Press release
Anavex Life Sciences Announces Positive Results from Proof of Concept controlled Phase 2 Clinical Trial Evaluating ANAVEX®2-73 (blarcamesine) in Parkinson’s Disease Dementia
Clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"Clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis\n Company to host conference call today at 8:30 AM ET NEW YORK, Oct. 15, 2020 (GLOBE NEWSWIRE) -- 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 disorders including Alzheimer’s disease (AD), Parkinson’s disease (PD), Rett syndrome and other central nervous system (CNS) diseases, today announced results from the proof of concept Phase 2 controlled trial evaluating the safety, tolerability, and efficacy of ANAVEX®2-73 (blarcamesine) in patients with Parkinson’s disease dementia (PDD). The study found that ANAVEX®2-73 (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 ANAVEX®2-73 (blarcamesine). The ANAVEX®2-73-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 ANAVEX®2-73 (blarcamesine) or placebo, respectively. In addition to safety and cognitive efficacy, sleep function was assessed during the study at week 8 and week 14. ANAVEX®2-73-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 ANAVEX®2-73 (blarcamesine) in Parkinson’s disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance. Dr. Jaime Kulisevsky Bojarski, MD, PhD, Full Professor of Neurology & Vice-Dean Faculty of Medicine Autonomous University of Barcelona and Director of the Movement Disorders Unit, Department of Neurology, Sant Pau Hospital and Principal Investigator in the trial, commented, \"As the first double-blind trial of ANAVEX®2-73 (blarcamesine) in PDD, this proof-of-concept study provides extremely encouraging data. PDD can be debilitat...