-1 trial. The company said it checked the agent’s hepatotoxicity biomarker as well, hoping to develop a safe antiulcer treatment.
The experimental drug acts fast and inhibits the production of gastric acid for 24 fours, having a superior efficacy than that of rival treatments with the same mechanism, Daewoong said.
Patients will be able to take medicine regardless of meals, and the drug will have low chemical interactions with other medications thanks to the drug’s various metabolic pathways, the company added.
In February, Daewoong’s investigational antiulcer drug was selected as part of the “pan-governmental full-cycle new drug development project.” In April, the pharmaceutical company presented the drug’s all data from the candidate substance discovery to the phase-1 study at the Asian Postgraduate Course on Neurogastroenterology and Motility (APNM 2018), an academic symposium of the Korean Society of Gastroenterology.
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