NEW YORK – August 6, 2024
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended June 30, 2024.
“We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the Phase 2b/3 clinical trial of blarcamesine (ANAVEX®2-73), which were presented at the Alzheimer’s Association International Conference (AAIC), showing that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events. We are also pleased to report that the clinical team continues to beat the planned timelines in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71 in schizophrenia patients,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Additionally, we remain dedicated to developing medicines for individuals suffering from brain disorders within neurodegenerative and neurodevelopmental disorders, which could further expand our differentiated precision medicine platform to deliver scalable treatment options coupled with convenient oral dosing.”
Key Pipeline Updates:
Alzheimer’s disease:
Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application (MAA) to the European Medicines Agency (EMA) under the Centralised Procedure is underway, with full regulatory submission of blarcamesine expected in Q4 2024. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.[1]
Analysis of RNA sequencing (RNA-seq), which would reveal which genes are actively transcribed (expressed) in Alzheimer’s patients in comparison between placebo and blarcamesine of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease. This data might have relevant value since it may provide insight into Alzheimer’s disease pathology and how cells function in presence of placebo or in presence of blarcamesine, respectively. Interim data expected in the second half of 2024.
Completed last patient last visit in the ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.
AAIC 2024 meeting resulted in constructive feedback received coupled with enthusiasm around our Alzheimer’s disease program strengthened by the recent addition of an experienced clinical team, which support Anavex future plans. Educational reach out to continue towards MAA submission and beyond.
Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical trial of ANAVEX®3-71 for the treatment of schizophrenia has completed dosing of the first cohort and is nearing the completion of enrollment of the second cohort of schizophrenia patients in Part A of the trial.
Parkinson’s disease: Initiation of ANAVEX®2-73 Phase 2b/3 >6-month trial, including biomarkers, which we believe may be key to understanding drug effects on Parkinson’s disease