On 28 June, Anavex Life Sciences Corp - a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative diseases – reported new data from its Phase II clinical trial for the treatment of people with Parkinson’s disease dementia (PDD).
The ANAVEX2-73-PDD-001 study was a randomised, international, double-blind, multicentre and placebo-controlled proof of concept Phase II clinical trial that enrolled 132 people with PDD who received blarcamesine, also named ANAVEX2-73, (30 or 50 mg) or placebo. Results showed that the drug was generally safe, well tolerated and had significant improvements in symptom scores on primary and secondary endpoints for people with PDD. After 14 weeks of treatment, the higher dose of blarcamesine demonstrated statistically significant clinical improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis and the Movement Disorder Society’s Unified Parkinson Disease Rating Scale (MDS-UPDRS), compared to placebo. These tests evaluated cognition and both motor and non-motor symptoms associated with PD. These improvements were linked to an increase in the expression of the SIGMAR1 mRNA biomarker, which is involved in the transport of lipids and proteins within the cell and plays a role in the development of neurodegenerative diseases. Blarcamesine is designed to activate SIGMAR1.
The company plans to present these data this year at a scientific conference and submit them to the US Food and Drug Administration (FDA) to seek regulatory guidance.
