HistoIndex SHG/TPE imaging and AI-based technology reveals dose-dependent effectiveness of Tropifexor for NASH patients in Nature Medicine

SINGAPORE, June 15, 2023 /PRNewswire/ -- HistoIndex has announced that its novel technology combining Second Harmonic Generation/Two-Photon Excitation (SHG/TPE) imaging with Artificial Intelligence (AI), in a post hoc analysis of the FLIGHT-FXR study (NCT02855164), enabled the detection of subtle interval changes in response to Tropifexor treatment in patients with Nonalcoholic steatohepatitis (NASH)¹. The findings of the clinical trial were published recently in Nature Medicine and provide another validation of HistoIndex's HistoHepa^© suite of image analysis tools, including qFibrosis^® and qSteatosis^®, designed to enhance the assessment and diagnosis of liver diseases through objective quantification of NASH features.

The findings are significant because they demonstrated the ability of SHG/TPE digital with AI analyses to detect subtle interval changes from response to treatment and to uncover finer details of the NASH pathobiology which cannot be detected using current fibrosis staging system and conventional microscopy. This is mainly because traditional liver histopathology assessment of fibrosis is qualitative, nonlinear between stages, and requires substantial changes over a relatively short time before a response can be detected.

The AI-based fully quantitative assessment was performed on unstained sections of 198 paired liver biopsies from 99 patients and the findings demonstrated that the treatment resulted in the improvement of liver fibrosis (using qFibrosis^®) and marked liver fat reduction (using qSteatosis^®). These biopsies were also assessed by conventional microscopy and traditional histologic scoring systems based on the categorical fibrosis stage. While the conventional methods showed that only a proportion of patients achieved fibrosis improvement, the AI-based qFibrosis^® algorithm showed a dose-dependent increase in the proportion of patients who achieved fibrosis improvement. Tropifexor treatment was also associated with a dose-dependent reduction in qSteatosis^®, which was also confirmed by a statistically significant correlation with the quantitative MRI-based evaluation of fat reduction.

Says Professor Arun J. Sanyal, Professor of medicine and director of the VCU Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, and principal author of the study, "The findings highlight the potential of AI-based SHG/TPE digital pathology that might transform how liver biopsies are assessed and evaluated to determine treatment efficacy and provide more precise and personalized diagnostics for individuals with liver disease. I am hopeful that these findings will encourage greater adoption of SHG/TPE digital pathology with AI analyses in liver biopsy evaluation, ultimately leading to improved patient outcomes".

HistoIndex is participating in the EASL 2023 Congress in Vienna and will be hosting a brunch meeting on 23^rd June 2023 from 10.30 am – 12 pm CET to discuss the use of stain-free digital pathology and AI as endpoints in NASH clinical trials. To register for the event, please contact events@histoindex.com.

About HistoIndex (www.histoindex.com)

Founded in 2010, HistoIndex is the first in the world to provide stain-free, fully automated imaging solutions for visualizing and quantifying morphological and architectural features of fibrosis in biological tissues. Using a digital pathology system comprising breakthrough biophotonic technology and ML/AI-based analysis, HistoIndex provides products and services in tissue research and diagnostics. HistoIndex equips researchers with reliable cutting-edge tools for their scientific work and clinicians with a stain-free, automated, consistent, and high throughput imaging platform to assist in speedy and accurate diagnosis of fibrosis and cancer. Based on revolutionary imaging solutions, the products developed have opened doors to new medical standards that aid in clinical diagnosis, benefit clinical research, and speed up pharmaceutical drug and treatment development.

Reference

1. Sanyal, A.J., Lopez, P., Lawitz, E.J. et al. Tropifexor for nonalcoholic steatohepatitis: an adaptive, randomized, placebo-controlled phase 2a/b trial. Nat Med 29, 392–400 (2023). https://doi.org/10.1038/s41591-022-02200-8