Anavex Life Sciences Corp (AVXL)

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Indications of the Anavex Future

As a biologist, I’ve scrutinized any number of otherwise obscure research reports dealing with Anavex sigma-1 receptor agonists. The most revealing and indicative are the many reports of the Anavex molecules acting in murines, lab rats or mice, against a range of diseases and conditions.

Those reports, coupled with Anavex researchers laying out various molecular and cytological mechanisms of action of their sigma-1 receptor agonists, prompted me several years ago to take a position in AVXL equities. I didn’t bet my ranch; used only discretionary funds whose loss would not impact my financial status in any way. As with all continuing to maintain a strong AVXL position, I’ll either lose my investment, or, in time (a few years, at least) it will be handsomely rewarding. Here is my analysis and perspective of the most recent Anavex information, at this URL:
https://www.anavex.com/wp-content/uploads/2018/07/Anavex-AAIC-2018-DT-01-Presentation.pdf

More so than ever before, I’m convinced my investment in Anavex Life Sciences Corp was a good one. Here are my thoughts on the matter.

Could an Anavex molecule actually stop or reverse the universal progression of Alzheimer’s dementia? This was indicated by a number of murine studies. The unique abilities of the Anavex drugs (orally administered) to ably cross the blood/brain barrier and become incorporated inside neurons (nerve cells), and thereafter restore previously lost nerve functions was both demonstrated in murines, and the mechanisms of these actions were graphically described.

But all of that was only in animals. In humans? Yes, there, too; but only in a small population of Australians, in a clinical trial whose goal was merely safety and tolerability, not efficacy. Wonderful results for a significant portion of those trial participants. Safe (no disqualifying side effects), and tolerable (dosages effectively determined).

The larger question, now, is what fraction of a large, generalized Alzheimer’s population might favorably respond to Anavex 2-73 treatment. That small Phase 1 clinical trial was insufficient for this determination.

Now, plans are underway for a full-scale double-blind, well-controlled clinical trial of Anavex 2-73 against Alzheimer’s disease. I’m eager to learn how that trial turns out. But with the new information just released, it's almost certain that clinical trial will yield data allowing (well, forcing) FDA approval.

Now, Anavex has discovered genomic factors that predispose Alzheimer’s patients to favorable treatment by Anavex 2-73. Those with the disease and the favorable genes will have their Alzheimer’s symptom prevented from progressing, or have them suppressed. Either outcome exceeds any existing standard of care.

The genomic factors were anticipated; now known, and they will be used to select participants in the up-coming Phase 3 clinical trial. In effect, Anavex now gets to include only those who will favorably respond to treatment; having the pre-tested genes for such.

Wonderfully, the recent Anavex announcement indicates that about 80% of Alzheimer’s patients have Anavex-favorable genes. Until this was announced, the number of Alzheimer’s patients that could be treated was unknown. Now, it’s known — four out of five. Moreover, genetic testing can pre-select patients, so the 20% that are not open to Anavex treatment will not be unsuccessfully subjected to it.

To gain FDA approval for a new drug, it must be a) safe (few side effects), b) be efficacious, yield positive treatment outcomes, and c) equal or eclipse existing standard of care drugs.

The new information raises no safety issues. As in both murines and humans, the Anavex molecules are safe.

The big Phase 3 clinical trial will reveal significant, positive treatment outcomes for the vast majority, or universal fractions of trail participants. Anavex has everything stacked in it’s favor: include in the trial only those with treatment-favorable genes. Significant positive clinical outcomes are now assured.

Lastly, any of those treatment outcomes will eclipse the treatment outcomes of any existing Alzheimer’s drug. The standard of care is presently minimal; merely slowing for a moderate period the rate of symptomatic decline. Every shred of evidence, both murine and human, indicates Anavex 2-73 will either stop the progression of Alzheimer’s symptoms, or even reverse them. With either of those outcomes, FDA approval is mandated.

In summary, the biggest news is the determination that 80% of Alzheimer’s patients have Anavex-favorable genes. Clinical matters will progress more slowly than wished, but I have a five-year perspective on my AVXL investment. Today, I’m confident that in five years my Anavex holdings will be quite valuable, and more importantly, Alzheimer’s disease will, for at least 80% be wonderfully treatable.