Press release
Anavex Life Sciences Receives Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73 (blarcamesine) into Multinational Clinical Trial for Alzheimer’s Disease
NEW YORK, June 04, 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, June 04, 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) diseases, today announced that it has received a No Objection Letter from Health Canada as well as Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to expand the Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX®2-73-AD-004) of ANAVEX®2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and UK, respectively.\n The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled. “We are excited to receive the regulatory approvals for this Phase 2b/3 study for patients seeking treatment for Alzheimer’s disease,” commented Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This expansion into North America and Europe should accelerate the completion of the enrollment of the ongoing ANAVEX®2-73-AD-004 Alzheimer’s disease Phase 2b/3 trial with ANAVEX®2-73 (blarcamesine).” About ANAVEX®2-73 (blarcamesine) ANAVEX®2-73 (blarcamesine) activates the Sigma-1 receptor (S1R) protein, which serves as a molecular chaperone and functional modulator involved in restoring homeostasis. S1R activation has demonstrated ability to reduce key pathophysiological signs of Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and increased inflammation. In the Phase 2a 57-week Alzheimer’s disease (AD) ANAVEX®2-73-002 (ClinicalTrials.gov NCT02244541) study, ANAVEX®2-73 (blarcamesine) has shown dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL). Its open-label extension study ANAVEX®2-73-003 (ClinicalTrials.gov NCT02756858) for an additional 208 weeks included full genomic analysis of patients with Alzheimer’s disease treated with ANAVEX®2-73 (blarcamesine). A 48-week Phase 2b/3 study ANAVEX®...