GOOD NEWS | Phase 1 clinical trial of the innovative drug OAB-14 of Xinhua Pharmaceutical for the treatment of Alzheimer’s disease successfully completes
On August 22, Xinhua Pharmaceutical convened a summary meeting for the phase 1 clinical study of its innovative drug OAB-14 indicated to treat Alzheimer’s disease (AD) and organized an expert review of the phase 2 clinical study protocol of this product in Beijing. This marks the successful completion of the phase 1 clinical study and paves the way to enter the phase 2 clinical study.
The meeting was jointly organized by Shandong Xinhua Pharmaceutical Co., Ltd. and the Beijing Stoke Association, and was moderated by Dong Lingyun, the general manager of Beijing YEEDOZENCOM Tech. Ltd.
He Tongqing, Party Secretary and Chairman of Xinhua Pharmaceutical, delivered a welcoming speech, extending warm welcome to the attendees and expressing sincere gratitude for their efforts during the clinical study of OAB-14 and their continuous support for Xinhua Pharmaceutical. He also briefly reported on Xinhua Pharmaceutical’s development history and achievements in technological innovation.
Tang Yi, Deputy Director of Xuanwu Hospital of Capital Medical University, delivered a summary during the meeting, offering full recognition to the phase 1 clinical study of OAB-14 and providing forward-looking and instructive suggestions on the phase 2 clinical study protocol. He expressed that the choice of Xinhua Pharmaceutical to develop innovative drugs indicated to treat AD reflects its mission of “Protecting Health and Benefiting Society” and its responsibilities as a state-owned enterprise, and he wished for the expectations in the subsequent studies of OAB-14.
OAB-14 is a Class 1 innovative chemical drug jointly developed by Xinhua Pharmaceutical and Shenyang Pharmaceutical University, intended for the treatment of mild to moderate AD. With proprietary intellectual property, this product features a novel mechanism of action as an anti-AD candidate drug. It primarily involves not only the clearance of Aβ in the brain but also mechanisms of multiple targets, including central anti-inflammation, antioxidant effects, and inhibition of neuronal apoptosis. OAB-14 significantly reduces β-amyloid deposition in the brain and decreases excessive phosphorylation of Tau protein, while protecting the structure and function of cortical and hippocampal neurons and synapses.
Xinhua Pharmaceutical received the clinical trial approval letter in January 2023 and initiated the phase 1 clinical trial in March 2023. The phase 1 clinical study was conducted to assess preliminary clinical pharmacology and safety profile and to evaluate the tolerability and pharmacokinetic characteristics of the product in humans. Based on the available results, the OAB-14 dry-mixed suspension demonstrated good safety and tolerability in healthy adult subjects. The results from the phase 1 clinical study support the phase 2 clinical study.
In the future, Xinhua Pharmaceutical will continue increasing investment in research and development, move forward the clinical trial and marketing approval of OAB-14, aiming to provide a new treatment option for AD patients as soon as possible. Yeedozencom has supported and will support Xinhua Pharmaceutical’s needs related to the OAB-14 project, ensuring smooth and accelerated progress through close cooperation.
