Anavex Life Sciences has announced significant findings from its phase 2b/3 trial of blarcamesine, an
investigational treatment for early Alzheimer’s disease. The trial results
indicate that blarcamesine could play a crucial role in reducing amyloid-ß
biomarkers and slowing neurodegeneration.
Conducted across multiple centers, this double-blind, placebo-controlled study enrolled 508
participants. Patients were randomized to receive either blarcamesine or a
placebo for 48 weeks. The primary endpoints for evaluating the drug’s efficacy
were the Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and the
Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscales.
The results were promising. Blarcamesine-treated patients showed a significant increase in the
plasma Aβ42/40 ratio (P = .048) and a notable reduction in brain volume loss,
including whole brain atrophy (P = .0005). These findings suggest that the drug
effectively targets both cognitive decline and neurodegeneration.
Moreover, the study made by Anavex revealed
a positive impact on cognitive function. The least-squares mean change from
baseline to 48 weeks for ADAS-Cog was −1.783 (P = .0226), indicating a
meaningful cognitive benefit. Additionally, the Clinical Dementia Rating Scale
Sum of Boxes also showed significant improvements with an LS difference of
−0.456 (P = .0175) between the blarcamesine and placebo groups.
Safety profiles were also closely monitored. Dizziness was the most common adverse event,
reported in 35.8% of participants during titration and 25.2% during
maintenance. However, these instances were mostly mild to moderate in severity.
Marwan Noel Sabbagh, MD, chairman of the Scientific Advisory Board, emphasized the drug’s
potential. “Blarcamesine is a small oral molecule that exerts clinical benefits
on cognition and neurodegeneration and could be appealing because of its route
of administration and excellent safety profile,” he stated.
Christopher U Missling, PhD, CEO of Anavex,
expressed optimism about the future of blarcamesine. He highlighted the
company’s commitment to advancing Alzheimer’s treatments and praised the
invaluable contributions of the study participants and researchers.
In summary, Anavex Life Sciences’ blarcamesine shows robust clinical efficacy and a promising
safety profile in treating early Alzheimer’s disease, marking a significant
step forward in Alzheimer’s research. See related link for additional information.
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