Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), can lead to liver cirrhosis and related complications, including cancer. Although NAFLD affects approximately 25% of the global population and is increasing in prevalence with rising rates of type II diabetes, metabolic syndrome, and obesity, there are currently no approved therapies for NASH/MASH.
Multiple compounds are in development for the treatment of NASH/MASH, but barriers to drug development include the lack of a gold standard measure of NAFLD activity and validated outcomes that are responsive to change following effective therapeutic intervention.
Systematically review the operating properties of histopathologic outcome measures
Standardize histopathologic scoring conventions
Improve the reliability of histopathologic assessment
Experience spanning more than 30 years in the design and conduct of early to late-phase multicentre global clinical trials
Collaborations with internationally recognized liver disease experts
A vast global network of clinical investigators and their NASH/MASH patient population
Central imaging histopathology solutions and processes to block, cut, stain, and digitize liver biopsies for central review
Highly trained central histopathology readers whose disease-specific expertise helps to reduce histopathologic outcome variability
Scientific collaborators and strategic scientific partnerships that facilitate the design and incorporation of translational medicine research (e.g., immunohistochemistry) into clinical trials
Biostatisticians whose expertise in clinical trials ensures high-quality and clinically relevant results