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Anavex Life Sciences Announces Achievement of Enrollment Target for the ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s Disease Dementia (PDD) Clinical Trial
NEW YORK, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"NEW YORK, Jan. 27, 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, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that it has met its enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in Parkinson’s Disease Dementia (PDD). The Company expects to announce topline results from this study by mid-2020.\n ANAVEX®2-73 (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 ANAVEX®2-73 (blarcamesine) doses or placebo. The ANAVEX®2-73 (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). ANAVEX®2-73 (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 ANAVEX®2-73 (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 ANAVEX®2-73 (blarcamesine), meeting the high-end of our targeted range,\" said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. \"Given ANAVEX®2-73’s (blarcamesine) oral route of administration we believe it has the p...