Anavex Life Sciences Announces EMA Acceptance of Blarcamesine MAA for Alzheimer's Treatment
Key Insights
The European Medicines Agency (EMA) has accepted Anavex's Marketing Authorization Application (MAA) for blarcamesine to treat Alzheimer's disease (search).
Anavex presented Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial data at the J.P. Morgan 2025 Healthcare Conference.
Preliminary Phase 2 clinical study results of ANAVEX3-71 for schizophrenia (search) showed a dose-dependent effect on key EEG biomarkers.
Anavex Life Sciences Corp. (Nasdaq: AVXL) has announced the European Medicines Agency (EMA) acceptance for review of the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer's disease (search). This marks a significant step forward in potentially bringing a novel, orally-dosed treatment option to the millions affected by Alzheimer's in Europe.
Blarcamesine's Potential in Alzheimer's Treatment
Christopher U Missling, PhD, President and Chief Executive Officer of Anavex, expressed enthusiasm about the potential of blarcamesine to advance a novel treatment for early Alzheimer's disease (search) with convenient oral dosing. He highlighted the team's commitment to making a difference for individuals suffering from Alzheimer's disease by presenting a scalable treatment alternative alongside the ease of oral administration.
Blarcamesine is designed to restore cellular homeostasis by targeting SIGMAR1 (search) and muscarinic receptors. Preclinical studies have demonstrated its potential to halt or reverse the course of Alzheimer's disease (search). The drug has also shown anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, suggesting its potential to treat additional CNS disorders.
Clinical Data and Upcoming Presentations
Anavex presented topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference in San Francisco, CA. The company also participated in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL.
New data from the Phase IIb/III study, presented at the Clinical Trials on Alzheimer's Disease (search) (CTAD) conference in Madrid, Spain, showed that blarcamesine, administered orally once daily, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 (search) activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease.
ANAVEX3-71 for Schizophrenia
Anavex also announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX3-71 for the treatment of schizophrenia (search). Preliminary results demonstrated a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers in patients with schizophrenia. Data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, is expected in the first half of 2025.
Financial Position
Anavex reported a strong financial position with cash and cash equivalents of $132.2 million as of September 30, 2024, compared to $151.0 million at September 30, 2023. The company anticipates a cash runway of approximately 4 years at the current cash utilization rate. For the fourth quarter, general and administrative expenses were $2.8 million, and research and development expenses were $11.6 million. The net loss for the quarter was $11.6 million, or $0.14 per share, compared to a net loss of $10.1 million, or $0.12 per share, for the comparable quarter of fiscal 2023.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a biopharmaceutical company focused on developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease (search), Parkinson's disease (search), schizophrenia (search), Rett syndrome (search), and other central nervous system (CNS) diseases.