Perspectum announced two research studies that were recently published, bringing hope to people with metabolic dysfunction-associated steatohepatitis (MASH). This research affirms the utility of quantitative MRI imaging as an alternative to liver biopsy in some clinical trials and in patient care management.
The first study, supported by the U.S. Food and Drug Administration (FDA), shows how noninvasive quantitative MRI scans can identify disease accurately and reproducibly. Perspectum's second study, looks at participants in three multicenter clinical trials showing that changes in MRI biomarkers predict the biopsy changes in these patients, and thus identifies who are likely to respond to drug treatment. Specifically, a reduction of 80ms in cT1 predicted histological response.
Rezdiffra was approved by FDA in March 2024, and is the first therapeutic for patients with MASH. There is a strong pipeline of MASH drugs under development in the U.S. with anticipated approval over the next few years. Eli Lilly's tirzepatide in Metabolic dysfunction-associated steatotic liver disease (MASLD) published results in the New England Journal of Medicine in June 2024, showing a significant reduction in cT1 and liver fat over 52 weeks. Noninvasive tests (NITS) that can reliably monitor changes in liver health will reduce the need for liver biopsy -- currently used as the "gold standard" primary endpoint in MASH clinical trials. However, this new research recently reported may help pharmaceutical companies and regulatory entities have more options to consider; primarily, NITS may be used more as means to measure change in disease and monitor patient progress noninvasively.
Perspectum's CEO, Dr. Rajarshi Banerjee, commented, "Liver biopsy is not a safe or accurate way of assessing liver disease. Quantitative MRI is far safer, more scalable and already cleared by the FDA for clinical use. With more published data, the argument for replacing liver biopsy with quantitative MRI both in clinical practice and in clinical trials becomes stronger."
Naim Alkhouri, Chief Medical Officer, Chief of Transplant Hepatology, and Director of the Fatty Liver Program at Arizona Liver Health and the study's lead author said, "Establishing a threshold for cT1 reduction that can predict histologic improvement in terms of MASH resolution and fibrosis improvement will have great implications for the field and may help replace the need for liver biopsy in MASH clinical trials in the future."
Dr. Banerjee concluded that, "With the continued support of the liver disease community of stakeholders, more studies and findings such as these may see pharmaceutical companies reconsider their approach to monitoring patients in clinical trials."
About LiverMultiScan
LiverMultiScan is an established, FDA cleared 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 comprehensive picture of liver health.
About the FDA-Supported Study
This project was 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 [U01FD006880] totalling $249,940 with 100 percentage funded by FDA/HHS. 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.
About Perspectum
Perspectum, a global medical technology company with offices in the U.K., the U.S., the EU, and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic disease, multi-organ diseases 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, monitoring, 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.
For additional information, please visit: Perspectum.com and LinkedIn
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Contacts:
Nellie Wild
VP Corporate Affairs
Perspectum
nellie.wild@perspectum.com
