Anavex Life Sciences Corp. has revealed promising outcomes from its Phase 2b/3 trial of blarcamesine (ANAVEX®2-73), targeting early Alzheimer's disease. The trial demonstrated a statistically significant slowing in cognitive decline, a hallmark of Alzheimer's progression. This clinical effect was supported by two independent biomarkers: a significant reduction in pathological amyloid beta levels in plasma and a notable slowing in the rate of pathological brain atrophy observed through MRI scans.
The study, conducted across 52 medical research centers in 5 countries, involved 508 participants with early symptomatic Alzheimer's disease. Participants were randomized to receive either blarcamesine or a placebo orally once daily for 48 weeks. The trial met its co-primary endpoints, showing significant differences in cognitive decline and brain atrophy rates between the treatment and placebo groups.
Blarcamesine's efficacy was further underscored by its impact on validated biomarkers of amyloid beta pathology and its ability to significantly reduce brain volume loss. The safety profile of blarcamesine was also highlighted, with common adverse events being mostly mild to moderate in severity.
Experts in the field have expressed optimism about the potential of blarcamesine as a new, convenient oral treatment option for Alzheimer's disease, emphasizing its clinical benefits on cognition and neurodegeneration. The findings from this trial represent a significant step forward in the development of therapies that target the disease beyond amyloid, offering hope for slowing the progression of Alzheimer's disease in its earliest forms.