China-based Shandong Xinhua Pharmaceutical Co., Ltd (SHE: 000756) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study of its innovative Alzheimer’s disease (AD) drug, OAB-14. The study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and food effects of OAB-14 in healthy subjects. A separate Phase I study will also evaluate the drug’s safety and tolerability, pharmacokinetics, and pharmacodynamics in patients with mild-to-moderate AD.
Development and Preclinical Data
Xinhua Pharma entered into an agreement with Shenyang Pharmaceutical University to develop OAB-14 in early 2018. In the completed pharmacodynamic study, OAB-14 demonstrated significant reductions in amyloid beta protein deposition in the brain, a hallmark of Alzheimer’s disease. This finding underscores the drug’s potential as a novel therapeutic option for patients with AD.
Market Landscape and Future Outlook
Currently, there are no small-molecule amyloid beta clearing drugs under development, making OAB-14 a potentially groundbreaking treatment. While Biogen/Eisai’s monoclonal antibodies aducanumab and lecanemab have been approved in the US, OAB-14 represents a unique approach in targeting amyloid beta through a small-molecule drug. The initiation of Phase I clinical trials marks a significant step forward in the development of OAB-14, positioning Xinhua Pharma to address significant unmet needs in Alzheimer’s disease treatment.-Fineline Info & Tech
