Daewoong Pharmaceutical presented the multiracial phase 1 clinical test results of ‘DWP14012,’ a drug for gastroesophageal reflux disease, at the United European Gastroenterology (UEG Week).

Daewoong Pharmaceutical presented the multiracial phase 1 clinical test results of ‘DWP14012,’ a drug for gastroesophageal reflux disease, at the United European Gastroenterology (UEG Week) - The phase 3 clinical study in Korea targeting best-in-class for gastroesophageal reflux disease. - Registered INN as ‘Fexuprazan,’ a substance of ‘DWP14012,’ last September. Daewoong Pharmaceutical (CEO Sengho Jeon) presented the posters of the clinical data of ‘DWP14012’ (INN: Fexuprazan), the new drug for gastroesophageal reflux disease, at the 2019 UEG Week (United European Gastroenterology) held in Barcelona, Spain last 23rd (local time). ‘DWP 14012 (Fexuprazan),’ the drug for gastroesophageal reflux disease (GERD), is an innovative potassium-competitive acid blocker (P-CAB). P-CAB is a novel anti-acid secretion agent which has a mechanism of action distinct from PPI (proton pump inhibitor). Different from PPIs, it reversibly binds proton pump and immediately exerts its effects. The phase 3 clinical study of DWP14102 is currently progressing smoothly on patients with erosive GERD and additional clinical studies are being conducted for application to various gastric symptoms. The multiracial phase 1 clinical study took place at Seoul National University Hospital on healthy Korean, Caucasian, and Japanese adults to identify the pharmacokinetic and pharmacodynamic responses according to the dosage of DWP14102 (Fexuprazan).  We tested blood concentration and inhibition of gastric secretion in the stomach through placebo control, single and repeated administration and confirmed that there is no racial difference in the pharmacokinetic and pharmacodynamic responses. Daewoong Pharmaceutical had a Pre-IND meeting with the U.S. FDA last July and confirmed that the research data can be used for the U.S. FDA IND (application for clinical studies) process.  This is expected to lay the foundation for Daewoong Pharmaceutical’s global business. “We are putting out best efforts to complete the phase 3 clinical study of Fexuprazan, the new-generation drug for gastroesophageal reflux disease, on patients with erosive gastroesophageal reflux disease during this year and develop the best-in-class drug for gastroesophageal reflux disease targeting the global market,” said CEO Sengho Jeon of Daewoong Pharmaceutical.  “As we are preparing to submit the U.S. FDA IND, we expect to accelerate the partnering process for fast commercialization of Fexuprazan in the global market.” The substance of ‘DWP14012’ is ‘Fexuprazan’ and its INN (International Nonproprietary Name) has been registered with WHO last September.  INN is the official name given by WHO to identify the pharmaceutical substances.  It is assigned according to the 'WHO INN Naming' guidelines. #   #   # [Image] Daewoong Pharmaceutical presented the posters of the results of phase 1 results of ‘DWP14012’, the new drug for gastroesophageal reflux disease, at the 2019 UEG Week (United European Gastroenterology).

The release as fetched from its publisher. daewoong.co.kr ↗