ANAVEX 2-73 after July 25th

Every time there is a news release the data provided is formated in different way and there are things omitted  so if somebody tries to get to the bottom of it he has to make assumptions.  I have the deep seated impression that he company strategically refrains from spilling the beans on ANAVEX 2-73.  It gingerly threads between making us believe “we have the cure!” and “it is just another Alzheimer trial”.  I have the impression that even Phd readers who have seen too many of these to fail are kept in this camp too.

I have to confess that I tried to get to the bottom of the format of the data presented by AVXL but ultimately gave up hence my remark about Phd part of humanity.  I can infer certain things but only at the peril of making assumptions and even then there are holes in the logic through which one can drive a decent size car, but not a truck.

The only to two parts of this poster I can relate to square with the data from other releases, that is the beginning and the conclusions of the poster.  The rest is like: oh! look green bar is higher than the orange so it must be good! 

AAIC_Anavex_Gene_poster_2018_Final-.png

 

From the red square on the left, I learned that by second year the number of patients still in trial, since at the data dump after 57 weeks that number was 26, is now 21 patients with one patient an odd man out, which I would identify as patient number 1009, who probably had been was wrongly diagnosed.  The other piece of info is that varying doses are kept into the extension and that there can be patients with doses below 14mg/Kg, that previously had been determined to be minimum therapeutic dose. Trials like this have natural rate of dropouts I used reference given in post (link):  ANAVEX 2-73 Phase 2a vs. Alzheimer’s Progress

In this post I made assumptions to format the data consistent across the reference on Natural Progression of Disease and Phase 2a data.  This bit of information has confirmed correctness of my assumption.  Let us plot this for both trials:

Dropout for Phase 2a .png

 

Green line gives the number of participants as in the reference study, red line the same for Phase 2a and the purple is projection if the number stay the same till now.

The population ITT (Intent To Treat) is 62% of overall Alzheimer population multiplied by .80 of those still in the trial.  So we are looking at 50% of Alzheimer total population as ITT population for ANAVEX 2-73.

Performance of this population is said to be Δ=+2 MMSE (Avg) @57 weeks(?) by comparison for the six patients (Strong) whose data was released up to 109 weeks in CTAD November 2017 presentation this metric was Δ=+2.5 MMSE (Avg) @57 weeks.  Also The average MMSE score for the predisposed group at start of trail was >= 20 so compared with six patient (Strong) MMSE=22 implies lesser performance since the starting score is a bit lower. See previous post for remarks on these and other aspects of the expected performance of ANAVEX 2-73.

My scratch pad is posted here so you cna check my work.

AAIC 2018 Page 1.png

 

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