Wednesday, 27 October 2021

Daewoong reveales Ph 3 data of novel gastroesophageal reflux disease agent

11 May 2020 | News

Clinical Data of Fexuprazan proved its efficacy with outstanding inhibition of gastric acid secretion and safety in Phase 3 clinical trial

Photo credit: Pexels

Photo credit: Pexels

Daewoong Pharmaceutical (Daewoong) from South Korea 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 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.

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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