Quantitative Approaches to Accelerate MASH Drug Discovery and Development.

ABSTRACT: Metabolic dysfunction-associated steatohepatitis (MASH) is a widespread liver condition that leads to cirrhosis, hepatic carcinoma, and increased mortality rates. In MASH, the diagnosis and accelerated approval of drugs are dependent on changes in histological endpoints; full approval requires lengthy outcomes trials. This requirement for biopsies complicates and constrains clinical development. While the use of noninvasive biomarkers to aid in diagnosis and prognosis is prevalent in MASH trials, interpretation of these data is not straightforward. Due to the complexity of the disease and heterogeneity of the patient population, a single biomarker may not fully capture the changes in the pathobiology with disease progression or with pharmacological interventions. No biomarker or collection

SUBMITTER: Abouelhassan Y 

PROVIDER: S-EPMC12641080 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature