Replies to post #256652 on Anavex Life Sciences Corp (AVXL)

[Doc328]

On post-hoc analysis, CDR-COA was found to be one of the more sensitive measures in the large successful rivastigmine (Exelon-Novartis) Parkinson Dementia phase 3 study that led the FDA to award the additional indication for the drug to treat PDD. This was back in 2006 and it was approved for AD in US 2000. ADAS-Cog was the primary endpoint in the phase 3 study. This likely led to Lilly choosing CDR-COA as the primary endpoint, with ADAS-Cog and other measures as the secondary endpoints. Anavex just followed suit.

I posted about this endpoint in more detail so that everyone can put the A273 results in context upon release.

[Doc328]

How much of a response to the Continuity of Attention would have to be achieved for Missling to consider going for PA?

This is a small study with only 40 patients in each group. There won't be any PA based on the low powered phase 2. The goal is to figure out which dose to bring forward into phase 3 and whether genetic markers (i.e. S1R and COMT WT over variant) should be used as an eligibility criteria in the next study.

From page 24 of the June presentation - why do they try to correlate the Continuity of Attention response(in PDD) to the Cogstate IDN response in AD? Is that just to cross reference results?

I think its just to say there was some indication that AD patients (with mild dementia) had improved reaction time/attention in the small 2a study with A273, so we are optimistic that PDD patients do the same in a similar test. The CogState is a computerized cognitive measure with multiple subtests. The Identification (IDN) task is a choice reaction time paradigm that measures visual attention with some parallels to the CDR-COA being used as the primary endpoint in PDD