HeparDx™ is an investigational MASH (NASH) activity and liver fibrosis blood test designed to diagnose and stage patients, detect at-risk MASH and monitor treatment response to therapy

The data presentations add further evidence supporting HeparDx™ as an accurate blood test to detect liver-specific metabolic dysfunction-associated steatohepatitis (MASH)New findings independently correlate PLIN2 with inflammation and lobular ballooning in a 198-patient analysis from the previous prospective study published in Guti

LONDON and WINTER SPRINGS, Fla., June 4, 2024 /PRNewswire/ — PR Newswire – MetaDeq Ltd. and MetaDeq Diagnostics, Inc., a private medical diagnostic company developing tests for MASH (fatty liver) and liver fibrosis, announced that two posters will be presented at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The presented data shed new light on the PLIN2 component of the HeparDx™ diagnostic blood test and provide a further understanding of PLIN2’s mechanism of action for detecting MASH. The abstracts can be found on the EASL website at www.easlcongress.eu and will be available for viewing on Wednesday June 5, 2024 at 8 :30am CEST.

HeparDx™ is able to identify and quantify inflammation and ballooning in blood monocytes with high accuracy and correlation to liver cells as assessed by liver biopsy. This detection appears to be liver-specific and not associated with inflammation seen in subjects with cardiovascular disease (CVD). There is a clear unmet medical need to improve accuracy for non-invasive tests (NITs) for MASH. HeparDx™ is a blood test comprised of two biomarkers, one for inflammation and ballooning associated with MASH activity (PLIN2), and one for liver fibrosis (RAB14). MetaDeq believes its diagnostic blood test ultimately may enable physicians to: 1. Diagnose MASH patients before significant disease progression occurs, 2. Use it as a pre-treatment medical decision-making tool, and 3. Monitor patient response to treatment.

Prof. Sven Franque, abstract author and collaborating clinician, comments: “After encouraging data published in 2023, at this year’s Liver Congress in Milan, Poster WED-296 undertakes an important analysis to determine if PLIN2 over-expression occurs in other tissues. Cardiac tissue from subjects with cardiovascular disease generally has inflammation as a hallmark characteristic. In this dataset, PLIN2 levels are elevated in liver tissue in subjects with MASH, but not in subjects with cardiac disease; this helps provide evidence that HeparDx™ appears to be liver-specific. I look forward to seeing continued data generation in additional patient cohorts throughout this year.”

POSTER PRESENTATIONS

Title: HeparDx™ (by MetaDeq, Inc.) is a reliable biomarker of MASH capable of detecting the presence of inflammation and ballooning
Authors: Giulia Angelini, Sara Russo, Erminia Lembo, Ornella Verrastro, Antonio Liguori, Stephen Harrison, Aldo Trylesinski, Luca Miele, Geltrude Mingrone
Poster Number: WED-215
Date/Time: Wednesday, June 5th, 8:30 am CEST
Summary: PLIN2 expression is significantly increased in subjects with at-risk MASH (NAS ≥4 and clinically significant fibrosis) compared with subjects without MASH. In 198 subjects with histologically proven at-risk MASH, HeparDx™ analysis for the detection of presence/absence of MASH produced an AUROC of 96.8% vs. liver biopsy, with a sensitivity and specificity of 93.5% and 90.2%, respectively. HeparDx™ was able to detect inflammation and ballooning as individual components, each with high sensitivity and specificity.

Title: PLIN2 is a specific marker for liver related disease
Authors: Giulia Angelini, Sara Russo, Federico Biscetti, Andrea Flex, Jérôme Boursier, Sven Francque, Aldo Trylesinski, Stephen Harrison, Geltrude Mingrone
Poster Number: WED-296
Date/Time: Wednesday, June 5th, 8:30 am CEST
Summary: Plasma PLIN2 is significantly higher in subjects with MASH as compared to subjects without MASH. In 100 subjects analyzed, HeparDx™ clearly showed the ability to detect MASH activity in the liver, but in subjects with CVD and early atherosclerosis, no significantly elevated levels of PLIN2 were detected. Hence, PLIN2 appears to be specific for liver activity related to MASH and is not confounded with inflammation in other tissues, such as cardiac.

Aldo Trylesinski, M.D., Consulting Chief Medical Officer, comments: “The two posters presented at EASL further validate the scientific basis behind HeparDx™ as a non-invasive blood test aimed to detect MASH activity, their individual components and liver fibrosis. Further validation in other patient cohorts is currently ongoing, but up to now, the evidence described in these posters, coupled with the data published in Gut earlier last year, point to a very encouraging signal.”

In Memory and Acknowledgement: Earlier this year, the liver community lost a brilliant physician, leader, clinical trial investigator and true champion of patients, Dr. and Colonel (Ret.) Stephen A. Harrison. With Stephen’s passing, we at MetaDeq, and many, many others, lost a friend and advisor. Stephen’s work and insight into liver diseases will continue to inspire us. Stephen had been serving as Chair of the MetaDeq Scientific Advisory Board and was an early believer in our technology. 

About MASH (NASH)

Metabolic dysfunction-associated steatohepatitis (MASH) is a leading cause of cirrhosis, liver failure, liver transplant, and hepatocellular carcinoma. Liver biopsy is the diagnostic reference standard, but it is expensive, time consuming, and carries multiple risks to the patient. With the first FDA-approved therapeutic on the market, the need for a highly accurate and reliable non-invasive test (NIT) is imperative to diagnose and monitor patients on therapy. In the U.S., over 25% of adults have metabolic dysfunction-associated steatotic liver disease (MASLD), of which 20%, or 12 million adults, will progress to MASHii. In June 2023, the American Diabetes Association recommended all 28 million people with Type 2 diabetes be tested for MASLD/MASHiii.

About HeparDx

HeparDx™ is an investigational novel blood test to accurately diagnose, stage, and monitor MASH being developed by MetaDeq Diagnostics. HeparDx™ includes two biomarkers correlated with MASH activity and fibrosis in the liver to accurately diagnose MASH patients and potentially replace liver biopsies. Clinical data from a prospective study in 250 patients undergoing liver biopsies has been peer-reviewed and published in Gut1, a leading medical journal, and multiple additional abstracts have been presented at medical congresses. HeparDx™ appears to have the potential to measure, independently, each inflammation and ballooning component in MASH vs. only steatohepatitis.

About MetaDeq Diagnostics

MetaDeq is committed to delivering diagnostics that help physicians identify, diagnose, stage and monitor MASLD and MASH patients with a simple and accurate blood test. MetaDeq’s lead product is HeparDx™, a blood test based on two biomarkers to detect MASH activity and liver fibrosis. For more information, please visit: www.metadeq.com.

Contacts

i Gut Feb 2023, 72 (2) 392-403; DOI: 10.1136/gutjnl-2022-327498

ii Int J Mol Sci, 2019; www.liverfoundation.org; Clin Diabetes and Endocrinology, 2020; Gosalia, et al, Diagnostics 2022

iii https://diabetes.org/newsroom/american-diabetes-association-releases-guideline-update-NAFLD-diabetes

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SOURCE Metadeq