› Launch of a large scale qualification program for a proprietary non-invasive NASH diagnostic based on miRNAs, with a first collaboration agreement signed with Pr. Sven Francque from the Antwerp University Hospital
› Validation, with the independent cohort of Pr. Francque, of miRNAs discovered in H2 2015 using the GOLDEN-505 cohort
› Discovery, at the same time, of a new set of highly predictive miRNAs (detailed results will be presented by the end of 2016)
Lille (France), Cambridge (Massachusetts, United States), September 20, 2016 – GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced the launch of a large scale validation and qualification program for non-invasive NASH diagnostic and longitudinal patient follow-up based on proprietary miRNAs and algorithms.
MicroRNAs (miRNAs) represent a class of small non-coding RNAs whose principal role is to control essential biological functions by modulating expression of target genes. They are emerging players in the understanding of the development of chronic diseases. Their differential expression in disease states and their stability in biological fluids make them ideal candidates in the search of circulating biomarkers of NASH.
As part of a newly launched qualification program dedicated to proprietary miRNAs and associated algorithms for a non-invasive diagnostic of NASH, GENFIT announced the signature of a long-term collaboration with Pr. Sven Francque, MD, PhD, Professor of Hepatology, Head of the Department of Gastroenterology and Hepatology, Antwerp University Hospital, Belgium.
This first agreement is the initial milestone of a large program that will involve multiple expert hepatology clinics across Europe and in the USA. Ultimately, the level of circulating miRNAs will be measured in thousands of NAFLD patients (NASH and non-NASH), and their performance in the diagnosis of liver lesions – as well as their evolution – will be qualified in different medical and operational contexts.
Under the agreement with the Antwerp University Hospital, GENFIT has access to a new cohort of obese patients with associated liver biopsies and blood samples. First analyses have validated the predictive value of miRNAs previously identified by GENFIT as biomarkers of NASH.
In parallel, GENFIT has identified a new set of miRNAs with high predictive value for identification of NASH patients to be treated. Validation of these new miRNAs in the Antwerp cohort should be obtained by the end of 2016.
Together, these milestones demonstrate the ability of GENFIT to develop a non-invasive diagnostic test. The ultimate purpose of this approach is to facilitate the identification of NASH patients to be treated. From a commercial perspective, these discoveries are intended to unlock the NASH market potential.
About the Antwerp University Hospital cohort
The Antwerp University cohort includes obese patients (NASH and non-NASH). Some patients have undergone bariatric surgery (stomach and/or intestines) in order to limit food absorption and consequently diminish daily caloric intake. For all patients, a liver biopsy was made and blood samples were collected and stored. For some patients, a second liver biopsy and new blood tests were made a year later, in order to evaluate changes in liver histology.
Under the agreement, GENFIT will not only have access to samples for miRNA quantification, but also to all patient-related information: anthropometry, medical history, clinical and biochemical exams, histologic scores for NASH (steatosis, inflammation, ballooning) and fibrosis, at the time of surgery as well as a year later.
As required by regulations, all patients have given prior consent, and all information provided to GENFIT is anonymized.
