One of the biggest unmet needs in the area of biomedical research today lies in the treatment of Alzheimer’s disease, which is growing almost exponentially in all regions of the world. Alzheimer’s is the most common cause of dementia; it accounts for 60-80% of dementia cases in adults over 65, and it is progressive, with symptoms gradually worsening over some years. Longevity Live Paid Content.
In the U.S., Alzheimer’s disease is projected to represent $20 trillion in the cumulative costs of Alzheimer’s and dementia care from 2015 to 2050. One in three Medicare dollars will be spent on Alzheimer’s disease and other dementia in 2050, with 11 million Americans providing unpaid care for people with Alzheimer’s and other dementia.
Blarcamesine: The Foundation for More Cost Effective and Safer Treatments for CNS Conditions
Anavex Life Sciences is a clinical-stage biopharmaceutical company that is developing differentiated therapeutics for the treatment of Alzheimer’s disease and other neurodegenerative disorders. With its recent Phase 2b/3 clinical trial of blarcamesine (ANAVEX 2-73), the company is currently at the leading edge in offering novel and effective treatments for Alzheimer’s.
Results from the trial showed that oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer’s disease patients with goa od comparative safety profile and no associated neuroimaging adverse events.
Anavex is focused on developing small molecule drugs, for Alzheimer’s in particular. Currently in the regulatory submission stage, the company is planning to submit for potential EMA approval in Europe by the end of 2024, with other regions to follow. Blarcamesine has been favorably compared in the industry to the antibody drugs Leqembi and Donanemab; here, blarcamesine demonstrated superiority in both safety and efficacy in early Alzheimer’s patients.
Anavex has also Phase 2 data on blarcamesine for Parkinson’s dementia, for which they also see oral treatment opportunities. The company plans a larger Parkinson’s study in the near future with blarcamesine.
A liquid blarcamesine formulation which is convenient for children and patients who have problems swallowing has been development. This was recently demonstrated during studies involving Rett syndrome, a rare disease. Anavex is planning to also expand this indication franchise of rare disease into Fragile X and other following rare disease trajectories.
Another therapeutic under development by Anavex is Anavex 3-71, an oral treatment for schizophrenia, which affects nearly 24 million people worldwide, including 2.8 million people in the U.S. Anavex 3-71 is currently in ongoing Phase 2 trials. New research into the genetic underpinnings of schizophrenia has revealed links between this psychiatric disorder and Alzheimer’s disease, suggesting the disorders may share certain mechanisms.
Clinical and Financial Stability Moving Forward
Based on information and data shared at the company’s recent investor’s meeting, Anavex is well-positioned to expand its transformative precision medicine platform and capitalize on significant market opportunities. Its precision medicine platform and novel central nervous system mechanism involves activation of upstream, endogenous pathways which counter neurodegeneration.
To date, the company has realized multiple clinical milestones and has a promising pipeline with potential progress toward commercialization on several fronts. Its strong financial profile should readily support operations, and its clinical programs are funded for the next several years. It has a sufficient cash runway due to disciplined operations and non-dilutive cash sources, such as Michael J. Fox Foundation, the International Rett Syndrome Foundation and the Australian government.
Anavex Life Sciences is clearly making substantial strides in addressing the needs of Alzheimer’s treatment and other CNS disorders. With the promising results of blarcamesine in early Alzheimer’s disease and its potential application to conditions like Parkinson’s dementia and Rett syndrome, the company is poised to make a significant impact on central nervous system treatments. The development of Anavex 3-71 for schizophrenia further showcases the company’s broad and innovative pipeline.
End note
With ongoing clinical trials, strong financial backing and a precision medicine platform that could revolutionize the treatment of CNS disorders, Anavex is well-positioned for continued success. As the company moves towards potential regulatory approval for blarcamesine in Europe and beyond, it is clear that Anavex’s innovative therapies could reshape the landscape of neurodegenerative disease treatment, offering new hope to millions of patients across the globe.
