All Three Core Histology Endpoints Statistically Significant
The company said it secured statistically significant results versus placebo across every histological endpoint, including the two core registration endpoints of fibrosis improvement without MASH worsening and MASH resolution without fibrosis worsening, as well as the composite measure.
MASH resolution without fibrosis worsening reached 62.5% versus 5.3% on placebo, a 57.2 percentage point gap; fibrosis improvement without steatohepatitis worsening was 50.0% versus 15.8%; and the share achieving both was 37.5% versus 5.3%.
Using the artificial intelligence tool qFibrosis alongside pathologist reading, the fibrosis improvement rate was 72.7% against 12.5% on placebo, with statistical significance also confirmed under pathologist-only and combined artificial intelligence-pathologist reading.
Kiwoom Securities assessed that confidence in the trial results increased further as a consistent fibrosis improvement effect was confirmed across three mutually independent analytical methods.