Anavex Life Sciences has announced encouraging results from a Phase 2b/3 clinical trial of
their investigational oral therapy, Anavex 2-73 (blarcamesine), targeting early
Alzheimer’s disease. The therapy appears to significantly decelerate cognitive
and functional decline, a breakthrough in treating this debilitating condition.
The study enrolled 509 participants aged 60-85 with mild cognitive impairments or mild dementia
due to Alzheimer’s. Participants were administered either one of two doses of
Anavex 2-73 or a placebo over 48 weeks. The primary focus was on assessing
cognitive improvements using the Alzheimer’s Disease Assessment Scale-Cognition
(ADAS-Cog) and overall functional ability via the Alzheimer’s Disease
Cooperative Study-Activities of Daily Living Scale (ADCS-ADL).
Top-line data revealed that patients treated with Anavex 2-73 experienced an 84% higher
likelihood of meaningful cognitive improvement and a 45% slower cognitive
decline compared to those on a placebo. Additionally, the treatment
demonstrated a 167% greater chance of significant functional improvement.
Anavex 2-73 works by activating the sigma-1 receptor, a brain protein implicated in
neuroprotection. This activation helps prevent toxic protein buildup and
reduces neuroinflammation and oxidative stress, which are characteristic of
Alzheimer’s. The therapy also showed benefits in reducing brain volume loss and
improving the ratio of amyloid-beta protein forms, crucial markers of the disease.
The treatment was generally well tolerated, with dizziness being the most common side effect.
Participants completing this trial have the option to join an open-label
extension study, offering continued access to Anavex 2-73 for an additional two years.
Anavex Life Sciences is planning discussions with regulatory authorities in the U.S.,
Europe, and Asia-Pacific to seek approval for Anavex 2-73, potentially making
this a new, convenient option for Alzheimer’s patients worldwide. As research
continues, Anavex remains dedicated to developing solutions for neurological
conditions, including Rett syndrome and Parkinson’s disease.
Read this article for related information.