A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)
Latest Information Update: 21 Sep 2022
At a glance
- Drugs EDP 305 (Primary)
- Indications Primary biliary cirrhosis
- Focus Therapeutic Use
- Acronyms INTREPID
- Sponsors Enanta Pharmaceuticals
- 05 Jun 2020 Status changed from active, no longer recruiting to completed.
- 06 May 2020 Primary endpoint has not been met. (Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12)
- 06 May 2020 According to an Enanta Pharmaceuticals media release, Clinical Professor, Elson S. Floyd College of Medicine, Washington State University, the Principal Investigator for the study