Press release
Anavex Life Sciences Announces Exceeding of Enrollment Target for the Precision Medicine ANAVEX®2-73 (blarcamesine) Phase 2b/3 Clinical Trial in Patients with Alzheimer’s Disease
NEW YORK, June 08, 2021 (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, June 08, 2021 (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) diseases, today announced that it has exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2b/3 study in Alzheimer’s disease. The Company expects to announce topline results from this study by mid-2022. The study includes a prespecified precision medicine biomarker, SIGMAR1 gene expression, which demonstrated correlation with direct measures of clinical benefit, cognition and activities of daily living and function in a previous Phase 2a Alzheimer’s disease study.1 The double-blind, placebo-controlled 450-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer's disease exceeded enrollment beyond 450 patients at 52 sites across North America, Europe and Australia using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.2 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. ANAVEX®2-73 is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.3 PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.4 “A significant unmet need exists currently for Alzheimer’s disease patients worldwide given the lack of available adequate therapeutic interventions, and we are excited to have exceeded enrollment of this study for ANAVEX®2-73,\" said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. \"Given ANAVEX®2-73’s convenient oral route of administration we believe it has the potential to deliver broad clinical utility.\" Anavex Life Sciences’ product portfolio includes small drug molecule lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syn...