Some notes from the B. Riley Conference-
Episodic Memory CDR syst. previously compared to ADAS COG Score published correlated to 70% from PDD to Alz.
Placebo dose declined.
30mg stopped decline.
50mg dose improved cognition.
Net increase of cognition in dementia in Study.
Also improvements in;
-Choice reaction time
-Digital Vigilance
-Improvement in REM Sleep Behavior which is known to suffer in Parkinson’s disease in general.
-Global Aging being addressed by A2-73.
-Macro Intervention; Let the body decide how to restore function. That’s exactly what we’re doing with Sigma One Activation, which is an endogenous system to restore functionality. We’re just helping the body to help itself.
Strong Team- Former FDA Officer Walter Kaufmann, Chief Medical Officer for Anavex and key leader for Rett Syndrome and Fragile X
Questions;
1. How does Sigma 1 Receptor stimulate improvements in a cell that’s already deteriorating?
Answer; The cells are dynamic so they are not stuck in one pattern. They can regenerate and form new cells but it’s a dynamic, basically it’s like a balance. And the fact that once you get intervention you can bring the balance to restoring this cellular dysfunction.
The other explanation is that Sigma One has been shown to remove toxic proteins which have been aggregated or accumulated out of this space of cellular stress. So these are two mechanisms which are helping to explain how the drug works and able to restore function as we’ve seen now in the clinic.
Question 2:
How do the next six to twelve months look?
Answer;
3 years of cash, 75m with no debt. We will have an update on the quarter very soon.
Milestones;
More complete data of Parkinson’s Disease Dementia Study,
More complete data of first U.S. Rett study
Top Line date of Avatar Study, the second Rett study
Top line data of third Rett Study, Excellence, the Children’s Study
Top line data at middle of the year for second compound Anavex3-71 with data from FTD, has Orphan Designation.
- We are now in parallel discussion with the Agency the path forward for PDD with this data at hand, as well as Fragile X preclinical data to design a pivotal study in Fragile X.
The same applies to Alzheimer’s Disease and Rett Syndrome… to accelerate time to Market for these indications.
