Anavex Life Sciences Corp (AVXL)

[nidan7500]

Flash:

Became:

“FDA has allowed Anavex to proceed with the Phase 2 study protocol, ANAVEX2-73-RS-001, A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients with Rett Syndrome using experimental drug ANAVEX®2-73 for the treatment of patients with Rett syndrome. The Phase 2 study is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX®2-73 formulation to treat Rett syndrome. !Pharmacokinetic and dose finding will be investigated in a total of 15 patients over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers. All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study will be followed by a planned placebo-controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3 month treatment period.

https://www.anavex.com/anavex-life-sciences-announces-fda-approval-of-ind-for-phase-2-trial-of-anavex2-73-in-patients-with-rett-syndrome/


To me it seems like a convoluted way of saying the FDA has required Anavex to do a smaller (probably open label) dose titration study before they will allow them to do the Rett trial they had asked for in the original IND they filed.

It’s not clearly spelled out if this is actually a phase 1 or phase 2 trial but the way the PR is written, it certainly leaves the matter open to debate imo.

Flash, thanks for this. I am still stuck back at the Friday announcement (on option day) wondering why AVXL chose to do PR of this magnitude on Friday the week before multiple other CNS big events get covered.

I did predict here there would be a PR before the conference but never expected anything on Friday (w/low confidence of any Monday PR also)...but, this gets tricky...what if an unexpected compression of events (positive) has developed and DR.M and crew decided to go w/Friday's PR b/c there is a lot already planned for next week? I would add to that the possibility that initial trial does have already been administered and RS kids have responded well. Take it from there....

The PR Friday was a surprise (I expected to hear from BIIB re some kind of collaboration). If BIIB objected to any RS PR stepping on their show then they may have influenced the Friday release, it's complicated. I do still see some good news soon w/events escalating quickly. AND, it's about time.