, /PRNewswire/ -- Onconic Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for oncology and gastrointestinal disorders, announced today the results of its Phase 3 ZERO-1 study of JAQBO (zastaprazan citrate) at Digestive Disease Week (DDW) 2024, held in from . Dr. Jung-hwan Oh, MD, PhD, a professor and gastroenterologist at Eunpyeong St.
Mary's Hospital in Korea, and the lead author of the ZERO-1 study, presented the phase 3 trial results during an oral presentation session. This randomized, double-blind, active-controlled study compared the efficacy and safety of zastaprazan to esomeprazole in patients with erosive esophagitis. Participants received either 20 mg of zastaprazan or 40 mg of esomeprazole daily for up to eight weeks.
Among the 300 enrolled patients, the study demonstrated a cumulative healing rate of 97.9% in the zastaprazan group at week 8, compared to 94.9% in the esomeprazole group.
By week 4, the healing rate was 95.1% for zastaprazan compared to 87.7% for esomeprazole, a statistically significant difference.
These results confirmed that zastaprazan is non-inferior to esomeprazole. Additionally, zastaprazan showed a rapid onset of action within one hour and maintained a gastric pH above four for 85% of the 24-hour period, highlighting its potential to effectively alleviate nighttime acid reflux symptoms with its long-lasting efficacy. "We are encouraged by the positive results of the ZERO-1 study, which hi.