Daewoong Pharmaceutical said that it has completed the phase 3 clinical trial for Fexuprazan, a candidate for gastroesophageal reflux disease (GERD) treatment.
|Daewoong headquarters in Samsung-dong, southern Seoul.|
The drug is a potassium-competitive acid blocker (P-CAB) that has a mechanism for reversibly blocking gastric acid-proton pumps in the stomach wall. The company has been conducting the phase 3 clinical trial at 25 hospitals in 260 patients with erosive GERD since Oct. 2018.
In phase 3 clinical trials, the drug showed a high rate of 99 percent for treating endoscopic mucosal defects up to eight weeks and demonstrated good tolerability with less discomfort or side effects. The heartburn symptom also immediately improved regardless of the day and night from the beginning of the administration and eased coughing symptoms, one of GERD's atypical symptoms.
"Such benefits have allowed us to confirm that the drug is effective in gastric acid secretion inhibitors, which can improve the endoscopic treatment rate and symptom improvement," the company said.
Daewoong Pharmaceutical CEO Jeon Seng-ho also said, "We plan to focus our capabilities on additional research and development by securing follow-up indications and differentiation data to develop Fexuprazan as a best-in-class GERD treatment."
The company is actively seeking overseas partnerships to achieve results not only in Korea but also in global markets, such as China and the United States, Jeon added.