We are actively committed to research for novel diagnostic tools for NASH, whether it be new blood markers or new scoring systems.
A strong expertise has been developed in a wide range of techniques such as proteomics, peptidomics, the purification, characterization and quantification of microvesicles or circulating nucleic acids, as well as in bioinformatics.
Our ready access to both healthy and diseased samples of human or animal origin enables us to identify new markers, for which we can rapidly initiate clinical validation.
The close collaboration with a company specialized in the development and marketing of novel In Vitro Diagnostic (IVD) kits enables us to benefit from complementary know-how that is ideal for the rapid development of these programs.
Identification of biomarkers for the diagnosis of NASH
Our research program uses “omics” approaches including transcriptomics applied to small circulating RNA, and benefits from the high quality samples and clinical data originating from the Phase 2b clinical trial currently in progress with Elafibranor (GFT505), our drug candidate for the treatment of NASH.
The NASH databank represents a precious analytical tool for this data.
Our program in the field of NASH diagnostics has two major objectives:
- Discover new biomarkers for a better diagnosis of this disease, and particularly new scores that enable the discrimination of NASH patients from NAFLD (“fatty liver”) patients. This approach will result in better patient identification and stratification.
- Find new biomarkers to identify those NASH patients that respond best to Elafibranor treatment. This approach will enable the discovery of a companion tool for Elafibranor.
Since we believe that the discovery of a unique marker for NASH is not realistic, with the help of our bioinformatics department we endeavor to develop new algorithms or scores that combine both known biomarkers and new biomarkers identified through our research program.
The program benefits from two major advantages :
- The human blood samples that we collect during the Phase 2b NASH trial with Elafibranor. These samples from NASH patients whose disease is histologically controlled at the beginning and after one year of treatment, are analyzed for all the parameters known to be relevant to NASH diagnosis (liver enzymes, lipids, inflammatory markers, non-invasive fibrosis and steatosis markers, etc.). They are also studied with our range of “omics” techniques; in particular the small circulating RNA content is characterized.
- The NASH databank that gathers, organizes, and analyzes all the data from the NASH Program, thus allowing our bioinformatics teams to define new biomarker scores
Biomarkers for improved patient care
Given that today, a histological examination of the liver is required to diagnose NASH and determine the hepatic fibrosis stage, the development of new biomarkers or new algorithms based on existing or novel markers is a need that is recognized by health authorities, and that will lead to improved patient care.
At GENFIT, we are strongly implicated in the search for novel NASH biomarkers that aim to replace the current invasive procedure. Our approach combines the identification of novel blood markers and the calculation of algorithms of several biological measurements in order to obtain a score.
This work benefits from the technological advances that we have made throughout our research of prediabetes/diabetes biomarkers ; tests for the measurement of some of them are currently being developed in collaboration with a specialized company.