EMA Accepts Blarcamesine Filing for Alzheimer's Treatment

Anavex Life Sciences Corp. has made strides in the fight against Alzheimer's disease with the European Medicines Agency (EMA) accepting the Marketing Authorization Application (MAA) for blarcamesine, also known as ANAVEX®2-73. This investigational drug is an oral treatment aimed at slowing down the progression of Alzheimer's by enhancing autophagy, a cellular mechanism. The acceptance of the MAA marks a significant milestone for Anavex, as it moves closer to offering a novel treatment option for Alzheimer's patients in Europe.

Blarcamesine has shown promise in clinical trials, particularly in early Alzheimer’s patients. In a Phase IIb/III trial, the drug was administered once daily and demonstrated an ability to meaningfully decelerate clinical decline without causing neuroimaging adverse events. This suggests a favorable safety profile and a potential shift in how Alzheimer's is managed, focusing on upstream pathology through the activation of autophagy.

The MAA is supported by data from a randomized, double-blind, placebo-controlled trial, as well as an open-label extension study involving patients with early Alzheimer's disease. The results, recently published in a peer-reviewed medical journal, underscore the drug's efficacy in targeting Alzheimer's pathology by activating SIGMAR1, a protein involved in cellular homeostasis. Moreover, a five-year Phase 2a trial provided additional evidence, utilizing artificial intelligence to identify genomic biomarkers predictive of a positive response to blarcamesine.

Anavex’s clinical development program has highlighted blarcamesine's potential as a pioneering treatment for Alzheimer's. Unlike existing therapies, this drug could serve as an alternative or complement to injectable anti-beta amyloid monoclonal antibody treatments, offering a simpler oral administration route. The drug’s mechanism of action, which includes the induction of autophagy through SIGMAR1 activation, tackles neurodegeneration before amyloid beta and tau tangles fully develop, making it a potentially preventive measure against the disease.

Statistics from the European Brain Council highlight the urgency of such treatments, with approximately 7 million people in Europe currently living with Alzheimer's. This figure is expected to double by 2030, underscoring the need for innovative approaches to treatment. The economic burden of dementia, including Alzheimer's, is also significant, costing Europe an estimated $439 billion annually as per the World Health Organization. These costs cover a wide range of healthcare and caregiving expenses, underlining the importance of effective therapeutic solutions.

Anavex Life Sciences Corp., a biopharmaceutical company listed on Nasdaq as AVXL, is dedicated to developing treatments for a range of neurodegenerative and neuropsychiatric disorders. Blarcamesine, its lead candidate, has undergone extensive clinical evaluation for Alzheimer's, Parkinson’s disease dementia, and Rett syndrome. The drug has demonstrated not only potential in halting Alzheimer's progression but also exhibited properties beneficial in treating other central nervous system disorders.

The company remains committed to advancing blarcamesine's development and maximizing patient access to this innovative therapy. The progress with the EMA is a crucial step in this journey, reflecting Anavex’s ongoing dedication to improving outcomes for individuals living with Alzheimer’s and other CNS disorders.