HPG1860 / Hepagene Therap - LARVOL DELTA

Discovery of HPG1860, a Structurally Novel Nonbile Acid FXR Agonist Currently in Clinical Development for the Treatment of Nonalcoholic Steatohepatitis. (PubMed, J Med Chem) - "Herein, we describe the design, optimization, and characterization of a series of N-methylene-piperazinyl derivatives as the nonbile acid FXR agonists. Particularly, compound 23 (HPG1860), a potent full FXR agonist, shows high selectivity, favorable ADME and pharmacokinetics profile, along with favorable in vivo activities demonstrated in both rodent PD model and HFD-CCl model and is currently in clinical development in patients with NASH in phase II."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Non-alcoholic Steatohepatitis

HPG1860 in patients with NASH: a phase II double-blind, placebo-controlled, dose-ranging study (EASL-ILC 2023) - P2a | "HPG1860 was safe and well tolerated. LFC significantly reduced with 3 mg and 8 mg cohorts over 12 weeks in patients with NASH. HPG1860 demonstrated a differentiated pruritus and LDL-C profile, providing favorable risk-benefit data to support further clinical development by assessing histological biopsy endpoints in patients with NASH."

Clinical • P2 data • Addiction (Opioid and Alcohol) • Dermatology • Fatigue • Hepatology • Non-alcoholic Steatohepatitis • Pain • Pruritus • Type 2 Diabetes Mellitus

HPG1860 in patients with NASH: a phase II double-blind, placebo-controlled, dose-ranging study (EASL-ILC 2023) - P2a | "HPG1860 was safe and well tolerated. LFC significantly reduced with 3 mg and 8 mg cohorts over 12 weeks in patients with NASH. HPG1860 demonstrated a differentiated pruritus and LDL-C profile, providing favorable risk-benefit data to support further clinical development by assessing histological biopsy endpoints in patients with NASH."

Clinical • P2 data • Addiction (Opioid and Alcohol) • Dermatology • Fatigue • Hepatology • Non-alcoholic Steatohepatitis • Pain • Pruritus • Type 2 Diabetes Mellitus

RISE: Phase 2a Study of HPG1860 in Subjects With NASH (clinicaltrials.gov) - P2a | N=89 | Active, not recruiting | Sponsor: Hepagene (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Non-alcoholic Steatohepatitis

Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Hepagene (Shanghai) Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2020 ➔ Aug 2021

Trial completion • Trial completion date • FGF19

RISE: Phase 2a Study of HPG1860 in Subjects With NASH (clinicaltrials.gov) - P2a | N=80 | Recruiting | Sponsor: Hepagene (Shanghai) Co., Ltd.

New P2a trial • Hepatology • Non-alcoholic Steatohepatitis

[VIRTUAL] SAFETY, TOLERABILITY , PHARMACOKINETICS AND PHARMACODYNAMICS OF HPG1860, A NOVEL NON-BILE ACID FXR AGONIST, IN HEALTHY VOLUNTEERS (AASLD 2021) - "HPG1860 was well tolerated, had a pharmacokinetic profile suitable for once-daily dosing and showed potent dose-dependent target engagement without altering plasma lipids in healthy volunteers ."

Clinical • PK/PD data • Dermatology • Hepatology • Non-alcoholic Steatohepatitis • Pruritus • FGF19

Hepagene Therapeutics, Inc. Announces Positive Results from Phase I Trial of HPG1860 (PRNewswire) - "'It is encouraging to see that there was no significant increase in LDL cholesterol despite excellent FXR target engagement with sustained C4 suppression,' said Rohit Loomba..."

P1 data