Biotech and pharma companies shared their mid- to late-stage fatty liver disease data earlier this month at the European Association for the Study of the Liver conference, and now the first-ever approval addressing this growing health burden appears to be peeking over the horizon.
The likes of Shire, Gilead Sciences, Intercept Pharmaceuticals and Genfit, among many, many others, are looking to find a way into this potentially major market to cut the dangerous fat that can build up in, predominately, obese and diabetes patients’ livers, and to cut down its harmful effects, which can lead to scarring, cirrhosis and liver failure.
It’s not been an easy path: All the main players have been beset by setbacks, and some, such as Gilead, have seen some pretty big flops and are now attempting a pivot toward combination therapies, with others still hoping for single therapy activity to be enough.
One of the big issues is that, being a new area, just how you target this disease and via what biomarkers is still unclear. Bioclinica, a biopharma services company, is launching a new service aimed at using medical imaging in tests designed to push on with trial work in this area.
It’s a key aspect: One of the main and most accurate ways of assessing how much fat there is in the liver and whether it is being reduced is by inserting a needle into the organ. As this is a largely “silent” disease, i.e., patients typically don’t have any symptoms until very late, when their livers may be beyond repair, this can be a very invasive intervention that comes with its own risks.
It’s also one of the big reasons some analysts don’t see nonalcoholic steatohepatitis (NASH) drugs as being quite worth the $40 billion a year at peak sales the more bullish observers do, given the reliance on liver biopsies. Bioclinica hopes its new service will help its clients develop therapeutics using medical imaging and other biomarkers in clinical trials rather than a big needle.
“We’ve assembled a world-class team with a deep understanding of this disease space and the scientific, medical and regulatory intricacies of medical imaging endpoints for NAFLD and NASH trials to accelerate clinical development of effective treatments approved by international regulators,” explained Bioclinica’s president and CEO David Herron.
Its scientific director Mark Tengowski, Ph.D., said: “We’re currently working with regulators and sponsors to successfully apply medical imaging as a reliable and non-invasive method of assessing liver fat and stiffness parameters. Our collective objective is to significantly reduce or replace the reliance on liver biopsies with non-invasive imaging methods to assess therapeutic response.
“High-quality quantitative liver imaging is no easy task. Bioclinica MRI scientists and technologists work closely with the imaging facilities to qualify their equipment and train the staff on proper acquisition techniques,” Tengowski went on, adding: “These efforts combined with ongoing quality control ensure accurate, consistent, and reliable endpoints.”
Bioclinica says, in practical terms, this will see it provide sponsors “end-to-end NAFLD/NASH clinical trial support, beginning early in the protocol design process and extending through to regulatory submission.”
These services include infrastructure to submit, manage, analyze, report and transfer trial medical imaging data compliant with global data privacy and regulatory requirements using Bioclinica’s SMART suite.