Sonic Incytes Announces Clinical Trial Data Comparing Velacur™️ and FibroScan®
November 3, 2022
Sonic Incytes Medical Corp. is pleased to announce clinical data from a prospective multi-center study comparing the effectiveness of Velacur™️ and FibroScan® in measuring liver fibrosis and fat in patients with suspected NAFLD (non-alcoholic fatty liver disease) and NASH (non-alcoholic steatohepatitis).
The results confirmed earlier findings that Velacur can effectively differentiate between various stages of elasticity (fibrosis) and attenuation (fat) when using MRI (magnetic resonance imaging) as a reference standard. In terms of comparative results, Velacur was found to be more effective than FibroScan at measuring liver fat (steatosis), and achieved statistical significance over FibroScan in patients with severe steatosis (defined as having 20% or greater liver fat). With respect to stiffness, Velacur was found to be equally effective as FibroScan at all fibrosis stages.
133 patients were enrolled at five centers in the US and Canada and stratified by stage of fibrosis and percentage of liver fat. All patients underwent scans with Velacur, FibroScan (conventional transient elastography by Echosens), MRE (magnetic resonance elastography), and MRI-PDFF (magnetic resonance imaging proton density fat fraction). MRE and MRI-PDFF are established tools for quantitative imaging and were used as reference standards for liver stiffness and fat, respectively.
“As the prevalence of fatty liver disease continues to skyrocket, the need for effective, non-invasive and accessible tools to diagnose and manage this condition is very high,” stated Dr. Nezam Afdhal, Head of Gastroenterology at Beth Israel Deaconess Medical Center and one of the investigators of the study. “As NASH therapeutics come to market, tools like Velacur will play a pivotal role in qualifying patients for drug therapy and monitoring their effectiveness.”
Trial sites included the University of California, San Diego; Southern California Research Center; Beth Israel Deaconess Medical Center; Vancouver Coastal Health Research Institute, and Gastrointestinal Research Institute.