Anavex Life Sciences Corp (AVXL)

[Investor2014]

A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study

As far as I am aware the stratification to include the APOE3 alleles has not been mentioned in any previous presentations from Anavex. The only difference between Group 1 and 2 is the APOE3 alleles, which appears to make a very significant difference to response, much more so than the SIGMAR1 and COMT variants vs. wild type analysis.

Why was APOE3 alleles not highlighted in the initial KEM Analysis?

Comparing Group 1 to Group 3, it seems clear that the APOE3 alleles are far more significant to response than SIGMAR1 variants vs. wild type.

Of note is also that COMT does not figure in any of the groups. Similarly APOE3 alleles do not figure in the table 2a analysis?

The KEM Analysis approach is great, but to me it is a concern that we only have these findings in such a small trial that we end up with subgroups consisting of 2 patients.

What does this all mean for the Anavex Precision Medicine strategy as it applies to A2-73 - this is a good question, which I can't answer.

Btw. yesterday checking clinicaltrials.com there is no pre-specified subgroup analysis mentioned for PDD, but for Rett and AD only. Missling has however mentioned several times that all trials would have the pre-specified subgroup analysis, so perhaps also including APOE variants.

All we can do is wait and hope for a good PDD readout and yet again for more clarity, perhaps...