Shandong Xinhua Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Shenzhen (SHE: 000756), has declared the successful completion of a Phase I clinical trial for its OAB-14 drug candidate in a dry suspension formulation. Following the positive outcome, the company is now gearing up to initiate a Phase IIa study later this year. This multi-center, randomized, double-blinded, placebo-controlled trial will evaluate the safety, tolerability, efficacy, and pharmacokinetics of OAB-14 in patients with Alzheimer’s disease (AD).
The Category 1 drug, co-developed with Shenyang Pharmaceutical University, is targeted for the treatment of mild to moderate Alzheimer’s disease. OAB-14’s mechanism of action is primarily focused on the clearance of amyloid beta from the brain, complemented by a multi-target approach that includes central anti-inflammatory effects, antioxidant properties, and the inhibition of neuronal apoptosis. This drug candidate has the potential to significantly diminish beta amyloid deposition in the brain, reduce the hyperphosphorylation of Tau protein, and safeguard the integrity and functionality of the cerebral cortex, hippocampal neurons, and synapses. The Phase I clinical trials have demonstrated that OAB-14 dry suspension is well-tolerated and safe in healthy adult subjects.- Flcube.com
