Anavex Life Sciences Corp (AVXL)

[F1ash]

”The 12-week trial — which will cost about $1 million total and enroll between 50 and 80 patients — will measure the drug’s effect on seizure reduction, cognitive impairment, mood disorder, autistic behavior and anxiety, Christopher Missling, president and chief executive officer of Anavex, told MarketWatch.”

https://www.marketwatch.com/story/anavex-awarded-grant-to-fund-clinical-trial-of-rett-syndrome-drug-2017-01-19


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.