CATO SMS has a successful track record in the conduct and execution of clinical studies across a number of gastrointestinal and hepatology disorders. We have the expertise to navigate the complexities toward market approval in these disease areas.

Nonalcoholic Steatohepatitis (NASH)

Many nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH, a more serious form of NAFLD) patients go undiagnosed and the actual prevalence of these conditions is unknown. It is estimated that between 10 million to 30 million people are afflicted by these disorders, yet there are no approved therapies available and the current first line treatment is lifestyle modification, including diet and exercise, followed by off-label generic drugs.

As the prevalence of NASH in the U.S. continues to increase, the need for effective therapies remains a crucial area of clinical investigation — coupled with notable challenges to NASH drug development, both from clinical and regulatory perspectives. NASH progresses slowly and it is difficult to identify patients that will progress from NAFLD to NASH

As the FDA is encouraging alternatives to liver biopsy, which is the current gold standard, CATO SMS’ clinical experts are available to support your NASH studies and design innovative clinical trials with non-histology endpoints and non-imaging biomarkers, developing the proper protocol design to enrich your study population and enhance subject enrollment.

NAFLD is considered the hepatic manifestation of insulin resistance, which is the hallmark of Type 2 diabetes (T2D). Given the similarities between NAFLD and T2D in terms of pathogenesis, underlying risk factors, and disease spectrum, CATO SMS’ experience in the management of T2D contributes to our intimate understanding of the disease.

Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) encompasses a cluster of disorders that cause chronic inflammation of the gastrointestinal tract, the most common forms being Crohn’s disease (CD) and ulcerative colitis (UC). IBD is an example of a prototypical complex disease that is challenging to accurately diagnose given that clinical symptoms and presentation can differ, for example, in patients of differing age and presence of other comorbidities.

CATO SMS experts work with sponsors to identify novel clinical trial design that focuses on pragmatic study design, versus traditional clinical efficacy evaluations.

Our team will advise you on how to employ novel forms of diagnostic enhancement tools, including artificial intelligence, while keeping you up to date on guideline evolution to meet the changing requirements of IBD trials.

As the paradigm shift progresses in IBD drug development, CATO SMS regulatory experts can establish the appropriate sponsor dialogue with regulatory agencies throughout the path to marketing approval.