Anavex Life Sciences Corp (AVXL)

[RedShoulder]

Why did Anavex include a 30mg arm?

Looking at the (admittedly very small sample size) data from Phase 2, I am surprised they went with that extra arm (unless to show it would do worse than 50mg and get some dosage-dependency brownie points?).

Also, considering it was small for a Phase 3 trial for AD, why didn't they exclude patients who lacked the wild-type SIGMAR1 gene?

These are meant as real questions, not rhetorical ones.

Joseph, you are laying out two legitimate questions.

There is no doubt that the results would have been much better had they gone with just the 50mg dosage and with only the wild type SIGMAR1 gene based on what they learned from the successful Ph-2 results. With that said, consider that they still had a very successful Ph-2b/3 AD trial which "met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline." and that included the low dose 30mg, and the non-wild type SIGMAR1 gene.

I think Anavex was wanting to show dose dependency by including the low dose 30mg in the trial; and possibility they wanted to see the degree of improvement of the non wild type, as Missling did say the drug did help that cohort some.

I suppose one could argue that Missling's philosophy from the Ph-2 trial that he said was set up to fail if the drug did not work, carried over into the Ph-2b/3.

I'm concluding that the fact that he did include the low dose 30mg cohort, and the non wild type gene cohort, yet still had a very successful AD trial which "met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline." clearly indicates a very strong showing of the total trial results.

The 50mg data alone will show a drug that can stop or reverse the disease; and no other drug has ever done that in an Alzheimer trial.

A clear win, ... bring on the full data.


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