SHANGHAI, May 25, 2023 /PRNewswire/ — Hepagene Therapeutics, Inc., a clinical stage biopharmaceutical company focusing on developing novel therapies for patients with chronic liver diseases, today announced that Hepagene will present two posters highlighting the preclinical and clinical development for its two non-alcoholic steatohepatitis (NASH) programs at the European Association for the Study of the Liver (EASL) Congress, taking place in Vienna Austria, June 21-24, 2023. Details of the presentation are as follows:
Highly Selective THR-β Agonist HPG7233
Title: Preclinical characterization of HPG7233, a potent, liver-target and highly selective thyroid hormone receptor beta agonist for nonalcoholic steatohepatitis Presentation Number: 391 Session Title: NAFLD: Experimental and pathophysiology Presenting Author: Dr. Que Liu (Chief Medical Officer)
HPG7233 is a novel liver-targeted and highly selective small molecule thyroid hormone receptor beta (THR-beta) agonist aimed at serum and liver lipid metabolism.
HPG7233 demonstrated high selectivity and potency, great liver-enrichment and liver/plasma exposure profile in rodent and non-rodent animals, significant reduction of liver index and serological markers level, and significant reduction of NAS score in NASH model. These results provide strong evidence to support continuing efforts in HPG7233 development for NASH and dyslipidemia indications.
Next Generation Non-Bile Acid FXR Agonist HPG1860
Title: HPG1860 in patients with NASH: a phase II double-blind, placebo-controlled, dose-ranging study Presentation Number: 383 Session: NAFLD: Therapy Presenting Author: Dr. Naim Alkhouri (Principal Investigator)
This phase 2 study (NCT05338034) is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial (RISE trial) to evaluate the safety, tolerability, efficacy, and pharmacokinetics of orally administered HPG1860 tablet at doses of 3 mg, 5 mg and 8 mg in 87 adult patients with presumed non-cirrhotic non-alcoholic steatohepatitis (NASH). The primary objective of the clinical trial was to evaluate the safety and tolerability of HPG1860. Secondary endpoints included percent change from baseline in liver fat content (LFC) measured by MRI proton density fat fraction (MRI-PDFF), plasma pharmacokinetics of HPG1860, pharmacodynamic parameters, and serum NASH biomarkers.
In the RISE trial, once daily administration of HPG1860 for 12 weeks was generally well tolerated and most AEs were mild and moderate. Treatment-related pruritus occurred in 9.1%, 9.5%, 27.3% of patients in the 3, 5, and 8mg cohort respectively and no significant change in LDL cholesterol (LDL-C) was observed in the 3 mg, 5 mg and 8 mg HPG1860 cohorts. Meanwhile, significant reductions of mean relative changes in LFC at week 12 were observed in 3 mg and 8 mg HPG1860 cohorts. Treatment of HPG1860 also reduced liver enzymes including ALT and GGT.
“We are excited about the great progress of HPG7233, a novel once daily THR beta agonist, which may have robust efficacy with benign safety profile in clinics. The compound is on track for a Phase 1 study in the second half this year.” said Dr. Que Liu, CMO of Hepagene. “HPG1860 is a new generation of non-bile acid FXR agonist which is different from first generation bile acid type obeticholic acid (OCA). HPG1860 has shown liver enrichment profile in preclinical studies and displayed robust efficacy with much better safety profile vs OCA in clinical settings. We believe that HPG1860 in combination with HPG7233, a novel THR-beta agonist, will significantly improve efficacy while maintaining benign safety profile”.
In summary, given its significant improvement in LFC and a benign safety profile in NASH patients, HPG1860 has shown favorable risk-benefit data to support clinical development of combination therapy. Combined with favorable pharmacology, pharmacokinetic and preclinical safety profile of HPG7233, the company plans to file an IND for NASH around the third quarter of this year and is actively planning the combination study (HPG1860 and HPG7233) for NASH as well as HPG 7233 monotherapy for NASH and dyslipidemia indications.
About Hepagene Therapeutics, Inc.
Hepagene Therapeutics, Inc. a clinical stage biopharmaceutical company, devotes its drug discovery and development efforts towards discovering, developing and delivering innovative medicines that help patients prevail over liver diseases and other life-threatening diseases, especially non-alcoholic steatohepatitis (NASH), chronic Hepatitis B infection (HBV), liver cancer or advanced solid tumors.
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