Anavex Life Sciences Corp (AVXL)

[12x]

Abeta 42 and Tau are FDA approve biomarkers.

Do you have a link to show they are approved as response/target engaged biomarker, not just approved as diagnostic biomarker?

Perhaps now the correct way to interpret the PR statement Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway is
Surrogate biomarker is AB42 since no amyloid PET
Newly available efficacy results are the reduction of amyloid plaques

Based on this 2022 publication https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9318582/

3.7. Pharmacodynamic/Response Biomarkers

Pharmacodynamic/response biomarkers change with exposure to a medical product or an environmental agent [4,5,6]. There are several applications of pharmacodynamic biomarkers, including the demonstration of target engagement in the early phases of drug development, the characterization of biological changes consistent with disease modification in later phases of drug development, use as a surrogate for clinical measures when fully validated, and—in special circumstances—as measures that are considered reasonably likely to predict clinical benefits to support the accelerated approval of an agent.

In AD trials, target engagement biomarkers demonstrate whether a pharmacologic agent has engaged the specific target of therapy. Pharmacodynamic biomarkers are also used as trial outcomes to determine whether an agent has a disease-modifying impact on AD. The lowering of amyloid plaque burden, as shown on amyloid PET, is regarded by the US FDA as a pharmacodynamic biomarker likely to predict a cognitive outcome. Plaque reduction was used in the accelerated approval of aducanumab [33]. Amyloid and tau biomarkers may function as either target engagement biomarkers, showing that the agent has directly or indirectly impacted Aß- or tau-related processes, or as biomarkers providing evidence in support of disease modification. Their interpretation depends on the COU defined for the biomarker prior to the initiation of the trial.