The multicentre, double-blinded, randomised trial will assess the safety and efficacy of rencofilstat in 336 subjects.
It is being carried out at up to 121 sites in seven countries, with 85 of them in the US.
To focus on NASH patients with more advanced fibrosis, subjects who are part of the trial will be biopsied to confirm either F2 or F3.
A minimum of 60% of the subjects enrolled in the trial will be F3.
Participants will be given either oral once-a-day doses of 75mg, 150mg, or 225mg of rencofilstat or a placebo for 12 months.
As endpoints, the trial will assess improvements in fibrosis and steatosis in trial subjects.
A rise in fibrosis scores by one point without steatosis worsening, or an improvement of steatosis without fibrosis worsening, will be the trial’s overall primary endpoint.
The key study endpoint is histologic and will be evaluated by variations in the biopsy.
The trial will also analyse various other non-invasive markers such as NASH efficacy biomarkers, magnetic resonance elastography, and multiomics.
A lead drug candidate of the company, rencofilstat is an inhibitor of cyclophilins.
In experimental models of NASH, the drug showed to lower liver fibrosis and the burden of hepatocellular carcinoma tumours.
Rencofilstat was found to have antiviral activities toward hepatitis B (HBV), C (HCV), and D (HDV) viruses through various mechanisms in nonclinical studies.
Hepion chief medical officer Todd Hobbs said: “We anticipate full enrolment in 12 to 14 months, as this is a large and rigorously controlled trial with a 60-day screening period including multiple laboratory analyses, Fibroscan evaluation, liver biopsy, and MRE.
“Additionally, we received Fast Track designation from the FDA in November of 2021; this allows for the submission of study reports as they are obtained, as well as more frequent engagement with the Agency, which should provide for [a] smoother transition from Phase IIb to Phase III.”