EDP-305 Treatment of Primary Biliary Primary Biliary Ductitis: Significant Improvement in Alkaline Phophatase (ALP) Levels

Enanta, a clinical-stage biotechnology company dedicated to the development of small molecule drugs for liver disease, today announced the main results of the INTREPID study of the French X-receptor EDP-305 (FXR)The INTREPID study was a 12-week, randomized, double-blind, placebo-controlled Phase II study that evaluated the safety, tolerance, pharmacokinetics, and efficacy of EDP-305 for the treatment of primary biliary choline (PBC)The main endpoint of the study was to assess the proportion of subjects (ALP responses) that at the 12th week reduced the pre-treatment value by at least 20%in the intentional therapy (ITT) analysis, the EDP-305 1 mg and 2.5 mg treatment groups produced an ALP response of 45% (n - 14/31, p - 0.106) and 46% (n - 13/28, p - 0.063) compared to 11% of the placebo groupCompared to the placebo group, the absolute changes in ALP in the EDP-305 1 mg group (p - 0.017) and 2.5 mg group (p - 0.021) were statistically significant at 12 weeksin ITT analysis, the key secondary endpoints (including alanine amino metastase, tenonine amino metase, and gamma-glutamate transferase relative to baseline) also had statistically significant differences from placebos