- ANAVEX®2-73 Being Studied as Potential First Precision Medicine Biomarker-guided, Targeted Therapeutic in Alzheimer’s Disease
- Primary and Secondary Endpoints measuring Safety, and Cognitive and Functional Efficacy (ADAS-Cog, ADCS-ADL and CDR-SB)
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Company has received approval by the Australian Human Research Ethics Committee to initiate its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study is scheduled to initiate enrollment of approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo within the next month. As part of the planned international study, North American sites will be added.
“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,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the ANAVEX®2-73 Phase 2a study. Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).