Anavex Submits Blarcamesine MAA for Alzheimer's Treatment to EMA

Anavex Life Sciences Corp., a clinical-stage biopharmaceutical firm focused on developing unique treatments for various central nervous system diseases, has announced a significant milestone. The company has submitted its Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73) to the European Medicines Agency (EMA) for the treatment of Alzheimer’s disease.

Blarcamesine is an orally administered small molecule intended to be taken once daily. It has shown clinically significant improvement over 48 weeks, with primary endpoint ADAS-Cog13 scores improving by more than two points. This indicates a superior clinical efficacy compared to currently approved therapies and suggests a potential to slow neurodegeneration in early Alzheimer's patients. An added benefit of blarcamesine is its safety profile, which does not necessitate routine MRI monitoring. Its oral administration makes it a convenient treatment option, potentially enhancing its appeal due to ease of use and safety.

There are approximately seven million individuals in Europe afflicted with Alzheimer’s, a figure predicted to double by 2030, as per the European Brain Council. The World Health Organization has estimated the 2019 cost of caring for individuals with dementia, including Alzheimer’s, in Europe to be $439 billion, averaging $31,144 per person. These costs encompass a range of services and care, including hospital care, medication, diagnostics, caregiver time, community services, and long-term care facilities.

Dr. Juan Carlos Lopez-Talavera, Head of Research and Development at Anavex, stated that the MAA submission is a pivotal step in the journey to provide this novel therapy to Alzheimer’s patients globally. He highlighted the potential of blarcamesine’s safety and efficacy profile to serve as an innovative treatment, either as a complementary option or an alternative to existing anti-beta amyloid monoclonal antibody drugs.

Christopher U Missling, President and CEO of Anavex, echoed these sentiments, calling the regulatory submission in the EU a significant milestone. He expressed gratitude towards all participants, especially the families involved in the clinical development program. He acknowledged that oral blarcamesine has shown potential in slowing the progression of Alzheimer’s, a relentless and ultimately fatal disease.

Anavex Life Sciences Corp. is a publicly traded biopharmaceutical company dedicated to creating novel therapeutics for a range of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders including Alzheimer’s, Parkinson’s, and Rett syndrome. Their leading drug candidate, ANAVEX®2-73 (blarcamesine), has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer’s, and various clinical studies for Parkinson’s dementia and Rett syndrome in both adult and pediatric patients. The drug is designed to restore cellular balance by targeting SIGMAR1 and muscarinic receptors, with preclinical studies showing its potential to halt or reverse Alzheimer’s progression. ANAVEX®2-73 has also demonstrated anticonvulsant, anti-amnesic, neuroprotective, and antidepressant properties in animal models, suggesting its potential for treating additional CNS disorders like epilepsy.

Furthermore, Anavex's other significant drug candidate, ANAVEX®3-71, also targets SIGMAR1 and M1 muscarinic receptors and has shown promise in preclinical trials against the main hallmarks of Alzheimer’s disease, including cognitive deficits, amyloid, and tau pathologies. Its beneficial effects on mitochondrial dysfunction and neuroinflammation highlight its potential as a disease-modifying treatment. The Michael J. Fox Foundation for Parkinson's Research has previously funded a preclinical study for ANAVEX®2-73 aimed at treating Parkinson's disease.

Anavex continues to push forward in its mission to develop and deliver new treatments for CNS disorders, with their latest submission for blarcamesine representing a crucial step towards potentially providing a novel oral therapy for Alzheimer’s disease in the European market.