FDA awards Perspectum major grant for the qualification of its noninvasive diagnostic biomarker to reduce liver biopsy in drug trials
- September 27, 2022
Dallas, TX – September 27, 2022. Perspectum today announced The Food and Drug Administration (FDA) awarded the company a major grant to support the qualification of Perspectum’s imaging biomarker — cT1 — for diagnostic enrichment to reduce liver biopsy in clinical trials. Perspectum’s artificial intelligence-enhanced LiverMultiScan software, provides cT1, a quantitative biomarker for noninvasive identification of patients with “at-risk" nonalcoholic steatohepatitis (NASH).
Nonalcoholic fatty liver disease (NAFLD) is estimated to affect more than 80 million Americans, with almost 20 million having NASH, the more severe form of the disease1. NASH can lead to severe outcomes including cirrhosis, liver failure, liver cancer, liver transplant, and mortality as well as increased risk of heart disease, with no drug treatments currently available. Liver biopsy is currently the only approved test for trial inclusion and endpoint assessment in Phase 3 NASH clinical trials, but it is invasive, costly, not always reliable, insensitive to disease heterogeneity, and unacceptable to many patients.
Wayne Eskridge, CEO of Fatty Liver Foundation and a vocal advocate for improving drug development processes for fatty liver disease2 commented, “The FDA’s generous support for qualification of LiverMultiScan cT1 as a diagnostic enrichment tool, demonstrates a welcome commitment to offering a safer, more accurate alternative to liver biopsy for clinical trial participants, encouraging more patient participation and potentially accelerating drug development. LiverMultiScan also has potential for early screening to help identify patients at the highest risk of advanced liver disease”.
Studies have shown that cT1 can identify patients with “at-risk” NASH, namely those at high risk of progression to severe disease3 with higher accuracy than other noninvasive imaging tests4 Hence, cT1 has been proposed as a diagnostic enrichment biomarker, in conjunction with clinical risk factors, to identify participants who are more likely to have liver histopathologic findings appropriate for inclusion in NASH clinical trials. The qualification plan for cT1 in the biomarker qualification program is the first-of-its-kind to be accepted by the FDA for NASH drug development5.
Perspectum will use the FDA funding to complete their biopsy-paired cross-sectional observational study (NQUAN6) in 225 patients across at least 5 sites in the U.S., replicating non-U.S. studies that have already demonstrated the utility of cT1 for identifying this target patient population. These “at-risk” patients have a histological NAFLD Activity Score (NAS) of 4 or above and liver fibrosis stage 2 or above. Together with a previous award for the technical evaluation of cT1 (CATE-NASH5 ), Perspectum has now received almost $500,000 in FDA funds for cT1 research.
“We are grateful to the FDA for this award, which will help qualify our noninvasive imaging technology for diagnostic enrichment,” said Matt Kelly, PhD, Chief Innovation Officer at Perspectum. “LiverMultiScan can positively impact drug companies by making clinical trials easier, faster, and less expensive, while affording patients with liver disease access to a pain-free, noninvasive procedure when participating in clinical trials.”
Estes, C., et al. (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology, 67(1), 123–133.
Andersson, A., et al. (2021). Clinical utility of MRI biomarkers for identifying NASH patients at high risk of progression: A multi-center pooled data and meta-analysis. Clinical Gastroenterology and Hepatology, Advance online publication. https://doi.org/10.1016/j.cgh.2021.09.041
Imajo, K., et al. (2021). Quantitative multiparametric MRI can aid NASH diagnosis in a Japanese cohort. World Journal of Gastroenterology, 27(7), 609–623.
Non-Invasive Quantification of Liver Health in NASH (N-QUAN): https://clinicaltrials.gov/ct2/show/NCT04054310
- Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH):
LiverMultiScan is a novel technology that addresses a critical unmet need for noninvasive techniques to diagnose and monitor patients with chronic liver diseases such as nonalcoholic steatohepatitis, autoimmune hepatitis, or viral hepatitis. LiverMultiScan uses a noninvasive multiparametric magnetic resonance imaging (MRI) scan to accurately assess signs of liver disease by simultaneously quantifying liver disease activity and severity (using a proprietary MRI metric, cT1®), fat, and iron content, offering a complete picture of liver health.
About the project
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD007771 totalling $239,712 with 20 percent funded by FDA/HHS and $931,010 and 80 percent funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
Perspectum, a global medical technology company with offices in the U.K., the U.S., Portugal, and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic diseases, multi-organ pathology, and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers, and technologists, Perspectum offers a way to manage complex health problems at scale.
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