Benzinga | Sep 8, 2021 04:02PM EDT

Inventiva Announces The Initiation Of Its Pivotal Phase III Clinical Trial Evaluating Lanifibranor In NASH

* Activation of first clinical sites and start of patient screening

* The two-part NATiV3 Phase III clinical trial will evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis

* The primary endpoint of the trial's part 1 will evaluate the response to the treatment defined by both resolution of NASH and fibrosis improvement of at least one stage

* Publication of topline results of part 1 of the trial is expected for H2 2024

* Based on the results of part 1 of the NATiV3 trial, Inventiva intends to seek U.S. accelerated approval and EU conditional approval for lanifibranor