On 1 January, Anavex Life Sciences Corp, a clinical-stage biopharmaceutical company focused on developing innovative treatments for neurodegenerative diseases such as Alzheimer's disease (AD), released the results from its IIb/III ANAVEX2-73-AD-004 trial investigating blarcamesine for the treatment of early AD. Published in The Journal of Prevention of Alzheimer's Disease, the findings provide insights into the potential of blarcamesine in slowing clinical decline in people with early AD. The Phase IIb/III trial, ANAVEX2-73-AD-004, was a randomised, double-blind and placebo-controlled study that involved 508 participants from five countries: Australia, Canada, Germany, Netherlands and UK. Participants received once-daily oral doses of either blarcamesine (30 or 50 mg) or a placebo for 48 weeks.
The co-primary outcomes were reduction in cognitive decline using the 13-item Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog13) and reduction in decline of the ability to perform daily activities, using the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Scale. The secondary outcome was the reduction in cognitive and functional decline measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The results showed that blarcamesine significantly slowed clinical progression at 48 weeks compared to placebo in the prespecified primary endpoint ADAS-Cog13 and the prespecified secondary endpoint CDR-SB, while the co-primary endpoint ADCS-ADL did not reach statistical significance at Week 48. Blarcamesine demonstrated a safety profile with no associated neuroimaging adverse events These findings have contributed to the European Medicines Agency (EMA) accepting Anavex's Marketing Authorization Application (MAA) for blarcamesine for the treatment of AD. This MAA submission is supported by data from the Phase IIb/III trial and the open-label extension ATTENTION-AD study.
To access the press release, visit: https://www.anavex.com/post/blarcamesine-receives-ema-filing-acceptance-for-treatment-of-alzheimer-s-disease
You can download the published paper here: https://doi.org/10.1016/j.tjpad.2024.100016