Onconic Therapeutics Announces Positive Phase 3 Results for JAQBO at Digestive Diseases Week 2024

2024-05-29

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临床结果临床3期上市批准

SEOUL, South Korea and WASHINGTON, May 29, 2024 /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 Washington D.C. from May 18-21, 2024.

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 highlight the efficacy and safety of JAQBO for patients with erosive esophagitis," said John Kim, Ph.D., CEO of Onconic Therapeutics. "The recent approval by the MFDS of Korea is a significant milestone for Onconic Therapeutics. We are hopeful that JAQBO can improve patient care globally by providing rapid and sustained relief from symptoms, and we are committed to pursuing its development for broader international markets."

In March 2023, JAQBO was licensed to Livzon Pharmaceutical Group, the leading pharmaceutical company in China, for development and commercialization in the Greater China market.

About Zastaprazan

Zastaprazan, developed by Onconic Therapeutics, was approved for the treatment of erosive esophagitis under the brand name JAQBO by the Ministry of Food and Drug Safety (MFDS) of Korea in April 2024.

About Onconic Therapeutics

Onconic Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs. The company is dedicated to improving patient outcomes and providing innovative healthcare solutions for cancer and gastrointestinal disorders.

SOURCE Onconic Therapeutics

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