Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex Life Sciences Corp. (AVXL) Q1 FY2026 earnings call transcript

Jesse Silveira
Analyst
0:24:21

Okay, thank you. If I have it correct, you have committed to running a confirmatory phase for a trial if approved for CMA using paying patients as a real-world cohort. Isn't that correct?

Christopher Missling
President and CEO
0:24:36

Sorry, what patients?


Jesse Silveira
Analyst
0:24:38

like paying patients in the E.U. Assuming you are actually approved under CMA, will you be running a phase IV trial with these patients?

Christopher Missling
President and CEO
0:24:46

We will run.

Jesse Silveira
Analyst
0:24:47

Or how would that look, I guess?

Christopher Missling
President and CEO
0:24:48

Yeah, we would run a trial as the regulatory body, the CHMP guidelines, provides for that you get approved, and then in parallel, you will run a confirmatory study. Yes.

This would be the AD-005 trial, which IMO would have to be a P3, not an FDA style P4 trial!

So it's a very intriguing project to be part of, and the ACCESS-AD program consists of multiple features. Among them is also a review of healthy diet, also a supplement diet is part of that, and they're all separate, they're not together, and as I just mentioned, one part is explicitly a trial of blarcamesine in a placebo-controlled clinical trial.

Jesse Silveira
Analyst
0:28:01

Sorry if you mentioned, is this in early Alzheimer's patients or is there like a preventative component to this trial?

Christopher Missling
President and CEO
0:28:10

Yeah, so it's a good question. It could end up being a preventative also, but right now it's consistent with an early Alzheimer's population as a target population.

Jesse Silveira
Analyst
0:28:21

Okay, and this would be considered AD006 on your pipeline chart, is that correct?

Christopher Missling
President and CEO
0:28:27

That's correct, yes. That would be AD006.

5 result(s) found for: anavex. Displaying page 1 of 1.
There was ever only one OLE trial labelled ANAVEX2-73-AD-EP-004, which followed the P2b/3 ANAVEX2-73-AD-004