Daewoong Pharmaceutical Unveils Phase 3 Clinical Data of Fexuprazan, A Novel Potassium-competitive Acid Blocker

SEOUL,South Korea,May 11,2020 -- Daewoong Pharmaceutical (Daewoong) unveiled for the first time the phase 3 clinical data of Fexuprazan,a novel gastroesophageal reflux disease agent at Digestive Disease Week (DDW) 2020. The abstract of Fexuprazan has been rated in the top 10% posters of all American Gastroenterological Association (AGA) abstracts selected for poster presentation and selected as a Poster of Distinction for presentation during Digestive Disease Week.

Fexuprazan Phase 3 results

Fexuprazan is a novel potassium-competitive acid blocker (P-CAB) developed by Daewoong,which reversibly blocks the proton pump that secretes gastric acids located in the cannalicular membrane. It is a next-generation of proton pump inhibitors (PPI),which are widely used for gastroesophageal reflux disease (GERD). A phase 3 clinical trial of Fexuprazan was conducted in Korea in patients with erosive esophagitis,and additional clinical trials are ongoing for other acid-related diseases.

The phase 3 clinical trial in patients with erosive esophagitis was conducted in 25 hospitals in Korea. Fexuprazan showed 99% of mucosal healing rate at week 8 and was well tolerated in the patients. Fexuprazan also showed improved symptom relief. Particularly,in the patients with moderate to severe symptoms,Fexuprazan exhibited significantly faster and better heartburn relief compared to Esomeprazole and this heartburn relief was shown to be maintained during nighttime. Furthermore,atypical symptom such as cough was also improved with the treatment of Fexuprazan.

Coordinating investigator Oh Young Lee M.D.,Ph.D. at the Division of Gastroenterology of Hanyang University Hospital said,"Through this promising results in the erosive esophagitis patients,Fexuprazan has proven to become a best alternative for the treatment of GERD and to fulfill the medical unmet needs of the current therapies by providing with the fast and effective relief from heartburn as well as endoscopic healing."

Sengho Jeon,CEO of Daewoong,said,"We are committed to developing a novel and improved therapeutic options,and are very excited that Fexuprazan will be a valuable addition to the current treatment for acid-related diseases. We expect accelerated development of Fexuprazan through partnerships and will soon have a unique opportunity to commercialize Fexuprazan in the global markets such as US and China.

In January,Daewoong signed an agreement with Moksha8,a leading pharmaceutical company in Latin America. As Daewoong began the successful entry into the global market,Fexuprazan is expected to position as a next global blockbuster drug in the anti-acid secretion agent market valued $37 billion.

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