Anavex Life Sciences Corp (AVXL)

[Doc328]

mild Alzheimer’s disease (often called “stage 3” or early AD).

Actually Dr. Sabbagh (and the FDA guidance) considers stage 3 to be MCI and stage 4 to be mild AD. The 2b/3 was about 60% MCI (CDR 0.5) and 40% Mild AD. This is one reason why the "ADCS-ADL not needed with recent guidance" is a silly argument. As I've also stated, lecanemab and donanemab both showed P<0.01 for ADL scales secondary endpoints (ADCS-iADL and ADCS-MCI-ADL). Lecanemab patients were almost entirely MCI so were actually even earlier than Anavex 2b/3, while donanemab was about the same as in the blarcamesine trial.

Dr. Sabbagh's paper discussing stages. Specifically look at Figure 1. https://pmc.ncbi.nlm.nih.gov/articles/PMC12280795/

Lecanemab Phase 3 (figure 2) https://www.nejm.org/doi/10.1056/NEJMoa2212948?

Donanemab phase 3 (table 2) https://jamanetwork.com/journals/jama/fullarticle/2807533?