Anavex (AVXL) is a bio-pharmaceutical company that amazingly few know about, but those who do are passionate about, asserts Tom Bishop, an industry-leading small cap stock expert and editor of BI Research.
Its lead drug is Anavex 2-73 (A2-73), an orally available drug with a clean safety profile that gives every indication so far of being highly effective against Alzheimer’s disease.
I’ll explain. Though there are 4 drugs approved, none of them really works beyond 6 months. It is currently in a 1-year, 450-patient Phase 2b/3 Alzheimer’s trial that is halfway through enrollment. If successful, the company will file for provisional approval.
In Anavex’s Phase 2a trial the high dosage of A2-73 cohort saw only a 3-point decline in ADL score (a normal score is about 70 or better) as compared to a 25 point decline (8 times the decline) in the low dosage group (that basically did not work so was effectively a placebo) at 148 weeks.
Same story with the Mini Mental State Exam (MMSE) score (perfect is 30, in this realm scores run below 26) where those taking the higher dose of Anavex 2-73 saw a drop of 1.1 in the MMSE score over two years vs. a drop of 4.4 in untreated patients.
This is phenomenal. Nothing on the market today can come even close to this and if the company can prove this in the Australian trial it will be on track to become the lead Alzheimer’s drug in a market that is at least $10 billion worldwide.
Proof of the pudding, 94% of those who have completed the current 1-year trial period are voluntarily continuing to take A2-73, and some (from the earlier Phase 2a trial) have continued for as much as 3 to 4 more years now. Sometimes that speaks louder than the hard data.
In addition, Anavex is currently wrapping up a Phase 2, 120-patient study with A2-73 for Parkinson’s dementia and is working on three Phase 2 trials for Rett Syndrome, a devastating disease that strikes girls in infancy handicapping them severely in almost every function.
Data from these trials are expected in 2020. I could go on for pages. There are no guarantees on Wall Street, but I hope you will agree that the above at least stacks the odds in our favor.
