China-based liver disease specialist Hepagene Therapeutics (HK) Limited has revealed positive data from the Phase IIa clinical study of its in-house developed FXR agonist HPG1860 in non-alcoholic steatohepatitis (NASH). The results highlight the drug’s potential in addressing this metabolic liver disease.
Phase IIa RISE Study Results
The multi-center, randomized, double-blind, placebo-controlled Phase IIa RISE study assessed the safety, tolerability, efficacy, and pharmacokinetics of HPG1860. A total of 87 adult non-cirrhotic NASH patients were enrolled to receive HPG1860 at doses of 3 mg, 5 mg, 8 mg, or placebo once daily. After 12 weeks of treatment, the average relative changes in visceral fat content from baseline were 0.68% (placebo), -20.15% (3 mg, p=0.002), -7.08% (5 mg, p=0.244), and -38.64% (8 mg, p<0.0001). No significant increase in LDL cholesterol levels was observed across all groups, and no dose-related decrease in ALT levels was noted in patients with high baseline ALT. HPG1860 was generally well-tolerated, with most adverse events being mild to moderate.
HPG1860 Mechanism and Development
HPG1860 is a highly selective next-generation FXR agonist with a non-bile acid structure. FXR is a key regulator of bile acid homeostasis, and its expression is often down-regulated during NASH progression. FXR also plays a significant role in inflammation regulation. Preclinical studies and early clinical trials have demonstrated HPG1860’s excellent safety and efficacy profile.
Future Development Plans
Hepagene, a clinical-stage biotech focused on NASH, chronic hepatitis B, and rare liver diseases, plans to continue the clinical development of HPG1860 based on these positive results. The company also intends to initiate a clinical study combining HPG1860 with HPG7233, a thyroid β (THR-β) receptor agonist, to further explore its potential in treating NASH.-Fineline Info & Tech
