China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD).
Study Design and Outcomes
The Phase III study was a double-blind, double-simulation, randomized, placebo/positive parallel controlled trial that aimed to assess the efficacy and safety of octohydroaminoacridine succinate in AD patients. The study successfully reached its primary endpoint, demonstrating a clinically significant improvement in the Alzheimer’s Disease Assessment Scale-Cognitive section (ADAS-Cog) for the treatment group. Safety results indicated that the incidence of adverse events and adverse reactions for octohydroaminoacridine succinate was lower than that of the control drug treatment group, with significant statistical differences observed compared to the placebo group.
In Vitro and Early Clinical Findings
In vitro experiments have shown that octohydroaminoacridine succinate exhibits several times higher inhibitory ability against two types of cholinesterase, ethyl and butyl, compared to conventional first-line drugs, suggesting better clinical therapeutic effects. Early clinical trials have already verified the clinical efficacy and safety of the drug, positioning it as a promising treatment for Alzheimer’s disease.-Fineline Info & Tech