Data from MAESTRO-NASH study revealed that HistoIndex’s technology identified larger percentage of patients who showed improvement after Resmetirom treatment, compared to manual semi-quantitative pathologist-reads

Company and collaborators will present 14 accepted abstracts at EASL Congress 2023

Presentations reinforce HistoIndex leadership in NASH digital pathology with ground-breaking, validated AI-driven solutions

SINGAPORE, June 21, 2023 /PRNewswire/ — HistoIndex today announced that the Company, alongside its collaborators, will present new data on its novel stain-free tissue imaging technology using clinically validated artificial intelligence (AI) algorithms at the EASL Congress, taking place June 21-24, 2023. The data demonstrate how HistoIndex’s stain-free Second Harmonic Generation/Two-Photon Excitation (SHG/TPE) imaging and AI technologies can be used in preclinical through late-stage clinical development to quantify and analyze morphological features of liver biopsy samples across Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD). HistoIndex’s patented imaging technology and methodologies will be featured in 14 accepted abstracts, including one oral presentation by Dr. Timothy J. Kendall.

The studies presented at the EASL Congress demonstrate the successful application of SHG/TPE imaging technology combined with AI analysis in multiple clinical trials focused on NASH and NAFLD. HistoIndex’s breakthrough lies in its AI algorithm, which is trained on SHG/TPE images of unstained biopsies. By harnessing the power of AI, HistoIndex’s digital pathology solution reveals intricate details of NASH histopathology, providing a quantitative and continuous value (qFibrosis^®) that surpasses the limitations of the current gold standard of pathological assessment. In contrast to manual assessments of stained tissue biopsies and categorical scoring systems, HistoIndex’s approach eliminates variability and enhances the accuracy of diagnosis.

“HistoIndex’s participation in the EASL Congress and the acceptance of our research partners’ 14 abstract submissions exemplify our unwavering commitment in advancing the field of NASH digital pathology,” said Dr. Gideon Ho, Ph.D., CEO at HistoIndex. 

Of particular significance is the study conducted by Dr. Stephen Harrison, M.D., titled “Artificial intelligence to measure fibrosis change on liver biopsy in MAESTRO-NASH: a Phase 3 52-week serial liver biopsy study in 966 patients with NASH treated with resmetirom or placebo.” The study demonstrated that the percentage of patients showing improvement, as assessed using qFibrosis^®, was higher compared to evaluations by central pathologists with significant correlations observed between reduction in qFibrosis^® and reduction in PDFF, ALT, AST, and ELF.

“We have seen from the multitude of published data that SHG/TPE imaging with AI analyses can help augment pathologist reads and if we can fully quantify the key features of NASH activity and fibrosis using innovative stain-free AI-based digital pathology; and understand their correlation with outcomes, we will be better equipped to design more effective clinical trials that facilitate regulatory approvals in drug development,” said Dr. Stephen Harrison, Chairman, and Founder at Pinnacle Clinical Research, Chairman and Co-Founder at Summit Clinical Research and Visiting Professor of Hepatology at the Radcliffe Department of Medicine, University of Oxford.

HistoIndex is participating in the EASL Congress 2023 in Vienna and will be hosting a brunch meeting on 23rd 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.

Further information on key abstracts featuring HistoIndex technology that will be presented at EASL can be found below:

Abstract session (June 23, 05:45 PM – 06:00 PM CEST, Room Lehar 4)
Title: Digital pathology using stain-free imaging indices allows direct prediction of all-cause mortality, hepatic decompensation and hepatocellular carcinoma development in patients with non-alcoholic fatty liver disease
Presentation Number: OS-087
Presenter: Dr. Timothy J. Kendall
Session: NAFLD: Clinical aspects 

Poster Tour (24 June 2023 15:30 – 15:37 CEST, Poster area)
Title: A deep exploration of bridging fibrosis evolution and individual septa parameters in NASH using quantitative second harmonic generation imaging reveals fibrosis changes in natural history and treatment-induced not seen with conventional histology
Poster Number: TOP-076
Presenter: Prof. Nikolai Naoumov
Session: NAFLD: Therapy

Poster presentations

Wednesday, June 21, 2023, From 9AM CEST (Poster area)

Title: Artificial intelligence to measure fibrosis change on liver biopsy in MAESTRO-NASH a phase 3 52-week serial liver biopsy study in 966 patients with NASH treated with resmetirom or placebo
Poster Number: LBP-017
Presenter: Dr. Stephen Harrison
Session & Location: Late-breaker

Title: Artificial Intelligence analysis of liver biopsies in pre-cirrhotic NASH: qFibrosis explained
Poster Number: WED-236
Presenter: Dr. Pol Boudes
Session: Fibrosis / Stellate Cell Biology

Title: Advancement of artificial intelligence in digital pathology: from exploratory end point to primary end point in non-alcoholic steatohepatitis clinical trials
Poster Number: WED-237
Presenter: Dr. Dean Tai
Session: Fibrosis / Stellate Cell Biology

Title: Repeatability and reproducibility assessment and its acceptable standard error of means for qFibrosis system in multi-site NASH clinical trials
Poster Number: WED-238
Presenter: Dr. Jason Pik Eu Chang
Session: Fibrosis / Stellate Cell Biology

Title: Validation and utility of artificial intelligence-based zonal annotations as an additional assessment tool for the histopathologic review of fibrosis in non-alcoholic steatohepatitis patients
Poster Number: WED-436
Presenter: Dr. Gwyneth Soon
Session: NAFLD: Experimental and pathophysiology

Title: Collagen co-localized with macrovesicular steatosis better differentiates fibrosis progression in non-alcoholic fatty liver disease mouse models
Poster Number: WED-438
Presenter: Ms. XiaoXiao Wang
Session: NAFLD: Experimental and pathophysiology

Title: Quantification of vessel and bile duct parameters using Second Harmonic Generation in patients with NAFLD across fibrosis stages
Poster Number: WED-443
Presenter: Dr. Dean Tai
Session: NAFLD: Experimental and pathophysiology

Title: Combination therapy of TERN-501, a selective agonist of thyroid hormone receptor (THR) beta with TERN-101, a farnesoid X receptor (FXR) agonist improves nonalcoholic steatohepatitis (NASH) in a GAN diet-induced and biopsy-confirmed mouse model
Poster Number: WED-445
Presenter: Dr. Kerry Russell
Session: NAFLD: Experimental and pathophysiology

Thursday, June 22, 2023, From 9AM CEST (Poster area)

Title: Digital pathology using stain-free imaging indices as a tool for fibrosis quantification in patients with congestive hepatopathy
Poster Number: THU-333
Presenter: Prof. Matthew Yeh
Session: Rare liver diseases (including paediatric and genetic)

Title: Digital pathology with artificial intelligence analyses provides deeper insights into lifestyle intervention-induced fibrosis regression in NASH
Poster Number: THU-428
Presenter: Dr. Dean Tai
Session: NAFLD: Clinical aspects except therapy

Friday, June 23, 2023, From 9AM CEST (Poster area)

Title: Artificial intelligence assisted qFibrosis as a pathological “biomarker” to evaluate disease severity in patients with hepatocellular carcinoma
Poster Number: FRI-290
Presenter: Dr. Dean Tai
Session: Liver tumours: Clinical aspects

Title: Hepatic fat and liver volume reductions-impact on non-alcoholic steatohepatitis trials and potential solutions using concomitant fibrosis with ballooning with fibrosis
Poster Number: FRI-518
Presenter: Dr. Stephen Harrison
Session: NAFLD: Therapy

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.

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