HistoIndex's AI-Based Platform Demonstrates Zonal Quantification and Histological Characterization of Fibrosis Improvements in Patients With Nonalcoholic Steatohepatitis (NASH)
HistoIndex's Second Harmonic Generation (SHG) stain-free digital pathology platform for the automated quantitative assessment of histological features has shown promising analyses that indicate post-treatment improvements in fibrosis. This was stated at an Oral Presentation entitled, "Safety and Efficacy of Tropifexor in Patients with Fibrotic Nonalcoholic Steatohepatitis: 48-week Results from Part C of the Phase 2 FLIGHT-FXR Study", during AASLD's The Liver Meeting Digital Experience™ 2020.
HistoIndex's quantitative analyses revealed novel aspects of improvement of NASH fibrosis beyond the conventional scoring of liver biopsies for Tropifexor-treated patients. In addition, zonal quantification of fibrosis changes showed a fibrosis improvement in the intermediary area of Zone 2 for Tropifexor-treated patients compared with placebo. This reinforces the ability of SHG to quantify incremental changes in fibrosis along with other NASH characteristics in various regions of the liver biopsy on a continuous scale, which is critical in assessing post-treatment responses. Results of zonal quantification using SHG in NASH Phase 2 clinical trials with other pharmaceutical companies have been previously reported and presented.
Says Professor Arun Sanyal, Professor of the Internal Medicine Department, Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University, and Lead Investigator of the study, "Classical histological staging systems measure the amount and distribution of fibrosis and require a substantial amount of change before a change can be identified. It is becoming increasingly clear that fibrosis evolution and resolution are highly dynamic processes. This will necessitate more dynamic measures of fibrosis change in clinical trials. The use of SHG signals to measure collagen fibrillar properties in this study substantiates the notion that such changes can be identified by such methods. This opens the possibility to measure changes in fibrosis in clinical trials in a manner which more closely reflects the dynamic nature of fibrosis than classical methods."
Ongoing SHG quantitative analysis from this and other existing Phase 2 and 3 studies could further characterize treatment-related changes beyond conventional histological assessments and help to harmonize key biochemical and histologic results in NASH clinical trials. "We will continue to support all current and new clinical trials/studies using our SHG imaging and AI-based analysis capabilities, in collaboration with our partners, to advance scientific efforts in the area of NASH. Our objective is to contribute to efforts aimed at finding a treatment solution for patients with this fast-progressing complex disease," says Dr. Dean Tai, Chief Scientific Officer of HistoIndex.
The presentation by Prof Sanyal, No. 139, Safety and Efficacy of Tropifexor in Patients with Fibrotic Nonalcoholic Steatohepatitis: 48-week Results from Part C of the Phase 2 FLIGHT-FXR Study, is available to registered delegates of The Liver Meeting Digital Experience™ 2020.
About Zonal Quantification
Zonal quantification is an automated feature-based assessment that spontaneously identifies minute changes – either regression or progression – in steatosis and fibrosis in specific regions of the hepatic lobules within the same unstained biopsy slide. Concomitant measurements of such changes on a continuous scale reveals mechanism of action (MOA) and is vital for the assessment of therapeutic efficacy.
Note to Editors
FLIGHT-FXR (NCT02855164) is a phase 2, randomized, double-blind, placebo (PBO)-controlled, 3-part, adaptive-design study to assess the safety, tolerability, and efficacy of multiple doses of TXR in patients with NASH (Sanyal A, et al. Hepatology. 2018;68 (suppl):1460A).