Anavex Life Sciences Corp (AVXL)

[georgejjl]

Conclusions
• Small, data rich, AI-driven adaptive single arm precision medicine clinical
studies as designed to assess ANAVEX®2-73 efficacy may be a template
for future studies investigating CNS drugs in order to rapidly explore novel
mechanism of action, before engaging in larger trials
• Propensity matched real world evidence experiment using ADNI
shows efficacy of patients with high ANAVEX®2-73 concentration vs
synthetic control arm at week 104 (p<0.01)
• Limitations:
• Comparative ADNI data available only up to 104 weeks
• Number of genetically characterized patients in comparative ADNI data
• MMSE cognition score to match patients
• Hence: Randomized placebo-controlled ANAVEX®2-73 Phase 2b/3
study currently underway with 450 early Alzheimer’s disease patients
• Additionally: Gut microbiota species identified as linked to ANAVEX®2-73
response consistent with the interaction of SIGMAR1 and the gut-brain
axis and inflammatory mechanisms

https://www.anavex.com/wp-content/uploads/2019/12/CTAD-ANAVEX2-73-ADNI-Presentation-2019.pdf

Good luck and GOD bless,