Press release
Anavex Life Sciences Announces Exceeding of Enrollment Target for the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett Syndrome Clinical Trial
NEW YORK, June 16, 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 16, 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 surpassed by 50% the company’s original enrollment target for the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 study in Rett syndrome. The Company expects to announce topline results from this study in 2H 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 multi-center, double-blind clinical trial at 8 sites across U.S. is measuring safety, tolerability, and efficacy of daily oral ANAVEX®2-73 (blarcamesine) doses or placebo. After completing the trial, eligible participants are able to join a voluntary open-label extension study of ANAVEX®2-73 (blarcamesine). Anavex previously reported interim data of the PART A intensive PK sub-cohort in the first 6 patients of the U.S. Phase 2 Rett syndrome study in which ANAVEX®2-73 (blarcamesine) demonstrated significant improvements of the two global efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score and the Clinical Global Impression – Improvement (CGI-I). ANAVEX®2-73 (blarcamesine) also significantly improved the RSBQ Hand Behaviours and the RSBQ Breathing Abnormalities. In addition, efficacy signals on both caregiver- and clinician-based measures of severity correlated with levels of glutamate, a key biomarker of disease pathogenesis. This study is one of three ongoing clinical studies in Anavex’s Rett Syndrome Program: U.S. RTT (ANAVEX®2-73-RS-001)2, AVATAR (ANAVEX®2-73-RS-002)3 and EXCELLENCE (ANAVEX®2-73-RS-003)4. ANAVEX®2-73 (blarcamesine) had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome. “Since there is currently no approved agent to treat this devastating disease, there is a significant unmet medical need for patients with Rett syndrome,” said Christopher U. Missling, PhD, President and...