EDP-297 / Enanta Pharma - LARVOL DELTA

EDP-297: A Novel, Farnesoid X Receptor Agonist: Results of a Phase 1 Study in Healthy Subjects. (PubMed, Clin Transl Sci) - "Mean FGF-19 increased and C4 decreased up to 95% and 92%, respectively. EDP-297 was generally well tolerated up to 60 μg MAD, with linear PK suitable for once daily oral dosing, target engagement, and no food effect."

Journal • P1 data • Dermatology • Hepatology • Non-alcoholic Steatohepatitis • Pruritus • FGF19

EDP-297: a novel, highly potent, farnesoid X receptor agonist, results of a phase 1 study in healthy subjects (EASL-ILC 2022) - "Overall, EDP-297, a potent and selective FXR agonist,was safe and well tolerated with PK suitable for once daily oral dosing, a strong target engagement and no food effect."

Clinical • P1 data • Dermatology • Hepatology • Immunology • Inflammation • Liver Failure • Non-alcoholic Steatohepatitis • Pruritus • FGF19

EDP-297: A NOVEL, HIGHLY POTENT, FARNESOID X RECEPTOR AGONIST: RESULTS OF A PHASE 1 STUDY IN HEALTHY SUBJECTS (NASH-TAG 2022) - "Overall, EDP-297, a potent and selective FXR agonist, was safe and well tolerated with PK suitable for once daily oral dosing, a strong target engagement and no food effect."

Clinical • P1 data • Dermatology • Hepatology • Immunology • Inflammation • Liver Failure • Non-alcoholic Steatohepatitis • Pruritus • FGF19

A Study of EDP-297 in Healthy Subjects (clinicaltrials.gov) - P1; N=82; Completed; Sponsor: Enanta Pharmaceuticals; Recruiting ➔ Completed; Trial completion date: Feb 2021 ➔ Jun 2021; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis

A Study of EDP-297 in Healthy Subjects (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: Enanta Pharmaceuticals

Clinical • New P1 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis