Biotechnology company Enanta Pharmaceuticals has reported positive results from its ARGON-1 Phase 2a study of its lead product candidate EDP-305 to treat non-alcoholic steatohepatitis (NASH).
EDP-305 is a potent Farnesoid X Receptor (FXR) agonist under development to treat NASH and Primary Biliary Cholangitis (PBC).
People suffering from NASH could develop fibrosis, which is the first stage of liver scarring, and that can eventually lead to liver cirrhosis.
During the 12-week, randomised, double-blind, placebo-controlled ARGON-1 Phase 2a study, Enanta EDP-305 was assessed for safety, tolerability, pharmacokinetics and efficacy in NASH.
The subjects were administered 2.5mg dose, 1mg dose of EDP-305 and placebo. More than 400 people participated in all studies so far.
Primary endpoint was alanine aminotransferase (ALT) reduction at week 12, which was met in the 2.5mg dosing group.
The secondary endpoint was met in the 2.5mg dosing group, with a reduction in liver fat content as measured by MRI-PDFF at week 12.
Enanta Pharmaceuticals president and chief executive officer Jay Luly said: “Today’s statistically significant results demonstrate that EDP-305 is a potent FXR agonist that reduces ALT and has exhibited strong target engagement in NASH subjects.
“Additionally, EDP-305 is differentiated from other FXR agonists in development today by its significant reduction in liver fat at 12 weeks. Our goal now is to initiate a 72-week Phase 2b study named ARGON-2 with histological endpoints in NASH patients, which we plan to initiate in the first half of calendar 2020.”
In addition, the company said that has achieved sufficient enrolment its Phase 2 INTREPID study of EDP-305 in subjects with PBC.