Inventiva selected to present the results of its NATIVE Phase IIb clinical trial with lanifibranor in NASH during a plenary session at The Liver Meeting Digital Experience 2020
Daix (France), October 5, 2020 – Inventiva (Euronext Paris and 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 that it has been selected to present the results from its 24-week Phase IIb trial evaluating lanifibranor for the treatment of NASH in an oral plenary presentation at The Liver Meeting Digital Experience 2020, which will be held virtually November 13-16, 2020.
Entitled "The panPPAR agonist lanifibranor induces both resolution of NASH and regression of fibrosis after 24 weeks of treatment in non-cirrhotic NASH: results of the NATIVE Phase IIb trial", the abstract will be presented by Prof. Sven Francque, M.D., Ph.D. from Antwerp University Hospital and co-principal investigator of the trial.
During this trial, lanifibranor met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT1) and Per Protocol populations (PP2). In particular, lanifibranor achieved statistically significant effects on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the US Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking accelerated approval during future Phase III clinical development.
Oral presentation details
Publication Number: 0012
Session Title: Plenary: Clinical and Outcomes Discoveries
Presentation Type: Oral presentation, Plenary Session
Presenting Author: Sven Francque, M.D., Ph.D. from Antwerp University Hospital
Session Broadcast Date and Time: Sunday, November 15, 2020, 9:00 AM (Eastern Time)
Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.