Non-Invasive Solutions for Your NASH Clinical Trials

Posted: September 16, 2021

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Biomarker Assays for NASH Clinical Trials

NASH Clinical Trials

Non-Invasive Biomarkers for Fatty Liver Disease Research

The Problem:

In early phase NASH trials, performing liver biopsies to evaluate the effect of a potential drug candidate is not always practical or feasible.

  • These relatively short-duration early trials may not result in significant changes in liver histology.
  • Traditional non-invasive serum biomarkers used in NASH clinical trials, such as serum ALT and AST, are notoriously insensitive and non-specific, and do not always accurately reflect the extent of liver injury.
  • Recent NASH drug failures and setbacks highlight the need for collecting data on multiple biomarkers to provide mechanistic and biological information on drug candidates.
  • Fibrosis biomarkers may not reflect ongoing active disease and and may not be adequate for determination of possible drug effects.
  • Specific and comprehensive data are critical for decision making when deciding on future clinical trials.

The Solution:

Non-Invasive, mechanistic biomarkers that are reflective and predictive of changes in liver histology

  • Serum CK18 (M65®) and ccK18 (M30®) measure hepatocyte apoptosis and necrosis.
  • Apoptosis and necrosis are underlying mechanisms that are directly involved in the pathogenesis of NAFLD.
  • NASH is a multifactorial disease and multiple biomarker readouts of disease pathogenesis can indicate changes in biological pathways of the disease.
  • Ongoing cell death indicates ongoing pathogenesis in NASH.
  • Changes in CK18 and ccK18 levels may therefore be early indicators for changes in disease activity in response to drug treatment.
  • Changes in serum CK18 and ccK18 levels have been shown to correlate with histological changes/endpoints in the liver.
  • CK18 biomarkers are used widely in NASH clinical trials as a secondary endpoint to assess drug efficacy
  • CK18 can be used for prescreening subjects in clinical trials to help identify individuals with “at risk” NASH (NAS ≤ 4, and F2-3)

DiaPharma offers additional non-invasive biomarker assays for NAFLD/NASH, AH, and DILI research. Incorporating these biomarkers into your research adds valuable information about changes in disease activity, which could decrease time and costs of studies. M30® and M65® Cytokeratin 18 (CK18)ELISAs, Osteopontin, Mac-2 Binding Protein, sCD163, L-FABP, FGF-19, and FGF-21 are just a few of the biomarker assays offered by DiaPharma to help your drug candidate move forward.

If you’d like to speak with an expert about which biomarker would be most useful for your project, call 800.447.3846 or email us today.

For research use only in the U.S. and Canada. Not for use in diagnostic procedures.


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