Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)

2023-11-21

研发

临床2期临床3期临床结果

Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and

neurodevelopmental disorders

announced today that representatives of Anavex met with team members of the European Medicines Agency (EMA).

These meetings discussed the debilitating pathology of

Alzheimer’s disease

and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.

Anavex’s goal is to take care of patients in a patient-centric way with the preference for convenient oral treatment options for Alzheimer’s disease not requiring complex logistics resources and added personnel for drug administration and monitoring for

brain edema

and

brain bleeds

Severe symptoms in relation to

Amyloid-Related Imaging Abnormalities (ARIA)

is a known risk factor for Alzheimer’s patients taking the class of drugs called monoclonal antibodies, and requires constant and repeated MRI examination, for which not all regions in Europe are currently sufficiently prepared and equipped for in addition to the requirement to address affordability and inequalities in patient access within European Union countries.1,2

“We look forward to working together with the team from EMA,” said David Goldberger, RPh, MLS, Senior Vice President Regulatory Affairs at Anavex. “We continue to work towards fulfilling our purpose of improving patients' lives with oral blarcamesine not requiring any complex additional procedures for the treatment of people with 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.3

The World Health Organization (WHO) estimated the cost in Europe of caring for people with

dementia

, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.4,5

“There remains an urgent need for convenient once-daily oral treatment options for Alzheimer’s disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making,” said Christopher U Missling, PhD, President and Chief Executive Officer at Anavex.

In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.

Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease,

Parkinson's disease

Rett syndrome

, and other

central nervous system (CNS) diseases

pain

, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with

Rett syndrome

. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including

epilepsy

. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets

sigma-1

and

M1 muscarinic receptors

, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.

1 Frölich L, Jessen F. Editorial: Lecanemab: Appropriate Use Recommendations - A Commentary from a European Perspective. J Prev Alzheimers Dis. 2023;10(3):357-358. doi: 10.14283/jpad.2023.44. PMID: 37357274.

2 Jönsson L, Wimo A, Handels R, Johansson G, Boada M, Engelborghs S, Frölich L, Jessen F, Kehoe PG, Kramberger M, de Mendonςa A, Ousset PJ, Scarmeas N, Visser PJ, Waldemar G, Winblad B. The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer's disease: an EADC-EC viewpoint. Lancet Reg Health Eur. 2023 May 22;29:100657. doi: 10.1016/j.lanepe.2023.100657. PMID: 37251789; PMCID: PMC10220264.

3 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

4 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.

5 World Health Organization (WHO); 2021. Global status report on the public health response to dementia.

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