The Company expects to announce topline results from this study by mid-2020.
ANAVEX2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.[1]
The study enrolled over 120 patients at 20 sites across
This multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of two different once daily oral ANAVEX2-73 (blarcamesine) doses or placebo.
The ANAVEX2-73 (blarcamesine) Phase 2 PDD study design incorporates genomic precision medicine biomarkers. Primary and secondary endpoints will assess cognition and Parkinsonian motor symptoms and sleep function during the 14-week study.[2] The efficacy assessments include the
To offer eligible participants of the Phase 2 PDD study access to ANAVEX2-73 (blarcamesine), participants completing the trial may enroll in a voluntary 48-week open-label extension study.
'A significant unmet need exists currently for Parkinson's disease patients since up to 80% of Parkinson's patients develop dementia, and we are excited to have fully enrolled this study for ANAVEX2-73 (blarcamesine), meeting the high-end of our targeted range,' said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. 'Given ANAVEX2-73's (blarcamesine) oral route of administration we believe it has the potential to deliver broad clinical utility.'
About Parkinson's Disease Dementia (PDD)
Parkinson's disease is a fairly common neurological disorder in older adults, estimated to affect nearly 2 percent of those older than age 65. The
About ANAVEX2-73 (blarcamesine)
ANAVEX2-73 (blarcamesine) activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. In a Phase 2a Alzheimer's disease (AD) study, ANAVEX2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and activities of daily living (ADCS-ADL). Full genomic analysis of ANAVEX2-73 (blarcamesine) Phase 2a AD patients was performed. The ANAVEX2-73 (blarcamesine) Phase 2 PDD study design includes genomic biomarkers identified in the ANAVEX2-73 (blarcamesine) Phase 2a AD study. Studies of ANAVEX2-73 (blarcamesine) in a disease modifying model of Parkinson's disease indicates that ANAVEX2-73 (blarcamesine) is well tolerated, induces significant motor recovery (p
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