What Are the Emerging Noninvasive Biomarkers in NASH?

Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical Covance NASH Liver Disease Blogprocedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical and costly.

The ultimate goal is to find noninvasive biomarkers that clearly show if the patient has steatohepatitis or liver fibrosis associated with nonalcoholic fatty liver disease (NAFLD). Recent studies suggest that nuclear magnetic resonance (NMR) spectroscopy, microRNA tests and genotyping may prove to be useful tools. Incorporating additional biomarkers into clinical trials can give biopharmaceutical companies an early indication of whether a compound is efficacious — and provide the confidence to move forward to the next phase of clinical testing. Continue reading

How to Navigate Pre-Clinical Issues in NASH Development

The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent Pre-Clinical Issues in NASH Development - Covance Blog. Image of molecules.models, but they must weigh factors such as customization versus speed before deciding on the best approach.

Some of the challenges include:

  • Diet: There is no prevailing wisdom in the field suggesting that one induction diet is superior to another.
  • Duration of disease induction: Depending on the type of diet, it will take 6 to 9 months for models to exhibit NASH-like features.
  • Translation: Novel biomarkers used in human clinical trials need further validation in rodent models.

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