Daewoong Pharmaceutical's New GERD Drug 'Pexuclu Tablets' Pre-Released at International Academic Conference

2022 Korean Society of Upper Gastrointestinal and Helicobacter Academic Conference Scene.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical showcased its new drug for gastroesophageal reflux disease, 'Pexuclu Tablets,' at an international academic conference.

Daewoong Pharmaceutical announced on the 25th that it presented the Phase 3 clinical trial results of Pexuclu Tablets at the Korean Society of Upper Gastrointestinal and Helicobacter Conference held at the Swiss Grand Hotel in Seoul on the 18th and 19th. The conference was held simultaneously online and offline, with a total of 570 participants from 23 countries.

According to the Phase 3 clinical trial results of Pexuclu presented by Professor Kim Kwang-ha of the Department of Gastroenterology at Busan National University Hospital at this conference, the rate of patients whose mucosal defects were completely healed after 8 weeks of Pexuclu administration was 99.1%, demonstrating a high treatment rate for erosive esophagitis. Among proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs), Pexuclu has the longest half-life (about 9 hours), allowing for once-daily single tablet dosing and excellent improvement in nocturnal acid breakthrough (NAB).

Additionally, unlike most PPI formulations that must be taken before meals, Pexuclu can be taken regardless of meals, improving patient medication convenience. It also has a low risk of drug interactions with medications metabolized via the CYP2C19 pathway, such as Clopidogrel. Clinical trials conducted on Koreans, Japanese, and Caucasians showed similar acid suppression effects, demonstrating consistent efficacy regardless of race.

Furthermore, Pexuclu showed superior and faster improvement compared to Esomeprazole in typical symptoms of gastroesophageal reflux disease such as 'heartburn' and atypical symptoms like 'chronic cough.' Especially in moderate to severe patients, the proportion of patients without heartburn on the third day of administration was 22.4%, three times higher than that of Esomeprazole.

Pexuclu is a new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical, belonging to the P-CAB class of drugs that reversibly block proton pumps responsible for gastric acid secretion in the stomach lining. Daewoong Pharmaceutical is currently developing various additional indications for Pexuclu, including Phase 3 trials for maintenance therapy after erosive gastroesophageal reflux disease treatment and prevention of ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs).

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