Anavex Life Sciences Corp (AVXL)

[Doc328]

So in the upcoming large scale P2b/3 study, in 450 patients with early AD, we are planning to look at 2 aspects again, stratification regarding the genomics of the patients. We look at Wild types of the S1R gene carriers vs variant receptor carriers. And we expect a differential response depending on the genetic background.

So, it looks like they will be enrolling all genetic types. Thus, about 360 patients will be S1R-WT and about 90 patients will be S1R-var. Then at study end they will analyze the data stratified by the gene.

The proposed P2/3 looks well designed (placebo controlled, randomized, standard outcomes such as ADAS-cog and CDR-SB, etc)and should be large enough to get real data. I look forward to those results. The only thing I don't like about the study is that they have MMSE 20-28 as inclusion criteria (based on HH's slide at AAIC) and many MMSE 27 and 28 (MCI not mild AD) patients would not be expected to decline over 48 weeks. This potentially weakens a treatment effect if the numbers of these patients are too high.