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In retrospect, the only way this 31 week interim analysis had any chance of being viewed favorably by the investment world would have been if there was no cognitive decline seen at all or if there had been an actual improvement. But neither of those outcomes should have ever been expected. No one should have been expecting AVXL's drug to actually stop AD disease progression over the longer haul (in this case almost 7 months), much less reverse it.

At best AVXL's drug should have been expected to slow the rate of decline (more than say Aricept). Looking at the data plot (see below), there was only a small amount of cognitive decline after 31 weeks. But what would that decline have been without the benefit of the drug? Impossible to say because there was no placebo control group. So the drug may have indeed provided a benefit compared to placebo but there's no way to demonstrate that with this trial design.

The problem now is that the next data analysis (52 weeks) will have the same problem - signs of cognitive decline but impossible to say if the results are better than no drug or Aricept.

This trial was mainly to determine the MTD/Max Tolerated Dose




>>> Why Anavex Life Sciences Corp. Just Imploded

Disappointing Phase 2a study results from Anavex's lead compound sends its shares reeling.



Sean Williams

Jul 27, 2016


http://www.fool.com/investing/2016/07/27/why-anavex-life-sciences-corp-just-imploded.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2



What: Shares of Anavex Life Sciences (NASDAQ:AVXL), a clinical-stage biotech company focused on the development of drug candidates to treat Alzheimer's disease and other central nervous system disorders, plummeted by as much as 45% on Wednesday after releasing updated 31-week results from its phase 2a study involving lead compound Anavex 2-73, herein known as "2-73," at the Alzheimer's Association International Conference.

So what: According to the press release from Anavex, everything appears to be going according to plan. Per the press release,


Overall, efficacy results demonstrate what appears to be a converging and consistent response for all quantitative endpoints through 31 weeks, including cognitive and functional measures: Mini Mental State Examination (MMSE), Alzheimer's Disease Co-operative Study – Activities of Daily Living (ADCS-ADL), Cogstate and electroencephalographic activity and event-related potentials (EEG/ERP).

But further examination of the poster results now on Anavex's website reveals a potentially different story. MMSE scores, which had been a key selling point of 2-73 at the five-week mark, have shown some slight deterioration at the 31-week mark, as you can see below.





An argument can certainly be made that these scores are "sustained" around the baseline. However, investors who were potentially expecting an improvement, or reversal, in cognitive decline are clearly disappointed.

Additionally, the ADCS-ADL data also showed a quality-of-life score deterioration despite the poster suggesting a "maintenance" through week 31. At the midpoint of the week-31 analysis, the ADCS-ADL has hit a new low, which could imply the continuation of cognitive decline.






Don't get me wrong -- there were positives, too. The poster suggests a discernible improvement in the Hamilton Depression Rating Scale at the 31-week mark. But that's probably nowhere near enough to counteract the ambiguities of its MMSE and ADCS-ADL data.

Now what: Today's data is exactly what I warned about just two weeks ago. Although we'd witnessed promising data previously with 2-73 and a number of other earlier-stage compounds, the blood-brain barrier is tricky to tackle, and most Alzheimer's drugs fail in clinical trials.

Does today's poster release mean 2-73 is a failure? No. But it didn't exactly instill confidence that 2-73 is the drug of the future for Alzheimer's patients. There are a lot of questions to be answered by Anavex once we hit the 52-week mark, prime of which is whether we see a reversal of the MMSE and ADCS-ADL scores from the 31-week mark, where they appear to be trending lower and implying disease progression.

For now, my suggestion would be to observe Anavex safely from the sideline. There's little reason to risk your hard-earned money on a drug developer whose pipeline is still very wet behind the ears.

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