Anavex Life Sciences has received approval from the Australian Human Research Ethics Committee to begin a Phase llb/lll clinical trial to evaluate the safety and efficacy of ANAVEX 2-73 for the treatment of early Alzheimer’s disease.
Around 450 patients are expected to be enrolled in the double-blind, randomised, placebo-controlled, 48-week trial.
The patients will be randomised in a 1:1:1 ratio to receive two different ANAVEX 2-73 doses or placebo within the next month.
Primary and secondary objectives of the trial will examine safety, as well as cognitive and functional efficacy, measured via Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), Alzheimer's Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).
In addition, the trial will include genomic precision medicine biomarkers identified in a Phase lla study of ANAVEX 2-73 for Alzheimer’s disease, which previously showed dose-dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).
The global trial is expected to include sites in North America.
Anavex Life Sciences president and CEO Christopher Missling said: “We are extremely pleased to gain approval to initiate the ANAVEX 2-73 Phase 2b/3 study for the treatment of early Alzheimer’s disease, an area of very high unmet need for the growing number of patients around the world.”
ANAVEX 2-73 is designed to activate the Sigma-1 receptor (S1R) protein that works as a molecular chaperone and functional modulator involved in restoring homeostasis.
S1R activation has showed its ability to minimise key pathophysiological signs of Alzheimer’s disease, including beta amyloid, hyperphosphorylated tau, and increased inflammation.