Livzon Pharmaceutical Group, Inc.

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

Onconic Therapeutics announced on Wednesday that Jaqbo (zastaprazan citrate) demonstrated efficacy and safety in a Phase III study of patients with erosive esophagitis. The results on the next-generation potassium competitive blocker (P-CAB) were presented at Digestive Disease Week (DDW)."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," said CEO John Kim. Jaqbo was approved for the treatment of erosive esophagitis by the Ministry of Food and Drug Safety (MFDS) of Korea in April.The ZERO-1 trial compared the efficacy and safety of Jaqbo to AstraZeneca's Nexium (esomeprazole) in 300 patients with erosive esophagitis. Participants received either Jaqbo or Nexium daily for up to eight weeks.Non-inferior to NexiumAt week eight, the cumulative healing rate was 97.9% in the Jaqbo group and 94.9% in the Nexium group. By week four, the respective healing rates were 95.1% and 87.7%, representing a statistically significant difference. The results confirm that Jaqbo is non-inferior to Nexium.Additionally, Jaqbo 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," the company said.In 2023, Jaqbo was licensed to China's Livzon Pharmaceutical Group for development and commercialisation in the Greater China market.

SEOUL, South Korea, April 25, 2024 /PRNewswire/ -- Onconic Therapeutics, a leading biotechnology company in Korea, today announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in adults. JAQBO is a next-generation potassium competitive blocker (P-CAB) expected to become the new standard treatment in the market for gastric acid related diseases. JAQBO directly binds to proton pumps in a competitive manner to reduce gastric acid secretion. This novel mechanism allows quick onset of action regardless of the acidity level in the stomach, offering immediate symptom relief. In addition, longer duration of acid suppression with no food effect could provide a new paradigm in GERD treatment. The MFDS approval of JAQBO is based on comprehensive results including the Phase III clinical trial across 28 sites in Korea. The study demonstrated JAQBO's effectiveness on erosive esophagitis, with a healing rate of 97.9% after 8 weeks of treatment. These results were presented at the United European Gastroenterology Week in October 2023. Onconic Therapeutics aims to launch JAQBO this year after listing for National Healthcare Insurance Reimbursement in Korea. Domestic sales of JAQBO will be handled by Jeil Pharmaceutical, Onconic Therapeutics's parent company. In March 2023, JAQBO was licensed out to Livzon Pharmaceutical Group, the leading seller of PPIs in China for development and commercialization, in a deal value of $127.5 million for Greater China. Onconic Therapeutics is committed to enhancing gastrointestinal treatment and improving patient outcomes by expanding additional indications. About Onconic Therapeutics Onconic Therapeutics is a Korean leader in developing novel drugs. With a focus on innovative research and clinical excellence, Onconic Therapeutics is dedicated to improving patient outcomes and providing quality healthcare solutions for cancer and gastrointestinal disorders. Forward-Looking Statement This press release contains forward-looking statements that are based on our current expectations, forecasts, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected. Forward-looking statements include statements about our future financial performance, business strategy, plans and objectives. Factors that could cause such differences include but are not limited to economic conditions, market demand, competitive pressures, and regulatory changes. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. SOURCE Onconic Therapeutics