AMRA, BioTelemetry partner on NASH/NAFLD clinical trials
AMRA, the international leader in body composition analysis, and BioTelemetry Research (BTR), a global imaging and cardiac core lab, announced the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas.
In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining muscle or fat mass. However, until now they have been constrained by prohibitive costs and insufficiently precise outcomes.
AMRA’s body composition analysis service has introduced a new and better paradigm where rapid, six-minute whole body MRI scans are transformed into precise, three dimensional-volumetric fat and muscle measurements. This standardized, automated method eliminates reader variability and reduces processing costs. With those advancements, BioTelemetry Research is able to provide clinical trial sponsors with new, high-value information to about their drug compounds’ efficacy and mechanisms of action, including the identification of previously undetectable changes within and beyond the liver.
Tommy Johansson, Chief Executive Officer of AMRA, commented, “BioTelemetry Research is the ideal core lab to help us deliver this enhanced value to clinical trial sponsors. They bring unique expertise managing the protocol complexity, site training intensity and equipment variability that are common to non-standard-of-care MRI trials.”
He continued, “BioTelemetry was a leading pioneer in proton density fat fraction (PDFF) analysis, and have analysed more liver fat cases, from more sites, in more regions than any other group in industry. I am excited to see where our partnership will take us.”
BioTelemetry Research President and General Manager, Scott Satin, added, “By employing AMRA’s automated analysis, we are now able to efficiently provide more actionable data to our pharmaceutical partners. Ordinarily, a whole body MRI scan takes 10 to 15 minutes and produces hundreds of images. Prior to AMRA, such analyses were infeasible in clinical trials largely because of the time needed to label fat and muscle tissues within every image. With those challenges eliminated, we can now help sponsors assess the effects of their treatments more quickly and completely.”
Through collaboration with leading universities such as the University of California, San Diego (UCSD) and the University of Westminster, London, AMRA’s technique has been proven to enable market-leading accuracy and precision when measuring fat depots and muscle volumes, as well as the fat infiltration of muscles and in organs. BioTelemetry has the scientific expertise and operational experience to apply this technique successfully in global clinical trials. Together, the alliance is committed to accelerate the prevention and treatment of diseases such as NAFLD and obesity.