Anavex Life Sciences has enrolled the first patient in a Phase llb/lll trial to examine the safety and efficacy of ANAVEX2-73 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.
As part of the trial, the patients will be randomised in a 1:1:1 ratio to receive two different doses of ANAVEX2-73 or placebo.
The trial will be conducted across the globe, including sites in North America.
Its primary and secondary endpoints will evaluate the safety and cognitive and functional efficacy of ANAVEX2-73, measured using ADAS-Cog, ADCS-ADL and CDR-SB.
The trial’s principal investigator Stephen Macfarlane said: “This highly anticipated trial has generated great interest in Australia and overseas, and we now look forward to a phase of rapid recruitment of those who have registered their intent to participate.”
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In addition, the trial’s design features genomic precision medicine biomarkers identified in a previous Phase lla study of ANAVEX2-73.
The Phase lla trial showed dose-dependent improvement in exploratory endpoints of cognition and function of the study drug.
Anavex president and CEO Christopher Missling said: “This is an important step toward achieving clinical data in regard to the treatment of early Alzheimer’s disease, which continues to represent an area of very high unmet need for the growing number of patients globally.
“Incorporating genomic precision medicine biomarkers identified in the ANAVEX2-73 Phase lla study is an incredibly important aspect of this study and we look forward to the insights gained through this data.”
ANAVEX2-73 is designed to activate the Sigma-1 receptor (S1R) protein, which acts as a molecular chaperone and functional modulator required to restore homeostasis.
Previous activation of S1R has established an ability to reduce major pathophysiological signs of Alzheimer’s disease, such as beta amyloid, hyperphosphorylated tau, and increased inflammation.