High Concentration Cohort Phase 2a Anavex 2-73 (continued)….

Just don’t, It isn’t worth it!

Only $3 Bills Accepted

$3.00

I have plotted the data from CTAD 2017 presentation together with some linear extrapolation from the 57 week data and computed certain averages.  Once you do this you get the instantaneous insight into the data, it is amazing.  Here is the plot:Anavex 2-73 Phase2a Results Plot.png

From top are:
1. High Concentration Ascending (4 patients)
2. High Concentration Initially Better (2 patients)
3. Average for High Concentration Cohort (10 patients)
4. Progress of Alzheimer Disease as reference from previous post
4. High Concentration Descending (4? patients) (?=dropouts)

Lines at 30, 24, 16 and 6 delineate MMSE scores ranges named Mild, Moderate and Severe (from top). 30 is top score called Healthy.

There is plenty of insight here, but I will limit myself to the essential ones.  Is there an indication of efficacy?  When you get the average score for all groups (High Average) in the cohort, and then compare it with referenced Natural Course labeled line you notice that the difference is amounting to ~2.5 MMSE point per year. Over 4 years that is 10 points, this might make the difference for many not to have requiring expensive care. This result includes all groups and encompasses those who are going really fast  below 16 towards 6 points.

The line with label (High Descending) shows the group of patients for whom there is no therapeutic outcome.  The line is extrapolated from one year data and shows quick descent into Severe range, probably dropouts from trial accelerate afterwards.  This phenomenon validates normalizing data in  previous post.

As I had pointed out in previous post there was some selective action on those healthier than the average and it showed in the average score for two other groups. The higher average the stronger effect. If this would be the only criteria, since we don’t know and have no way of knowing because have only partial raw data, there would be no need for genetic and phenotype inquiry and establishing correlations with the effect.  This inquiry will either/and validate the data or discover some needed criteria for ITT (Intent To Treat) population.

If ~50% patients of 5 million will never go to institutions or will show no need of specialized care at home then we look at (3 years stay, $30k/year) about 200 billion savings to taxpayer and families (1.1% of GDP). This reminds me of Louis Pasteur’s invention of rabies vaccine which created so much wealth in France that it defrayed all the cost of war reparations to Prussia after 1870.

In the High Ascending data set I included patient 101009 who improved greatly though did not show high concentration in blood. This could be explained by heterogeneity with propensity of clearing Anavex 2-73 at higher rate than normal which does not preclude therapeutic effect.

One more thing, at one year of  observation the values for decline starting at 21 MMSE score and Standard Deviation for Natural Course of Progress were 17.2 +/-4.3,  and the same for High Concentration Average were 19.6 +/-5.9.  That was 138% of SD for Natural, either we are having just so, as it happens, larger dispertion in data and it should be dismissed, or this discrepancy is due to bifurcation (selective therapeutic action of the drug) i.e. the area on which 68% of data resides is increased.

 

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