Anavex Life Sciences has announced findings from its Phase IIb/III Alzheimer’s trial in which 30 mg daily oral blarcamesine led to cognitive outcomes in a “Precision Medicine” population (called ABCLEAR3) that the company says approximate normal aging rather than typical Alzheimer’s decline. The results cover 48 weeks in early Alzheimer’s disease patients with progressed pathology.
On the standard ADAS-Cog13 scale, the company reports a mean change from baseline of 0.853 points in the treatment group, compared with around a 1-point annual decline seen in prodromal (pre-dementia) aging adults. On the CDR-SB scale, it reports a 0.465 change, consistent with annual decline rates of 0-0.5 points in prodromal aging.
The placebo group in the same trial reportedly declined by 5.592 points on ADAS-Cog13 over 48 weeks, leading to an 84.7% reduction in decline with blarcamesine versus placebo on that cognitive endpoint. The company says up to ~70% of early Alzheimer’s patients globally may benefit under this Precision Medicine approach, targeting patients with non-mutated SIGMAR1 and COL24A1 gene variants.
Anavex also reiterates that blarcamesine acts via restoring autophagy through SIGMAR1 activation, an upstream target distinct from amyloid and tau pathology. The company says safety remains favourable. Further data will be submitted for publication and presentation at international Alzheimer’s conferences.
