Nonalcoholic steatohepatitis (NASH)
Once installed, the disease is accompanied with a high risk of cirrhosis, a state where the liver functions are altered and can progress to liver insufficiency. Thereafter, the NASH often progresses to liver cancer.
To face this challenge, Genfit focuses on bringing therapeutic solutions to combat the major health concerns of NASH. At Genfit, we are committed to ensuring that our drug candidate Elafibranor (GFT505) becomes a first-in-line medicine in its field, thus bringing a therapeutic solution to patients who currently have no treatment options.
The treatment of NASH is a major therapeutic need
According to the leading hepatologists, NASH is considered a « ticking time bomb » and the regulatory authorities (FDA and EMA) have supported the needs for the discovery of efficient treatments for this disease.
The therapeutic needs are tremendous worldwide as the number of NASH cases is constantly expanding, together with the diabetes and obesity epidemic. Hence, in the United States, the NASH prevalence is estimated over 12% the adult population. For the diabetic population, the number rises up to 22%. It is noteworthy that between 15 to 25% of NASH patients will develop cirrhosis.
There are numerous risk factors and predictors of NASH: age, obesity and BMI (Body Mass Index), insulin sensitivity, dyslipidemia, hypertension and increase of liver enzymes. In turn, patients with NASH have increased risks for myocardial infarction, stroke or peripheral vascular accident.
Hepatologists have no treatment options for their patients
The ideal drug candidate will require essential pharmacological activities aimed to improve insulin sensitivity, glucose metabolism, and dyslipidemia (with a reduction of triglycerides and LDL-cholesterol; increase of HDL-cholesterol). Moreover, in order to reduce the steatosis and circulating liver enzymes and to halt the development of fibrosis, the drug candidate should also confer anti-inflammatory and antioxidant properties.
This ideal drug profile has been demonstrated for Elafibranor during the course of numerous preclinical and clinical studies (phase I, phase II), and Genfit is pursuing its efforts to establish Elafibranor as a pioneer drug in the NASH field.