Replies to post #424169 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

We know that the AVATAR Rett syndrome trial did you titration because we heard a medical doctor and a parent discussing titration process for his 41 year old daughter at the beginning the OLE study in the UK.

GOD bless,

[gerry57]

So Doc just out of curiosity I googled typical dropout rates for trials and found the the answer to be 20% and it was deemed acceptable, so 4.9 % vs4.7 placebo represents what in this context?

[12x]

Good point Doc. The AD p2b/3 dropout rate in maintenance phase was 5.6%=(11+6)/301 treated vs 4.9% in PDD, and 10.95%=37/338 treated vs 10.2% in PDD. Almost identical to PDD. I don’t have the slide deck for PDD breakdowns to compare, but the percentage of patients not on targeted 30/50mg in AD are high: 55 (33+20) in maintenance phase on top of 75 (338-263) in up titration phase. Some of the 37 titration phase dropouts were from the 75, but 55-130 patients not on targeted dose is high. However, If the PDD has similar percentage of patients not staying on targeted dose but still shown dose significant, it bodes well for PD dose/subgroup analysis?

From the 2020 CTAD PDD presentation:
- Subjects with at least one TEAE leading to study discontinuation in the maintenance phase were 4.9% in the active cohort versus 4.7% receiving placebo
- The majority of TEAEs were observed during up-titration of which (light) dizziness (10.2% for active drug versus 2.3% placebo) leading to study discontinuation while typical adverse effects seen in marketed CNS drugs were not observed