Anavex Life Sciences Corp (AVXL)

[Investor2014]

16 of 21 patients in the 57 weeks peer reviewed data were also on donepezil.

In addition to parameters identified at week 57 (ANAVEX2-73 concentration levels, baseline MMSE score, SIGMAR1 p.Gln2Pro, and COMT p.Leu146fs variants), age, sex, APOE ??4 genotype status, and donepezil co-medication were included in the LME models of change in MMSE and change in ADCS-ADL. Observed genotypes of APOE for patients included in model are presented in Table 2c.
This analysis showed that the higher blarcamesine (ANAVEX2-73) mean concentration arm had improved therapeutic responses of 78% and 88% in adjusted MMSE and adjusted ADCS-ADL, respectively, relative to the low/medium arm at 148 weeks (P-values < .0008 and <.0001, respectively). In addition to time, APOE ??4 status (P < .0001), and blarcamesine (ANAVEX2-73) mean concentration were significant predictors (Figure 2a and 2b and Supplementary Tables 4b, 4c). Additional significant variables in this model were SIGMAR1 p.Gln2Pro, COMT p.Leu146fs, and APOE4 ??4 status interactions with time.

Notice that donepezil did not show up in the blue analyse results section.

We see the reason for that in Supplementary table 4c, because 16 patients also on Donepezil treatment (=True) had a completely non-Stat Sig p-value of 0,959.



So conclusion is co-administration of stable dose of donepezil makes no difference in response to A2-73!

Time to pack up that idea because donepezil co-administration is allowed also in the P2b/3 trials since it makes no difference to outcomes.