Anavex Life Sciences Corp. (AVXL) has revealed promising results from its Phase IIb/III study on blarcamesine (ANAVEX 2-73), an oral medication administered once daily. The study indicates that blarcamesine significantly slows clinical decline in individuals with early-stage Alzheimer's disease (AD).
According to Anavex, blarcamesine reduced clinical progression by 38.5% and 34.6% in the 50 mg and 30 mg groups, respectively, compared to the placebo group over 48 weeks, based on the ADAS-Cog13 cognitive endpoint. Although the ADCS-ADL functional endpoint showed a positive trend, it did not achieve statistical significance at the 48-week mark, which may be attributed to the scale's design for overt dementia rather than early-stage AD.
Furthermore, the pre-specified key secondary composite endpoint, CDR-SB, recommended by the FDA's new guidance as an alternative primary endpoint for early AD, showed significant results at both dosages at the 48-week interval. These outcomes are corroborated by biomarkers from the A/T/N spectrum, including the plasma Aß42/40 ratio and reduction of brain atrophy. Notably, blarcamesine significantly mitigated brain atrophy in crucial regions, decreasing total brain atrophy by 37.6%, total grey matter by 63.5%, and atrophy in the lateral ventricles by 25.1%.
Blarcamesine's safety profile suggests that routine MRI monitoring is unnecessary. Given its distinct mechanism of action, blarcamesine could complement currently approved anti-beta amyloid monoclonal antibody treatments.
Anavex anticipates submitting a full regulatory application for blarcamesine to the European Medicines Agency (EMA) in the fourth quarter of 2024.
