Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company, has announced promising results from its Phase IIb/III trial of blarcamesine (Anavex 2-73) for the treatment of early Alzheimer’s disease. The findings, presented at the 2024 Alzheimer’s Association International Conference, demonstrate that the oral, once-daily medication significantly slowed clinical decline in patients with early Alzheimer’s disease.
The study, which evaluated two dosage groups of blarcamesine (30 milligram and 50 milligram) against a placebo, showed significant improvements in cognitive function and other key measures of disease progression. These results position Anavex as a potential player in the competitive field of Alzheimer’s disease treatments.
Blarcamesine Significantly Slowed Progression of Alzheimer’s disease in Clinical Trial
In the clinical trial, blarcamesine significantly slowed clinical progression as measured by the Alzheimer’s Disease Assessment Scale–Cognitive Subscale, or ADAS-Cog13, a neuropsychological assessment used to measure the severity of cognitive symptoms related to dementia. They slowed by 38.5% in the 50-milligram group and 34.6% in the 30-milligram group at 48 weeks when compared to those who took a placebo.
The key secondary endpoint, the Clinical Dementia Rating-Sum of Boxes, or CDR-SB, showed significant improvement in both dosage groups compared to a placebo. Blarcamesine also demonstrated a significant reduction in brain atrophy, including a 37.6% slowdown in whole brain atrophy, 63.5% in total gray matter, and 25.1% in lateral ventricles.
The drug showed benefits on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease. The most common side effect was dizziness, which was generally mild to moderate and manageable through adjusted titration schedules.
Blarcamesine Could Reduce Barriers to Treatment
Marwan Noel Sabbagh, M.D., professor of neurology and chairman of the scientific advisory board, presented the data at the conference. He emphasized the significance of these results, noting that blarcamesine’s oral administration and favorable safety profile could potentially reduce barriers to treatment for Alzheimer’s.
Anavex’s approach focuses on improving autophagy, a key cellular mechanism responsible for clearing protein aggregates and misfolded proteins in the brain that are associated with AD. This unique mechanism of action distinguishes blarcamesine from other treatments currently on the market.
Juan Carlos Lopez-Talavera, M.D., Ph.D., head of research and development at Anavex, highlighted the company’s precision medicine approach. In a news release, he said that the study results offer hope for patients to maintain their sense of self for longer periods, potentially allowing more time for meaningful activities.
The company plans to submit a full regulatory application to the European Medicines Agency in the fourth quarter of 2024. This move signifies Anavex’s confidence in the drug’s potential and its readiness to move toward market approval.
It’s important to note that while these results are promising, blarcamesine is still an investigational drug. The company cautions that there is no guarantee that it will successfully complete clinical development or gain health authority approval.
Anavex, founded in 2007, is dedicated to developing novel therapeutics for various neurodegenerative, neurodevelopmental, and neuropsychiatric disorders. In addition to Alzheimer’s, the company is exploring treatments for Parkinson’s disease, Rett syndrome, schizophrenia, pain, and various types of cancer.
The positive results from this Phase IIb/III trial represent a significant milestone for Anavex and potentially for the field of AD treatment. If approved, blarcamesine could offer a new option for patients in the early stages of Alzheimer’s, with the convenience of oral administration and a different mechanism of action compared to currently approved therapies.
While these results are encouraging, it’s crucial to remember that further research and regulatory reviews are necessary before blarcamesine can be considered for widespread use.
Note: This article discusses investigational uses of a product in development and does not intend to make conclusions about efficacy or safety. There is no guarantee that blarcamesine will successfully complete clinical development or gain health authority approval.
