The Food and Drug Administration (FDA) has granted Fast Track designation to lanifibranor (Inventiva) for the treatment of non-alcoholic steatohepatitis (NASH).
NASH is characterized by liver inflammation and cell damage due to a buildup of fat, which can eventually lead to liver fibrosis. Lanifibranor is a peroxisome proliferator-activated receptor (PPAR) agonist that works by activating 3 PPAR isoforms: PPARα, PPARδ, and PPARγ. PPAR activation is associated with decreased lipogenesis and inflammation, as well as anti-fibrotic effects; it has also been shown to reduce triglyceride levels, and increase HDL and insulin sensitization. There is currently no FDA-approved treatment for NASH.
The Company is currently investigating lanifibranor in a phase 2b NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial for the treatment of NASH. Results from the NATIVE trial are expected in the first half of 2020.
Pierre Broqua, PhD, CSO and cofounder of Inventiva, commented: “We are delighted that the FDA has granted Fast Track designation to lanifibranor for the treatment of NASH. It highlights the large and unmet medical need for this common, progressive and severe chronic liver disease, for which there is currently no approved therapy. We are convinced of the unique mechanism of action of lanifibranor, the only pan-PPAR agonist currently in development, and its potential to treat NASH patients.”
For more information visit inventivapharma.com.