Hepagene Therapeutics has commenced the Phase IIa RISE clinical trial of HPG1860 to treat non-alcoholic steatohepatitis (NASH) patients.
For the study, the company has screened the first participant in the US.
HPG1860 is an investigational, potent, selective, and full farnesoid X receptor (FXR) agonist, non-bile acid. It is currently under development to treat NASH and cholestatic hepatitis.
The double-blind, multi-centre, randomised, placebo-controlled Phase IIa clinical trial will run for 12 weeks and assess the tolerability, efficacy, and safety of HPG1860 in NASH patients.
It will recruit 80 participants, with each cohort containing 20 patients, in the US. The subjects will receive a placebo or 3mg, 5mg and 8mg doses of HPG1860.
Hepagene chief medical officer Que Liu said: “We are thrilled to initiate the HPG1860 phase IIa RISE trial in NASH patients. We have recently reported positive phase I data of HPG1860 at the 2021 AASLD meeting. HPG1860 displayed a benign safety profile with robust target engagement through C4 reduction and FGF19 activation.
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“We look forward to assessing safety and efficacy of HPG1860 in the RISE study and advancing HPG1860 as a potential therapy for NASH patients.”
In the RISE study, participants will be orally administered with placebo or HPG1860 once a day.
Safety and tolerability of the investigational drug will be the trial’s primary endpoint while assessment of changes in liver fat content (LFC) after treatment with HPG1860 will be the secondary goal.
Furthermore, changes in HPG1860’s biomarkers and pharmacokinetic profile will be some of the other endpoints of the study.
An estimated 20%-25% of patients with non-alcoholic fatty liver disease (NAFLD) will progress to NASH.
This October, Boston Pharmaceuticals dosed the first subject in a Phase IIa clinical trial of its drug candidate, BOS-580, to treat NAFLD and/or NASH patients.