US-based clinical-stage biopharmaceutical company Anavex Life Sciences has reported positive results from its ANAVEX 2-73 (Blarcamesine) Phase II study for treating patients with Parkinson’s disease dementia.
In the trial, the company tested two doses of ANAVEX 2-73 at 30mg and 50mg against placebo on randomised 132 patients with Parkinson’s disease dementia.
According to the company, ANAVEX 2-73 treatment led to mRNA expression increase of SIGMAR1, the drug’s target, and it correlated significantly with clinical efficacy as measured by primary cognitive efficacy endpoints.
Data indicates that activation of SIGMAR1 helps in restoring complete housekeeping function within the body.
ANAVEX 2-73 study data also demonstrated statistically significant improvements compared to placebo.
The difference of Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score at the end of 14 weeks between the ANAVEX 2-73 arm and placebo arm was -14.51 points.
The data represents a relative improvement of 18.9 % over the 14-week period.
ANAVEX 2-73 treatment slowed the progression of motor and non-motor symptoms in moderately advanced patients with Parkinson’s disease as well as had a positive effect on REM sleep behaviour disorder.
Anavex president and CEO Christopher U. Missling said: “This is now the second independent placebo-controlled clinical ANAVEX 2-73 Phase II study to confirm the predictive biomarker of response established with SIGMAR1 mRNA expression.
“Both ANAVEX 2-73-PDD-001 Parkinson’s disease dementia study and the recently reported ANAVEX 2-73-RS-001 U.S. Rett syndrome study are persuasively consistent with the proposed mechanism for ANAVEX 2-73.
“We believe that the easily accessible predictive biomarker combined with the observed efficacy is a consistent explanation of the efficacy in this second largest CNS indication with unmet medical need. This data further strengthens the foundation of ANAVEX 2-73 as a cross-platform (central nervous system) CNS drug.”
Anavex will submit the data from this study later this year at a scientific medical meeting.