Anavex’s trial of ANAVEX 2-73 demonstrated slowing in cognitive decline

Anavex Life Sciences announced that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine did demonstrate a statistically significant slowing in cognitive decline associated with Alzheimer’s disease. The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma, as well as a significant slowing in the rate of pathological brain atrophy on MRI scans. All prespecified clinical endpoints were analyzed using a mixed model for repeated measures. The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation. The trial was successful, since the differences in the least-squares mean change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 for ADAS-Cog13, and -0.456 for CDR-SB in patients with early Alzheimer’s disease. In addition, validated biomarkers of amyloid beta pathology, plasma Abeta42/40 ratio increased significantly demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while MRI revealed significant reduction in brain volume loss, including whole brain, comparing treatment to placebo. In the respective safety population, common treatment-emergent adverse events included dizziness, which was transient and mostly mild to moderate in severity, and occurred in 120 participants during titration and in 76 participants during maintenance with blarcamesine and 10 during titration and 9 during maintenance with placebo.