Anavex Life Sciences has successfully completed its phase I single ascending dose (SAD) clinical trial of ANAVEX 2-73, the company's lead drug candidate for the treatment of Alzheimer's Disease. ANAVEX 2-73 is the first of a new class of oral drugs being studied to potentially treat AD through disease modification rather than focusing only on symptomatic improvement.
In this phase I SAD study, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous systems (CNS) conditions, including AD.
The ANAVEX 2-73 phase I trial was conducted as a randomized, placebo controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer's Disease studies, and the Technical University of Dresden.