Anavex Life Sciences Corp. will initiate a Phase 2a clinical trial for the treatment of Alzheimer’s disease with their compounds – ANAVEX 2-73 and ANAVEX PLUS – after receiving regulatory approval by the Ethics Committee in Australia.
ANAVEX 2-73, an orally available drug candidate, is under investigation to treat Alzheimer’s disease. In previous preclinical studies, ANAVEX 2-73 was shown to prevent, halt, and/or reverse Alzheimer’s disease progression by targeting sigma-1 and muscarinic receptors and reducing oxidative stress in neurons, which is believed to lead to their damage and ultimately death.
The Phase 2a trial will enroll 32 mild to moderate Alzheimer’s disease patients and aims to evaluate bioavailability, dose finding and response, cognitive efficacy, and whether ANAVEX 2-73 added to donepezil — known as “ANAVEX PLUS” — is a potentially effective add-on therapy. Donepezil, an acetylcholinesterase inhibitor, is the current standard therapeutic for Alzheimer’s disease patients. Specifically, data from a previous Phase 1 human clinical trial showed ANAVEX 2-73 was efficient in preventing amnesia events and had neuroprotective properties when administered to Alzheimer’s disease patients. ANAVEX PLUS was also shown to have a high synergistic effect being able to revert memory loss in Alzheimer’s disease patients, with approximately 80% higher efficiency comparing to other drugs.
Alzheimer’s disease currently affects more than 25 million people, and it is estimated to reach 100 million by 2050.
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex commented, “The approval is a major milestone for Anavex. We believe it signifies the acceptance of the state-of-the-art methodologies we have incorporated into our clinical trial, which include both adaptive trial features and population pharmacokinetics. The Company’s innovative trial design allows us to capture and maximize key information about ANAVEX 2-73 in the most efficient way. This is an exciting time for our Company given the properties of ANAVEX 2-73 and the vast unmet medical needs for Alzheimer’s disease.”