Anavex’s New Analysis of Alzheimer’s Pill Shows Mixed Results

1. Mixed Results: Anavex's new analysis of its Alzheimer's pill, blarcamesine, showed mixed results, with significant slowing of clinical progression but only meeting one of the two co-primary endpoints.
2. Phase IIb/III Trial: The Phase IIb/III trial enrolled 509 patients across sites in Australia, Canada, and Europe, with patients monitored for 48 weeks of the once-daily oral drug.
3. Clinical Efficacy: Blarcamesine significantly slowed clinical decline by 38.5% and 34.6% at 48 weeks in 50mg and 30mg groups versus placebo, respectively, on the prespecified primary cognitive endpoint Alzheimer's disease assessment scale–cognitive subscale 13 (ADAS-Cog13).
4. Neurodegeneration: The drug showed a significant reduction in pathological amyloid beta levels in plasma and a significant slowing in the rate of pathological brain atrophy on MRI scans.
5. EMA Approval: Anavex plans to submit an application to the European Medicines Agency (EMA) for approval of blarcamesine despite the mixed results.
6. Comparison to Other Therapies: Blarcamesine compares favorably to other Alzheimer's disease treatments, including anti-amyloid therapies like lecanemab and donanemab.
7. Future Developments: Anavex is also investigating blarcamesine in Rett syndrome and Parkinson's disease, with ongoing trials and promising preclinical results.