Replies to post #161445 on Anavex Life Sciences Corp (AVXL)

[TTTav66]

Thanks for this tradeherpete! One correction is that in his last statement he is referring to The Alzheimer's Precision Medicine Initiative (APMI).

The Alzheimer’s Precision Medicine Initiative (APMI) is an international collaboration of leading interdisciplinary clinicians and scientists devoted towards the implementation of PM in Neurology, Psychiatry and Neuroscience.

You can download a paper giving an overview of their work and mission here: https://www.researchgate.net/publication/313540863_A_Precision_Medicine_Initiative_for_Alzheimer's_disease_the_road_ahead_to_biomarker-guided_integrative_disease_modelin

And in an interesting side note, Dr. Hampel pointed out in a tweet last week that Janet Woodcock (Director of Center for Drug Evaluation and Research(CDER)) co-authored this paper with them earlier this year: https://www.sciencedirect.com/science/article/abs/pii/S1043661817313300

Janet Woodcock speaking on biomarker qualification:

[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.

[bas2020]

Certainly, it's good to know about the S1R and COMT variants, etc, to acquire greater knowledge, but given the safety profile of A2-73, and in light of the ineffective treatments that exist today, A2-73 should be given to EVERYONE who is diagnosed with AD...or any CNS disorder, for that matter. Variant or no variant, it just might help!