Hi all,This is how I understand the MEND Study.The two goals are...

Hi all,

This is how I understand the MEND Study.

The two goals are thus.
1. Investigate how the study medications enters and leaves the blood over time.
2. To ascertain if MPL slows progress of MND/ALS.

So in the first 28 days and UP to 28 days there is an administration of a single dose ( includes blood specimens, thyroid function haematology) . Then daily dose for 28 days. After 28 days the patient is offered dose escalation for 10 to 12 months. The dosage is tailored to body weight up to 7 tablets per day.

Now onto the Biomarkers. The laboratorities are looking at (Neurofilament Light Chain Biomarkers. There are two in this category. They are promising markers to support diagnosis and predicted outcome). They are measured by enzyme linked immunoassay and intra assay tests.

Secondly they are looking at (P75 ecd)
urine biomarker , this is a robust marker than if it predicts a high level one has high level of MND. If the marker is low in level the level of MND is lower and the drug may be influencing the outcome.

These two markers I believe, will be the cornerstone of the drug in relation to Orphan Drug Designation here in Australia TGA and the FDA.

Chat soon

Kpax