$AVXL Preview of Phase 2b/3for ANVEX 2-73.

The Press Release said ……

Since I crunched the numbers only for MMSE scores I will stay with these however they are flawed.  From November 2017 we have data for all the 26 patients in Phase 2a for ANAVEX 2-73.  With two exceptions, all the patients with positive delta MMSE score are located in the High Concentration Cohort.  The rest of patients suffered decline one way or another and are distributed in all the cohorts but almost exclusively in Medium and Low Concentration.

Since the july 25, 2018 Press Release stated that:

• Including participants with milder disease (baseline MMSE ≥20) and excluding those with a SIGMAR1 variant resulted in an average improvement of +1.7 MMSE and +3.9 ADCS-ADL at week 57 compared to baseline.
• The additional exclusion of participants with the COMT variant resulted in a score improvement of +2.0 MMSE and +4.9 ADCS-ADL at week 57 compared to baseline.

Let’s parse it.  “Baseline MMSE>=20”, from the presentation at CTAD 2017 we know that all the Strong Performers are in this set. These are patients: 2010, 1013, 2006, 1014 and 2008. Their combined average improvement is +2.5.  Since this score is above +2.0 MMSE a patient or patients with negative scores must be added to the set in order to lower the average.

Candidates are:

If we add patient 1007 then average is +1.8 MMSE

If we add patients 1003 and 1009 (odd man out in Low Concentration Cohort)  then average is +2.1 MMSE

If we add patients 3001 and 1009 the average is +1.8

All other patient at 57 weeks are too far advanced in decline to be added and have the average hold about +2.0 MMSE.

We don’t know the initial MMSE scores for all other patients, only 6 strong, from that one can infer that the other patient average initial score was 20.6.

The conclusions, however flawed they are, indicate that:  the ratio of declining to improving patients should range from

1:7   to   1:5

This is for the selection criteria in Phase 2b/3.