The company will recruit around 450 patients in the double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial.
The patients will be randomized 1:1:1 to two different Anavex 2-73 doses or placebo within the next month. Anavex will add North American sites, as part of the planned international study.
Anavex 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors.
The drug candidate also showed its potential to halt and/or reverse the course of Alzheimer’s disease in preclinical studies.
Anavex Life Sciences president and CEO Dr Christopher U 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.”
The trial’s design is comprised of genomic precision medicine biomarkers identified in the Anavex 2-73 phase 2a study.
Primary and secondary endpoints will evaluate safety and both cognitive and functional efficacy, measure via ADAS-Cog, ADCS-ADL and CDR-SB.
Earlier, the Anavex 2-73 phase 2a Alzheimer’s disease study showed dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).
Anavex 2-73 is said to activate the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator engaged in restoring homeostasis.
According to the company, the S1R activation has showed ability to reduce crucial pathophysiological signs of Alzheimer’s disease, including beta amyloid, hyperphosphorylated tau and increased inflammation.
Anavex Life Sciences is a clinical-stage biopharmaceutical firm engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases, including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer.