On 28 July, Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease (AD), presented findings from its Phase IIb/III study at the Alzheimer's Association International Conference (AAIC). The trial included 508 participants with mild dementia or mild cognitive impairment due to AD, aged 60 to 85 years old. They were randomly assigned to receive the experimental drug blarcamesine (30 or 50 mg), or a placebo, once daily for 48 weeks. The study’s main goals were to evaluate the benefits of blarcamesine on cognition, using the Alzheimer’s Disease Assessment Scale-Cognition (ADAS-Cog13) and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) as co-primary endpoints. Researchers found that blarcamesine significantly slowed cognitive decline by 34.6% at the 30 mg dose and by 38.5% at the 50 mg dose compared to placebo on ADAS-Cog13 at week 48.
No significant differences were observed in ADCS-ADL scores. Findings also showed that blarcamesine significantly slowed cognitive worsening by 28.6% at the 30 mg dose and by 26.5% at the 50 mg dose compared to placebo at week 48 on the prespecified key secondary composite endpoint, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). Blarcamesine was relatively safe with no associated neuroimaging adverse events. Additionally, blarcamesine significantly slowed brain atrophy in key regions of interest, including the whole brain, total grey matter and lateral ventricles. The company is planning to publish data in an upcoming peer-reviewed journal. Full regulatory submission of blarcamesine in Europe is expected in Q4 2024.
