Characterizing circulating pharmacodynamic biomarkers of IFNβ-1a biologics [low]

This is an extension of the data submitted in GSE207945 which profiled longitudinal plasma samples from healthy subjects treated with single therapeutic doses/high doses of IFNβ-1a (30 μg) or Pegylated IFNβ-1a (125 μg) or placebo, to identify candidate PD biomarkers for the two biologics (n=248 for IFNβ-1a and N=528 for pegIFNβ-1a).

The current project is a continuation study profiling longitudinal plasma samples from healthy subjects treated with a low dose of IFNβ-1a (7.5 μg) and pegIFNβ-1a (31.25 μg). In the current study, we reproduced the previous PD biomarker candidate responses at an intermediate/lower dose IFNβ-1a (15 μg) and pegIFNβ-1a (62.5 μg), and further characterized their PD response using characteristics such as significant area under the effect curve, dose-response, temporal profile and return to baseline, variability and sensitivity of the biomarker with sensitive doses on the steep portion of the dose-response curve and mechanism of action using the three tested dose-groups (high, intermediate and low) in the study.