Enanta's Phase 2a Study Of EDP-305 In NASH Hits Goals

(RTTNews) - Enanta Pharmaceuticals, Inc. (ENTA) on Wednesday said its Phase 2a study of EDP-305 for the treatment of non-alcoholic steatohepatitis (NASH), dubbed ARGON-1, achieved its primary and secondary endpoints.

NASH is an advanced form of non-alcoholc fatty liver disease.

The primary objective of the study was to analyze the change in the liver enzyme alanine aminotransferase (ALT) levels in the blood. The ALT levels are elevated in patients with NASH.

At Week 12, there was a statistically significant ALT reduction of 28 U/L in the EDP-305 2.5mg arm compared to 15 U/L in the placebo arm.

The secondary objective of the study was to find the change in liver fat content measured by magnetic resonance imaging-estimated proton density fat fraction or MRI-PDFF, a novel, bio-marker based imaging.

A significant reduction in liver fat content was also observed. Other secondary objectives such as reduction in C4 proteins in the blood and lower Gamma-glutamyl transferase (GGT), an enzyme that is found in high concentrations in the liver, and increases in Fibroblast growth factor 19 (FGF-19) and Alkaline phosphatase (ALP) were observed.

ENTA closed Wednesday's trading at $71.28, down 0.75%.