-=Anavex (AVXL) : positive data in Parkinson's disease dementia trial

 

Anavex announces "positive" results from proof of concept controlled Phase 2 clinical trial evaluating ANAVEX2-73 (blarcamesine) in Parkinson's disease dementia

The study found that ANAVEX2-73 (blarcamesine) was safe and well tolerated in oral doses up to 50 mg once daily. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker of response to ANAVEX2-73 (blarcamesine). The ANAVEX2-73-PDD-001 study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study and randomized 132 patients with PDD equally to target doses of 30mg, 50mg ANAVEX2-73 (blarcamesine) or placebo, respectively.

In addition to safety and cognitive efficacy, sleep function was assessed during the study at week 8 and week 14. ANAVEX2-73-PDD-001 study results will be submitted for presentation at a medical conference and for publication in a peer-reviewed medical journal. Anavex is planning a pivotal trial of ANAVEX2-73 (blarcamesine) in Parkinson's disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance.