Imagine if an ultrasound could be used as a quantitative tool to measure fat in the liver and detect non-alcoholic fatty liver disease (NAFLD). What seems imaginative is close to becoming reality at ENDRA Life Sciences.
The Michigan-based company is developing TAEUS, Thermo-Acoustic Enhanced UltraSound that could become a revolutionary diagnostics tool for doctors. TAEUS is a non-invasive tool that precisely measures the amount of fat in the liver at point of care. Chief Executive Officer Francois Michelon told BioSpace in an interview that the company is on the very of providing an effective tool that will provide a pathway for treatment for a large patient population.
“There are multiple therapies in the pipeline to treat NAFLD and NASH, but there are no practical diagnostics tools and Endra is trying to address this,” Michelon told BioSpace.
NAFLD is a condition in which excess fat is stored in the liver and is not caused by heavy alcohol use. NAFLD is one of the most common causes of liver disease in the United States, and a precursor to NASH (nonalcoholic steatohepatitis). NASH is estimated to affect more than 16 million people in the U.S. alone. If untreated, NASH patients face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation Also, they are at a significantly higher risk of liver-related mortality. Current treatment standards for NASH are lifestyle changes, including diet, weight loss and exercise.
This has been a pivotal time in the development of NASH and NAFLD treatments. France-based GenFit has its asset elafibranor in Phase III development for NASH and is also developing its own in vitro diagnostic test for NASH based on a blood sample. Intermediate results are anticipated for elafibranor before the end of the year. In addition to GenFit, Gilead Sciences and Intercept also have NASH-aimed therapies in late-stage development. Intercept posted positive Phase III results for its obeticholic acid asset treating liver fibrosis in NASH patients. Intercept is planning to file a New Drug Application for this asset this year. Gilead’s NASH drug selonsertib stumbled earlier this year as it failed to meet its primary endpoint of treating compensated cirrhosis in NASH.
What Endra is hoping to achieve, Michelon said, is to become the “blood pressure cuff” for liver disease. Endra’s TAEUS provides an analysis for fat in the liver and it also allows medical professionals to see tissue temperature change during surgical procedures, flow of liquid in tissues. As companies look to develop treatment, Michelon said this tool will become a substantial tool. Fat in the liver is a core problem for NAFLD and NASH, he said. If the amount of fat can be measured both accurately and safely and used in conjunction with new therapies that are potentially coming online in the next year or so, they will be one step closer to addressing a critical need in health care. Michelon said they estimate that about 1 billion people on the planet have NAFLD and NASH and the problem is growing. What’s more, Michelon said many people have no idea they are affected with the disease.
“Obesity and diabetes are not going away… all the core drivers for the liver to over-accumulate fat are not going away,” Michelon said.
Currently, the only ways to measure fat in the liver are either through a costly MRI, which many people do not have access to, or through an invasive liver biopsy, which Michelon said is not only “painful and bloody,” but also “risky.”
Michelon said the TAEUS system can have a market price of about $50,000, which when compared to the million dollar price of an MRI, is pretty affordable. What’s more, there are an estimated 9,000 sites in the U.S. that perform ultrasounds, which means there is already an established clinical practice of using ultrasounds for gastric work, he added. Michelon said the goal is to have their system pass all the regulatory hurdles and be available for commercial use sometime in 2020. If a launch does happen, Michelon speculated it would be slow as they try to build a market for the system.