ENTA—any reason why they are looking at NAFLD and not NASH in the [ohase-1b portion of the trial]? Does the FDA want some safety data in NAFLD before looking at more advanced diseased pts?
Nothing to do with safety concerns.
The patients in the phase-1b portion of the trial are not getting biopsies, so ENTA will not know for sure if they have NAFLD/NASH; however, they are presumed to have NAFLD based on entry criteria wrt obesity and/or type-2 diabetes. (Note that ENTA refers to these subjects as presumtive NAFLD patients.)
The point is to see if EDP-305's PK/PD are different in (presumptive) NAFLD patients as compared to healthy volunteers.