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

Seoul, South Korea And WASHINGTON, May 29, 2024 /CNW/ — Onconic Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for oncology and gastrointestinal disorders, today announced results from its Phase 3 ZERO-1 study of JAQBO ( zastaprazan citrate) during Digestive Disease Week (DDW). 2024, organized at Washington, D.C. Since May 18-21, 2024.

Dr. Jung-hwan Oh, MD, PhD, professor and gastroenterologist at Eunpyeong St. Mary’s Hospital in Korea, and senior author of the ZERO-1 study, presented the results of the Phase 3 trial at 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 patients included, the study demonstrated a cumulative cure rate of 97.9% in the zastaprazan group at week 8, compared to 94.9% in the esomeprazole group. At week 4, the cure rate was 95.1% for zastaprazan compared to 87.7% for esomeprazole, a statistically significant difference. These results confirmed that zastaprazan is not inferior to esomeprazole. Additionally, zastaprazan showed rapid onset of action within one hour and maintained gastric pH above four for 85% of the 24-hour period, highlighting its potential to effectively relieve nocturnal acid reflux symptoms through to its long-term effectiveness.

“We are encouraged by the positive results from 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 of Korea’s MFDS is an important milestone for Onconic Therapeutics. We hope that JAQBO can improve patient care globally by providing rapid and lasting symptom relief, and we are committed to its continued expansion into broader international markets.

In March 2023JAQBO was licensed by Livzon Pharmaceutical Group, the country’s leading pharmaceutical company. Chinafor the development and marketing in the Greater China walk.

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 therapeutic products to address unmet medical needs. The company is dedicated to improving patient outcomes and providing innovative healthcare solutions for cancer and gastrointestinal disorders.

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