Anavex Life Sciences Corp (AVXL)

[Investor2014]

Well Anavex have removed the CTAD and revised CTAD presentions. The JPM presentation is what we are left with.

Here is the Full Findings of Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) at Clinical Trials on Alzheimer's Disease (CTAD) 2022.

This as one can see, is a very thorough presentation with all the detail to support meeting the endpoints as they were always defined. There is no mention of Odds Ratios that I can find in that presentation.

The only comparison that Anavex is making to lecanemab in the JPM presentation is regarding CDR-SB. The Anavex CDR-SB chart goes the wrong direction in separating the combined treatment arm from placebo up to 24 weeks, whereas the lecanamab corresponding chart shows clear separation between placebo and treatment right from the outset continuously improving.

The non linearity of the A2-73 response, dose and concentration relationships is an issue and one that Anavex have tackled using KEM Formal Concept Analysis to show both one and two directional correlations. They will have to do the same subgroup analysis on the P2b/3 data, which is why we are waiting on full results. This is also why imo a P3 PM trial using patient selection biomarkers of response to A2-73 will be necessary and likely successful.

Anavex result are on a non Gaussian distribution, certainly with the relatively small trial populations we have seen so far. Hence the difficulty in showing clear classic outcome measures.

Nobody with any experience in biotech and statistics is buying the Anavex CDR-SB comparison to lecanamab.