Date: 2016-09-20
Type of information: Initiation of development program
phase:
Announcement: initiation of development program
Company: Genfit (France)
Product: noninvasive NASH diagnostic based on miRNAs
Action
mechanism: microRNA (miRNA). 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. Their differential expression in disease states and their stability in biological fluids make them ideal candidates in the search of circulating biomarkers of NASH.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic area: Metabolic diseases - Liver diseases - Hepatic diseases
Country:
Trial
details: * On September 20, 2016, Genfit 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. As part of a newly launched qualification program dedicated to proprietary miRNAs and associated algorithms for a non-invasive diagnostic of NASH, Genfit has signed 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. The purpose of this approach is to facilitate the identification of NASH patients to be
treated.
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.
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