Anavex Life Sciences Corp (AVXL)

[Investor2014]

Summing up PDD OLE trial dates and stuff.

Initiation Date 17th January 2020, which as of writing was yesterday!
IMO it is highly unlikely that a record updated 16th Jan 2020 would deliberately forward-date trial initiation to 17th Jan 2020 if that trial in reality was initiated several months ago.

Add to that the Spanish REEC Authorisation date of 26/11/2019, only about a months and half ago, which has not been changed with this update.

Also note that the EMA record has a "Start Date*: 2019-12-05". This date is defined as:


Furthermore, this MB has for quite some time been expecting PR announcement of the PDD trial extension, as I recall based on Missling mentioning one way back in a quarterly CC. However, it was only officially PR'ed 16th December 2019 as part of the annual Fiscal Results:

Enrollment for the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study[4] is expected to be completed by the end of December 2019 with top-line data expected mid-2020. To offer all participants of the study access to ANAVEX®2-73 (blarcamesine), a voluntary 48-week open-label extension, including microbiome assessment, was initiated and currently 100% of eligible participants have opted into the extension study.

Or did I miss an old PR from about a year ago?

Was initiated, is a bit lax but it must mean that the CROs and patients was made aware some time before 16th Dec 2019 giving time for 100% of eligible participants to express their opt in decision.


All this just being tardy record keeping would imo required some very convincing arguments.

A) Based on all this available data, I can only concluded that the PDD OLE extension was initiated yesterday 17th January 2020!

The implication of (A) is that there will be a gap of up to almost 1 year for some patients between the end of their P2 PDD trial dosing (with any of placebo, low or high dose A2-73).

If (A) is really the case, it seems an odd situation and IMO hardly one originally created by design as Doc328 elaborated, although a bunch of very long to shorter washout periods could also be instructive.

Someone suggested the gap might have been filled by Compassionate Use of A2-73, but I very much doubt that as it would make the baseline for OLE patients quite a mess to establish. Aside from that how does the CRO and sites keep active hold of patients that finished a trial up to a year ago and then rally them all to opt in to the OLE just sometime before Dec 16th 2019?

So does the initiation of the PDD OLE signal the completion of the entire PDD P2 study? The answer to that is maybe, definitely maybe! I think if so and likely, it is simply a coincidence because usually the transition from a trial to its OLE is seamless for each patient. Waiting for all patients completing the original study creates these staggered washout periods that seems highly undesirable.

Oh well, some more open Anavex questions here hard to compute.

Lewy Body Dementia and the change of N from 120 to 150

First of all the Spanish REEC site does not mention Lewy Body Dementia at all, but it appears in the EMA record. It this a dropdown list box entry error or?

As Doc328 mentioned PDD and Lewy Body Dementia have similarities and can be hard to diagnose, at least early on. It may be that some of the enrolled patients have later been identified as having Lewy Body Dementia. This may have prompted the N increase of 30 patients as an estimate to achieve at least 120 patients with confirmed PDD.

This situation may then have presented an opportunity for the PDD OLE study to verify if A2-73 might also be effective for Lewy Body Dementia.

So either the Lewy Body thing is an EMA typo and the + 30 N represents the Australian Expansion, or Anavex got an opportunity to test A2-73 on a few Lewy Body Dementia patients in an open label setting.

PDD OLE and Titration to 50mg
Thanks to F1ash for catching that one in the REEC register.

Well that is another gap to bridge, I mean from 10mg or 20mg to 50mg is hefty titration jump. This again raises the question why such low doses to start with given that the P2a AD trial has already establish that >4ng/mL blood contraction of A2-73 is the therapeutic window and that high concentration is correlated with high dose? Guess there is a tolerability issue to deal with - not sure what else one could conclude?

PDD trial management and as for getting old in Spain
Spain has one of the highest rated health care systems in the world, despite it being a single payer tax funded one. I for one would much prefer retiring to Spain that the USA not just for healthcare reasons, but that discussion doesn't belong here.

What more is there to say or speculate on only The Flying Spaghetti Monster knows,