Zastaprazan citrate

韩国首尔和华盛顿特区 2024年5月29日 /美通社/ -- 致力于开发肿瘤和胃肠道疾病创新疗法的临床阶段生物制药公司Onconic Therapeutics在2024年5月18日至21日在华盛顿特区举行的2024美国消化疾病周(DDW)上公布了JAQBO（zastaprazan柠檬酸盐）的3期ZERO-1研究结果。 韩国Eunpyeong St. Mary's Hospital教授兼胃肠病学家、ZERO-1研究的主要作者Jung-hwan Oh博士在口头报告会上介绍了3期试验结果。这项随机、双盲、主动对照研究比较了zastaprazan与埃索美拉唑在糜烂性食管炎患者中的疗效和安全性。参与者每天接受20毫克zastaprazan或40毫克埃索美拉唑，持续长达八周。在300名招募患者中，研究表明，zastaprazan组在第8周的累积愈合率为97.9%，而埃索美拉唑组为94.9%。到第 4 周，zastaprazan的愈合率为 95.1%，而埃索美拉唑的愈合率为 87.7%，差异有统计学意义。这些结果证实zastaprazan不劣于埃索美拉唑。此外，zastaprazan在一小时内起效迅速，并且24小时内胃内pH值保持在4以上的时间达到85%，突出了其有效缓解夜间胃酸反流症状的潜力及其持久的功效。 Onconic Therapeutics首席执行官John Kim博士表示："我们对ZERO-1研究的积极结果感到鼓舞，该研究突出了JAQBO对糜烂性食管炎患者的疗效和安全性。"最近获得韩国MFDS的批准是Onconic Therapeutics的一个重要里程碑。我们希望JAQBO能够通过快速和持续地缓解症状来改善全球患者护理，并致力于在更广阔的国际市场中继续发展。" 2023年3月，中国领先的制药公司丽珠医药集团获得授权，在大中华市场进行JAQBO的开发和商业化。 关于 Zastaprazan 2024年4月，由Onconic Therapeutics开发的Zastaprazan被韩国食品药品安全部(MFDS)批准用于治疗糜烂性食管炎，商品名为JAQBO。 关于 Onconic Therapeutics Onconic Therapeutics 是一家临床阶段的生物制药公司，专注于开发新型疗法，以解决未满足的医疗需求。该公司致力于提升患者的治疗效果，为癌症和胃肠道疾病提供创新的医疗解决方案。

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