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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.

Anavex Life Sciences announced that the company has received approval from the Spanish Agency for Medicinal Products and Medical Devices, or AEMPS, to initiate its Phase 2, double-blind, placebo-controlled 14-week trial of the safety and efficacy of ANAVEX 2-73 for the treatment of Parkinson's disease dementia, or PDD. The Phase 2 study is scheduled to initiate enrollment of approximately 120 patients, randomized 1:1:1 to two different ANAVEX 2-73 doses or placebo, within the next few months, in up to 24 clinical study sites.