Anavex 2-73: Making Sense Of The Data
Jul. 28, 2016 3:02 PM
Anavex 2-73 appears to have stopped the progression of Alzheimer's disease for 31 weeks.
The Anavex 2-73 data requires careful analysis.
A Phase 3 clinical trial is needed.
In a day in which the Anavex (NASDAQ:AVXL) team announced positive news regarding Anavex 2-73, the company's stock dropped 40 percent. How did that happen?
Some investors may have believed this drug was a cure for Alzheimer's disease and were disappointed by the results. There has been a strong and vocal short "interest" in the stock, but neither accounts for the stock's sharp drop.
Perhaps the most important reason for the sell-off of the stock is that some of Anavex's most vociferous opponents scared investors by interpreting the poster presentation as proof for their narrative that the drug is a scam. The assertion made by Adam Feuerstein, among others, is that patients are slowly and inexorably declining while on the drug (article). But that is not what the poster graphs show (poster presentation). There was no decline in patients taking Anavex alone; indeed for the group taking Anavex alone, there was a slight increase in MMSE scores (mini-mental state examination) and no change in ADCS-ADL scores. Rather than having an additive effect, donepezil (Aricept) over time seemed to reduce the effectiveness of Anavex. As an aside, the same was also found in the recent LMTX tau clinical trial suggesting as heretical as it may sound that the sigma-1 agonist Aricept may through NMDA receptor activation actually have a negative effect on some Alzheimer's patients over time. The key to Anavex is not likely as a sigma 1-agonist but as an inhibitor of the pathway that leads to oxidative stress (by inhibiting neuronal nitric oxide synthase) (image one), (image two).
The only other substance that has stopped the progression of Alzheimer's disease at six months is Korean red ginseng. And while the action of Anavex 2-73 and Korean red ginseng are similar but perhaps not exactly the same - the long-term possibilities of Anavex 2-73 can potentially be presaged by the results of Korean red ginseng.
Anavex 2-73 average MSME score baseline: 22
Anavex 2-73 average MSME score 31 weeks: 25
Korean red ginseng average MSME score baseline: 22
Korean red ginseng average MSME score 24 weeks: 26.5
Korean red ginseng average MSME score two years: 24
(Korean red ginseng trial, see especially Figure two).
Funding for a phase three clinical trial is needed to see if Anavex 2-73 holds up with more participants, over a longer period of time, and with a placebo. But as I always argue, the lack of a placebo, a large sample size and an extended study period do not prove results but it does not negate them either.
I don't invest in stocks, partly for what happened here where some investors appeared to be swayed by a misreading of the data. But I would neither be too elated as a short nor too discouraged as a long over the actual results.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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