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Anavex announced that it has enrolled the first patient in its Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of Anavex2-73 for the treatment of early Alzheimer's disease. The Phase 2b/3 study will enroll approximately 450 patients, randomized 1:1:1 to two different Anavex2-73 doses or placebo. As part of the planned international study, North American sites will be added. The Anavex2-73 Phase 2b/3 study design incorporates genomic precision medicine biomarkers identified in the Anavex2-73 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. Anavex2-73 Phase 2a Alzheimer's disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition, or MMSE and function, or ADCS-ADL.

Anavex Life Sciences reported results of the entire genome DNA and RNA evaluation of study participants in a 57-week Phase 2a Alzheimer's disease study investigating ANAVEX 2-73, a selective sigma-1 receptor agonist, resulting in the analysis of 33,311 genes and 860 pathways. Additionally, direct target occupancy of ANAVEX 2-73 at the sigma-1 receptor using quantitative Positron emission tomography scanning was presented. Several genetic variants that impacted response to ANAVEX 2-73 were identified in the study analysis including the Sigma-1 receptor, the target for ANAVEX 2-73, and the Catechol-O-methyltransferase gene, produced by nerve cells and involved in memory function. Results showed that study participants with SIGMAR1 or COMT variants were less likely to benefit from treatment with ANAVEX 2-73. In the study population, when participants with these variants were excluded, the remaining study participants showed improved scores on gold-standard tests of cognition and activities of daily living. Including participants with milder disease and excluding those with a SIGMAR1 variant resulted in an average improvement of +1.7 MMSE and +3.9 ADCS-ADL at week 57 compared to baseline. The additional exclusion of participants with the COMT variant resulted in a score improvement of +2.0 MMSE and +4.9 ADCS-ADL at week 57 compared to baseline.