Daewoong Pharmaceutical said that it has presented its phase 1 multiracial clinical trial for DWP14012, a gastroesophageal reflux disease (GERD) treatment candidate, during the United European Gastroenterology held in Barcelona, Spain.
|Daewoong headquarters in Samsung-dong, southern Seoul.|
DWP 14012 is a gastric acid pump antagonist with a reversible inhibitory mechanism. The drug is classified as a proton pump inhibitors drug widely used in treating GERD.
The company is conducting phase 3 clinical trials in Korea for treating patients with erosive gastroesophageal reflux disease, as well as those to obtain indications for various acid secretions. The phase 3 trial, conducted at the Seoul National University Hospital, investigated the pharmacokinetic and pharmacodynamic characteristics of DWP14102 in healthy Korean, Caucasian, and Japanese adults.
Placebo-controlled, single and repeated trials confirmed the inhibition effect of blood concentration and gastric acid secretion in the stomach. The company confirmed that there was no difference among varied ethnic groups in the pharmacokinetic and pharmacodynamic properties.
Daewoong held a pre-investigational new drug application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in July, and confirmed that the research data is valid during the IND application process.
"We are trying hard to complete the phase 3 clinical trial of DWP14012 in Korea and develop it as a best-in-class gastroesophageal reflux disease drug to enter the global market," Daewoong Pharmaceutical CEO Jeon Seng-ho said. "As our company is moving forward with the FDA's IND submission this year, we expect active partnering for the rapid commercialization of the DWP14012 in the global market."