SOPHIA ANTIPOLIS, France—Median Technologies has signed a research collaboration agreement with the University of California, San Diego (UC San Diego) aimed at conducting a study on liver fibrosis severity in non-alcoholic steatohepatitis (NASH) patients while enabling Median to quantify the ability of iBiopsy’s learning algorithms to discriminate between early and advanced fibrosis grade. Advanced NASH patients are at risk of progressing to cirrhosis and liver cancer.
Median estimates that NASH is affecting 1.5 to 6.45 percent of the global population. There is currently no cure for advanced stages of the disease, but diagnosing the disease early can save patients lives as NASH, in its early stages, is reversible through changes in eating habits and lifestyle.
The study is led by principal investigator Dr. Kathryn Fowler, a diagnostic radiologist and professor of radiology at UC San Diego (UCSD), who last year conducted a study retrospectively on a cohort of more than 300 patients. Median expects to confirm the promising results on the NASH Clinical Development Plan, which were released in November 2020. The first results of the latest Median-UC San Diego study are currently expected in the first quarter of 2022.
“Non-alcoholic fatty liver disease (NAFLD) is an umbrella term that encompasses the entire spectrum of fatty liver disease, from isolated steatosis to NASH,” says Fredrik Brag, CEO of Median Technologies.
NASH prevalence is expected to grow by 63 percent between 2015 and 2030. According to the National Health and Nutrition Examination Survey, up to 10.3 percent of patients with NAFLD have advanced fibrosis (F3 bridging fibrosis and F4 cirrhosis).
“In its early stages, NASH remains reversible via diet and lifestyle changes, whereas, in its end stages, liver transplantation may be a patient’s only treatment option,” Brag notes. “Liver fibrosis grade is key in NASH prognosis, as there is clinical interest in establishing reliable and non-invasive tests to distinguish accurately patients with early versus advanced fibrosis.”
The iBiopsy technology “aims at diagnosing patients with early fibrosis when the damage is limited and reversible, and treating fibrosis in its early stages can greatly improve the chance of making a full recovery,” he adds.
“There are four grades of fibrosis, with the advanced stage (F3 bridging fibrosis - local or extensive; F4 Cirrhosis - forms nodules),” Brag explains. “The progression of fibrosis in patients with NASH is variable. On average, 40 percent have progression of fibrosis over a mean period of three to six years. Although the change of fibrosis stage is slow (being about 0.02 stages overall per year), some individuals have a relatively rapid progression (more than 0.5 stages per year).”
The study is conducted retrospectively on the past 10 years of biopsy-diagnosed NASH patients.
“Median will validate preliminary results based on the existing images associated with biopsy and other clinical data,” Brag reports. “Data will come from UCSD only. UCSD and Median are currently finalizing the study protocol. With positive results, we will request a meeting with the FDA to discuss the regulatory approval pathway.”
On Nov. 24, Median reported that iBiopsy showed promising results on a preliminary study to identify the severity of the disease in patients with NASH.
According to the World Health Organization (WHO), NAFLD affects 25 percent of the global population. For 20 percent of patients, NAFLD leads to NASH.
Hepatic biopsy is a traditional method used to measure hepatic fibrosis severity. However, due to its invasiveness and sampling errors related to small sample size, as well as spatial variation in degree of fibrosis, hepatic biopsy is not used as first indication for diagnostic purposes. In routine clinical practice, the assessment of the absence of advanced fibrosis of the liver is done by non-invasive tests such as blood tests and hepatic elastography, according to Median. However, the biopsy is essential for the diagnosis of advanced NASH. And in clinical routine, morphologic signs on MRI alone are unreliable and insufficient to detect even significant liver fibrosis.
Preliminary results showed that the iBiopsy non-invasive fibrosis biomarker for NASH could allow for the discrimination between early and advanced fibrosis based on standard imaging modalities.
“These initial results are exciting and show once again the relevance of our iBiopsy approach and the tremendous possibilities of AI-based technologies to extract hidden information from standard medical images and generate non-invasive biomarkers,” Brag commented.
Median’s iBiopsy development program is supported by the European Investment Bank (EIB) through a financial loan of €35 million under the Juncker Plan, the European Fund for Strategic Investments.