Alimentiv’s extensive experience in designing and conducting IBD clinical trials is helping to bring new therapies to market for the treatment of nonalcoholic steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH), which is 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.
Multiple compounds are in development for the treatment of NASH, 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.
Alimentiv is collaborating with world-renowned hepatologists and histopathologists to:
- Systematically review the operating properties of histopathologic outcome measures
- Standardize histopathologic scoring conventions
- Improve the reliability of histopathologic assessment
Alimentiv can support your NASH clinical development program through our:
- 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
- Vast global network of clinical investigators and their NASH 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