Daewoong Pharmaceutical Presents 'Pexuclu' Clinical Trial at World's Largest Gastroenterology Conference

Daewoong Pharmaceutical announced clinical results on the efficacy and safety of the new drug for gastroesophageal reflux disease (GERD), 'Pexuclu,' at the world's largest gastroenterology conference.

DDW 2023 Daewoong Pharmaceutical booth view. [Photo by Daewoong Pharmaceutical]

Daewoong Pharmaceutical revealed on the 10th that it set up a Pexuclu booth at the 'Digestive Disease Week 2023 (DDW 2023)' held in Chicago, USA, for four days starting from the 6th, and presented two clinical data sets proving the efficacy and safety of Pexuclu in patients with erosive gastroesophageal reflux disease (GERD) at the overseas conference.

DDW is the largest gastroenterology conference where more than 10,000 doctors, researchers, and industry digestive experts from around the world gather to share the latest research and clinical experiences. Currently participating in this conference, Daewoong Pharmaceutical is operating the Pexuclu booth and conducting academic exchanges with gastroenterology specialists from various countries based on new clinical trial results.

The two poster presentations held on the 7th (local time) consisted of ▲a researcher-initiated clinical study conducted in Korea comparing the mucosal defect healing rates when Pexuclu was administered before and after meals ▲an analysis of the results of a Phase 3 clinical trial conducted in China to evaluate the efficacy and safety of Pexuclu for the treatment indication of GERD.

The clinical trial led by Professor Sung Dong-kyung of Konkuk University’s Department of Gastroenterology evaluated the efficacy and safety of once-daily Pexuclu administration after meals compared to before meals in patients with erosive GERD. The proportion of patients whose mucosal defects were completely healed at 2 and 4 weeks after Pexuclu administration was confirmed, and there was no significant difference in treatment effect between the pre-meal and post-meal administration groups. The company explained that Pexuclu shows the same efficacy regardless of food intake, which would help improve patient medication convenience. Additionally, during the 2- and 4-week treatment rate confirmation process, the rapid onset and therapeutic effect of Pexuclu were confirmed.

Safety was also confirmed. In the evaluation of adverse drug reactions, there was no statistically significant difference in the incidence of adverse drug reactions between the pre-meal and post-meal administration groups, and no serious adverse drug reactions occurred. Accordingly, since no clinically significant adverse reactions requiring special attention were observed in either group, the company emphasized that Pexuclu was confirmed to be a safely administrable drug.

Professor Sung, the principal investigator of this researcher-initiated clinical trial, said, "Pexuclu is the first potassium-competitive acid blocker (P-CAB) to demonstrate the same therapeutic effect regardless of pre- or post-meal administration, securing an excellent advantage in dosing convenience." He added, "By confirming the treatment rates at 2 and 4 weeks respectively in this study, we demonstrated Pexuclu’s outstanding effect of suppressing gastric acid secretion faster and more strongly than PPIs, and we expect it to show excellent effects in various acid-related diseases in the future."

The Phase 3 non-inferiority randomized controlled trial conducted in China for the treatment of erosive GERD compared the mucosal defect healing rates confirmed by upper gastrointestinal endoscopy up to 8 weeks, which was the efficacy evaluation indicator. The study results showed a healing rate of 97.3% in the Pexuclu group and 97.9% in the esomeprazole (40 mg) group, proving that the treatment effect was not inferior to the active comparator esomeprazole. In addition, the safety evaluation results, including adverse drug reactions, were similar to those of the active comparator esomeprazole.

Professor Xiao Yinglian of Sun Yat-sen University, who presented the results of the Chinese Phase 3 clinical trial, stated, "Compared to proton pump inhibitors (PPIs), P-CABs have the advantage of showing drug efficacy within one day and demonstrate the same efficacy regardless of pre- or post-meal administration. Gradually, P-CABs will replace PPIs, and Pexuclu will play a leading role in this trend."

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "We are planning and conducting various domestic and international clinical trials continuously to add follow-up indications for Pexuclu." He added, "We plan to focus our capabilities on strengthening Pexuclu’s product competitiveness by securing differentiated data that can prove the drug’s efficacy and developing various formulations."

Pexuclue 40mg. [Image provided by Daewoong Pharmaceutical]

This content was produced with the assistance of AI translation services.