Date: 2015-09-15
Type of information: Initiation of preclinical development
phase:
Announcement: results
Company: Genfit (France)
Product: diagnostic method used to identify NASH patients that should be treated with elafibranor (GFT505)
Action mechanism:
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic area: Liver diseases - Hepatic diseases - Diagnostic
Country:
Trial details:
Latest
news: * On September 15, 2015, Genfit announced the development of a new reliable and non-invasive diagnostic method, based on the measurement of a novel type of blood biomarker: small non-coding RNA, or miRNA. The algorithm developed enables the identification of NASH patients that should be treated with elafibranor (GFT505) or any other appropriate drug.
The company has launched an R&D initiative in the field of NASH diagnosis biomarkers based on its expertise in transcriptomics applied to small circulating non-coding RNAs, in particular miRNA. Genfit has constituted a large bank of plasma samples from NASH patients with a liver biopsy. This patient cohort is extremely well-characterized (complete anthropometric and biochemical data, centralized biopsy reading), and covers a wide spectrum of NASH disease activity and severity. After developing and validating a reliable method for the systematic measurement of different miRNAs in the plasma, Genfit has introduced these
measurements into the data set and challenged their diagnostic values versus over 70 variables using two independent biostatistical approaches. Two methods were used to generate thousands of cohorts from the initial patient population in order to mimic real-life NASH variability and assure the translatability of the results to the global NAFLD/NASH population. These parallel approaches independently identified the same two specific miRNA species within the top 3 most powerful diagnostic markers of NASH. The two resulting algorithms combine the identified miRNAs and known markers of liver damage. A comparative study demonstrates that these algorithms are more powerful than existing scoring systems for the identification of NASH patients that deserve to be treated. New patent applications have been filed for the use of the technologies developed by Genfit for the diagnosis of NASH. A new proprietary diagnostic tool will be used in the Phase 3 trial for elafibranor.
