Anavex Life Sciences Corp (AVXL)

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Blarcamesine naysayings becoming difficult.

Not only is 2-73 scoring 100 percent in its trials, but it also seems to be scoring 100 percent on every new relevant study that appears.

All of this is both true and difficult to comprehend; at least for those whose perspectives on new candidate drugs are framed by legacy understandings of drugs acting in the central nervous system (CNS).

Simply, blarcamesine (Anavex 2-73) appears to be too good to be true; the “magic bean” phenomenon. Off hand, here’s my list of the three biggest things about the drug that, at least in some degree (usually great) are questioned, unaccepted, or simply rejected:

1. The drug is coming from a pharmaceutical startup, with but a handful of employees. No such company could possibly produce a safe, effective drug acting in the CNS.

2. There is no possible way a single molecule such as blarcamesine could produce such a multitude of positive therapeutic outcomes, acting in a diversity of biochemical pathways, cells, tissues, and organs.

3. Although every clinical test to date, whether in murines (lab rodents) or humans, has failed to produce any severe or disqualifying adverse events (side effects), the drug is inherently unsafe until far larger and more complete clinical tests confirm safety. The drug acts in the CNS, and virtually every drug acting there has severe, complicating, or obviating side effects. Blarcamesine can’t be any different.

The truth about these:

1. Yes, Anavex Life Sciences Corp is tiny. So what. Molecular chemistry is uncontrolled or unaffected by the size or age of the company owning or developing it. A criticism only of desperation.

2. Yes, it does seem improbable that a single molecule could produce so many positive therapeutic outcomes, in a diversity of diseases and conditions, in cells, tissues, and organs. But with the molecule’s unique mechanism of action (MOA), by its propitious activation of the sigma-1 receptor protein, the multitude of “downstream” processes can, indeed, be prompted. A few years ago Anavex was being criticized for promoting a drug with an unknown, even impossible MOA. “No way the drug could actually work.” Seen any of those criticisms in recent weeks? Of course not. The drug’s MOA is now more fully known and understood. Without any magic, whether derived from a bean or elsewhere, the drug really does produce a multitude of favorable therapeutic outcomes. Not so much of a mystery any more about how it can do this. The MOA is essentially confirmed.

3. But the drug may be unsafe; not enough clinical data yet to know for sure. Not so. Preclinical data from murines are entirely safe. And in the dozens of people taking blarcamesine in clinical trials not a single case of severe adverse events. Not a shred of data showing that it jeopardizes proper functioning of cellular genetics, of endocrine systems, or any other body function; indeed, unlike virtually all of the other drugs acting in the CNS.

The significance of all of this? Positive clinical results will continue to emerge. There is nothing that will prevent them from appearing. The drug works; is very safe. Simple as that. Believe it or not.