Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex would not announce plans to initiate a confirmatory AD trial if the P2b/3 trial was pivotal.

Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.

Here parallel refers to the preliminary surrogate biomarkers and considering initiating discussions with regulatory agencies for Accelerated Approval. Ergo the P2b/3 trial was not a pivotal registrational P3 trial.

With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine),” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.

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