[Whitepaper] The True Cost of Imaging in Phase 3 NASH Trials

Whitepaper: True Cost of Imaging in Phase 3 NASH Trials

Executive Summary Non-alcoholic steatohepatitis (NASH) presents a major challenge in drug development. Diagnosis and identification of patients with NASH is notoriously difficult due to a long asymptomatic period and lack of available treatment options. The current gold standard for diagnosis, liver biopsy, has inherent limitations of being invasive, expensive and often imprecise. Imaging-based biomarkers are effective tools to screen subjects for NASH and evaluate efficacy of therapies. To date, just a handful of NASH drugs have made it to Phase 3 development, and each has experienced either recruitment delays or changes to endpoints mid-study. Although it appears some sponsors may have charted an earlier course to success to the first FDA approved NASH drug, the shifting clinical trial landscape and increasing competition for patients demands companies continue to run smarter, faster, and leaner clinical trials if they are to successfully navigate towards an approved NASH drug. Knowing how to integrate the right imaging tools into NASH trials gives sponsors the enhanced data needed to successfully develop an approved NASH drug on time and within budget. Imaging represents a patient friendly, cost-effective tool to accelerate patient recruitment, enrich for the right NASH patients, and provide early efficacy readouts as well as long-term safety monitoring. This whitepaper outlines how to cost-effectively use LiverMultiScan® in NASH clinical trials as a screening and monitoring tool in order to lower enrollment costs, accelerate drug development, and reduce the burden of invasive testing on patients.