Anavex Life Sciences has announced screening of the first healthy volunteers for the Phase One clinical study of Anavex 2-73, its lead compound for the treatment of Alzheimer's disease.
Anavex 2-73 is the first of a new class of wholly-owned, oral, disease-modifying compounds, which act through sigma-1 receptor agonism as well as muscarinic cholinergic effects and up-regulation of Bcl-2.
The compound also modulates endoplasmic reticulum stress and triggers a series of intracellular effects thought to modify ion channel signalling at the mitochondrial level.
In preclinical studies, Anavex 2-73 and active metabolite Anavex 19-144 alleviated neurotoxicity and cognition deficits associated with Alzheimer's disease in animals.
Toxicity studies in mice, rats and dogs showed a favourable safety profile.
The Phase One trial, in at least 16 healthy volunteers, is a randomised, placebo-controlled, dose-escalating study designed to assess the safety, tolerability and pharmacokinetics of oral Anavex 2-73 and will help determine the maximally tolerated dose in humans.
The study is being carried out in collaboration with ABX-CRO, which has conducted various Alzheimer's disease studies, and the University of Dresden in Germany.