Benzinga | Jan 5, 2021 04:01PM EST

Inventiva Announces Design Of Phase III Clinical Trial With lanifibranor In NASH

* A single global Phase III clinical trial evaluating two doses of lanifibranor (800mg and 1200mg once daily) versus placebo is intended to support U.S. New Drug Application (NDA) / EU marketing authorization

* Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on 72-week histology analysis in approximately 900 patients

* Use of primary composite endpoint combining NASH resolution and fibrosis improvement

* Inventiva confirms planned initiation of pivotal Phase III clinical trial in H1 2021

Daix (France), January 5, 2021 -- Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced the details of the Phase III clinical trial with its lead drug candidate lanifibranor in NASH following the end-of-phase II meeting with the U.S. Food and Drug Administration (FDA) and the receipt of the Scientific Advice letter from the European Medicines Agency (EMA). The Phase III trial design and clinical strategy have been discussed with both regulatory authorities and the following key points can be confirmed:



* Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on a 72-week histology analysis -- Inventiva will seek to obtain accelerated approval in the U.S. and conditional approval in the EU for lanifibranor based on a pre-specified histology analysis in approximately 900 patients after 72 weeks establishing a positive benefit-risk ratio. Use of a primary composite endpoint combining NASH resolution and fibrosis improvement -- The primary composite endpoint of patients having both NASH resolution and fibrosis improvement of at least one stage will be used for the 72-week histology analysis. The endpoint is designed to predict a significant improvement of prognostic risk and, if met, may support a label for the treatment of NASH and the improvement in liver fibrosis in adult non-cirrhotic NASH patients. During Inventiva's NATIVE Phase IIb clinical trial, this endpoint was met with statistical significance, including in NASH patients with F2/F3 fibrosis, the patient population that will be included in the Phase III trial, as well as in NASH patients with type two diabetes (TD2M). Endpoints of NASH resolution and no worsening of fibrosis, and improvement of fibrosis with no worsening of NASH will be included as key secondary endpoints. Additional supportive histologic endpoints, non-invasive markers of liver fibrosis and steatohepatitis as well as effects on lipids and insulin resistance will also be evaluated.