NATIVE Phase III Trial

A Phase III clinical trial, NATiV3 (NASH lanifibranor Phase 3 trial), has been initiated following the publication in June 2020 of positive results from the NATIVE Phase IIb clinical trial with lanifibranor in patients with NASH and the designation of lanifibranor as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in October 2020.

The clinical results of the Phase IIb, NATIVE, published in The New England Journal of Medicine, show that after 6 months of treatment lanifibranor achieved to resolve NASH and improve liver fibrosis.

NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. The trial takes place in approximately 25 countries and in more than 350 clinical sites.

NATiV3 will recruit 900 patients and will last 72 weeks. The effect of lanifibranor will be assessed on several histological endpoints, including NASH resolution and improvement of fibrosis of at least one stage.

An exploratory cohort will enrol patients screen-failed for the main NATiV3 study allowing to generate additional data using non-invasive tests and will contribute to the regulatory safety database necessary for a New Drug Application (NDA) submission.

Positive results will allow Inventiva to request accelerated approval to the Food and Drug Administration (FDA) and conditional approval to the European Medicines Agency (EMA) of lanifibranor for the treatment of NASH.

Topline results of NATiV3 are expected for the second half of 2025. For more information about NATiV3, visit clinicaltrials.gov.