Daewoong Pharmaceutical said that it has confirmed that fexuprazan, its gastroesophageal reflux disease (GERD) treatment, showed a 99 percent cure rate in the treatment of endoscopic mucosal defects up to eight weeks in a local phase-3 trial.
The company presented the trial results during the 2020 Digestive Disease Week in the U.S. As the in-person event was canceled due to Covid-19 outbreak, the conference presented poster results of highly promising drug candidates including fexuprazan, online.
Fexuprazan is a P-CAB (Potassium-Competitive Acid Blocker) formulation with a mechanism to reversibly block the proton pump that secretes gastric acid from the stomach wall.
P-CAB is regarded as the next-generation medicine to replace proton pump inhibitors (PPI), often used for GERD.
The company has completed the phase-3 clinical study for the drug on patients with erosive GERD in Korea and is conducting additional clinical trials to obtain indications related to various acid secretions.
The study presented at the conference was conducted in 25 hospitals in Korea for patients with erosive GERD.
The results of the trial showed good tolerability and safety with little discomfort or side effects. The drug also suppressed gastric acid secretion, which can simultaneously improve the endoscopic treatment rate and symptoms, the company said.
From the beginning of the administration, heartburn symptoms improved immediately, regardless of day or night, and cough symptoms, which is one of the atypical symptoms GERD, also improved, Daewoong said.
Notably, when administering the drug to patients with severe symptoms, the company confirmed that the drug improved heartburn symptoms in up to three times as many patients when compared with the esomeprazole-treated group.
The drug candidate’s strong efficacy helped the company sign an agreement to export the drug to Mexico in January.
“The company expects that the results of this study will lead to active partnerships for the rapid commercialization of fexuprazan in global markets such as China and the U.S.,” Daewoong CEO Jeon Seng-ho said.