NEW YORK - 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, Parkinson's disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that it has met its enrollment target for the ANAVEX2-73 (blarcamesine) Phase 2 study in Parkinson's Disease Dementia (PDD).

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 Spain (Europe) along with 3 sites in Australia.

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 Cognitive Drug Research (CDR) Computerized Assessment System, MDS-UPDRS (Motor Scores) and incidence of Sleep Disorders Symptom Checklist (SDS-CL-25). ANAVEX2-73 (blarcamesine) previously demonstrated in a Phase 2a Alzheimer's disease study dose dependent improvement in exploratory endpoints of cognition (ERP/EEG, Cogstate, Mini-Mental State Examination - MMSE) within 5 weeks.

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 Parkinson's Foundation estimates that 1 million Americans have Parkinson's disease. It is estimated that up to 80 percent of those with Parkinson's disease eventually experience Parkinson's disease dementia. The brain changes caused by Parkinson's disease begin in a region that plays a key role in movement. As Parkinson's brain changes gradually spread, they often begin to affect mental functions, including memory and the ability to pay attention, make sound judgments and plan the steps needed to complete a task.[3]

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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