Anavex reports follow-on analysis data from its Phase IIb/III study of blarcamesine in early AD


On 14 September, Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease (AD), announced findings from a follow-up analysis to its Phase IIb/III study investigating blarcamesine in people with early AD. The trial was a randomised, double-blind and placebo-controlled study that enrolled 508 participants with early symptomatic AD in Australia, Canada, Germany, Netherlands and UK. Participants received blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks. The Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscales were used as primary end points to assess the cognitive and functional efficacy of blarcamesine. The trial was successful in meeting the co-primary endpoints.

The company bolstered these clinical findings with two independent biomarkers data. The follow-up analysis demonstrated a significant reduction in pathological amyloid-ß levels in plasma, as well as a significant slowing in brain volume loss, when blarcamesine was compared with placebo. When it came to safety, the most common treatment-emergent adverse event was dizziness, which was transient and mostly mild to moderate in severity. Participants who completed the trial were able to enrol in an ongoing open-label extension study, called ATTENTION-AD, where they all receive blarcamesine for about two years. The study is expected to finish next year.