Trial success for three non-invasive liver health biomarkers

Scientist working at a desk to show First NHS patient receives Chiesi's stem cell treatment

New data published in PLOS One, demonstrate the utility and variability of three non-invasive liver health biomarkers, and highlight excellent reproducibility of iron-corrected T1 (cT1) in comparison to other methods.

Whilst several non-invasive biomarkers have been evaluated in NASH clinical trials recently, this is the first time that their utility to assess drug efficacy has been shown. Galectin’s GR-MD-02 is a novel therapy currently in Phase 3 trials for the treatment of NASH with compensated cirrhosis.

This study was a phase 2 randomised clinical trial of the compound in pre-cirrhotic NASH patients, who were assessed by measuring inflammation and fibrosis with cT1, liver stiffness with Magnetic Resonance Elastography (MRE) and also with shear-wave ultrasonic elastography (Fibroscan’s Liver Stiffness Measurement: LSM).

The primary outcome, cT1, was shown to have excellent reproducibility with a low coefficient of variation (CoV) of 3.1% in comparison to MRE and LSM.

These data further support the utility of cT1, as a low CoV is important for detecting even small changes in fibro-inflammatory activity in the setting of a clinical trial. With the growing prevalence of non-alcoholic fatty liver disease (NAFLD) and preference for reducing reliance on liver biopsy, non-invasive, quantitative MR biomarkers of liver health are of increasing utility.

The lead investigator for the study, Professor Stephen Harrison, commented: “In monitoring longitudinal change over time in NASH clinical trials, it is important to have a test with a low CoV. This study shows that cT1 can be reliably assessed and has utility in longitudinal monitoring of change in patients with NASH with advanced fibrosis. It is my hope that these factors together should reduce the need for liver biopsies in both trials and treatment.”

Dr Rajarshi Banerjee, CEO of Perspectum Diagnostics, commented “We are glad to see an increasing body of evidence to support the use of cT1 in the assessment of NAFLD and NASH.”