Anavex Life Sciences Corp (AVXL)

[Doc328]

Since the A273 trial did not measure amyloid SUVr on amyloid PET scans, the CSF and serum biomarkers would need to be considered. The Lecanemab study did measure plasma p-tau181 and found a nice dose-dependent correlation with the PET centiloid change (p=0.037 with a Spearman coefficient but p=0.071 with a more rigid Pearson correlation). Therefore, Anavex would have data from a different company to help support this biomarker.

The CSF biomarker data for lecanemab showed increased Ab1-42 and reduced p-tau with very significant p values, better than plasma (counterintuitively, higher Ab1-42 in CSF is better - retuning towards normal)

https://alzres.biomedcentral.com/articles/10.1186/s13195-022-01124-2

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053280/figure/Fig5/

These 3 biomarkers would need to be significant, consistent and survive multiplicity standards to allow Anavex to argue their use for AA.

I do not think any other serum/CSF biomarker, besides those above, has enough independent evidence to get through the FDA.