Anavex Life Sciences Corp (AVXL)

[frrol]

A placebo control's purpose is to isolate and elucidate the effect of the drug treatment itself vs the very real psychological effect of believing you are being treated.

As for biomarkers, a completely different study tool, there are two kinds: efficacy and predictive.

Efficacy biomarkers act as surrogates for or supplements to more obvious but perhaps elusive or difficult to determine efficacy endpoints. A relevant example for us is glutamate levels. We have cited it as a kind of efficacy biomarker for RS trial participants in the intensive PK/PD phase.

The predictive biomarker's purpose is to isolate and elucidate physiological predispositions to treatment benefit. I.e., they can help you figure out who will benefit from the drug treatment. You are referring to these, the predictive biomarkers. We are using wild type SIGMAR1 for that purpose. Missling's quote can be a bit misleading without context: we are using it not to select participants but to select how we stratify the results into analysis cohorts.

And as you can see, our predictive biomarkers have nothing to do with our placebo control nor the placebo effect. If a patient has been told he has a "positive predictive biomarker" (whether the biomarker is predictive or not), his potential for placebo effect may be greater, if that is what you're asking. And the analysis would likely show that. But with the placebo control in place, the effect would get nullified in the analysis and the drug's actual effect still gets elucidated. Good placebo controls do wonders for making drug trials reliable.

I hope that helped.