Inventiva Publishes Predictive Biomarker Data For Lanifibranor In MASH And Fibrosis Patients In Leading Journal

Inventiva is a clinical-stage biopharmaceutical company that develops oral small-molecule therapies for treating metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases without treatment options. The company has published an analysis in Clinical Gastroenterology and Hepatology showcasing new non-invasive biomarker signatures capable of predicting histological response to its lead candidate lanifibranor, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. This development could mark a significant step forward in personalising treatment approaches for MASH.

Pr. Jérôme Boursier, Head of Department Hepato-gastroenterology and digestive oncology at the University Hospital Centre of Angers, stated: "Our collaboration with Inventiva has been instrumental in addressing the critical need for reliable non-invasive biomarkers in MASH. With the effects of lanifibranor on histological endpoints observed in the NATIVE Phase 2b trial and our encouraging biomarker dataset, we are optimistic about developing robust composite biomarker scores which could predict treatment response and therefore the identification of patients most likely to respond to treatment with lanifibranor. In our analyses, the biomarker signatures outperformed the current scores available in predicting the response to lanifibranor. We look forward to continuing our efforts to refine these signatures further and ultimately transforming patient management in chronic liver disease." 

The study evaluated 71 biomarkers, including laboratory parameters and diagnostic scores, in patients from the Phase 2b NATIVE trial. The focus was on identifying signatures that could predict three distinct treatment outcomes: MASH resolution with fibrosis improvement, MASH resolution without worsening fibrosis, and fibrosis improvement without worsening MASH. These were categorised into E1, E2, and E3 scores, each consisting of baseline and on-treatment biomarker changes linked to metabolic, apoptotic, and fibrotic processes.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “Our collaboration with Professor Boursier and his team has enabled us to develop robust biomarker signatures that significantly enhance our ability to predict treatment response for patients treated with lanifibranor using a combination of serum-based biomarkers obtained in clinical practice. These signatures were developed and validated using NATIVE, and we aim to further our analysis with the data from our Phase 3 clinical trial. The analysis further strengthens our confidence in the potential for lanifibranor to become a liver-targeted backbone treatment for MASH.”

These non-invasive biomarker scores showed strong predictive accuracy with AUROC values around 0.8, making them promising tools for identifying which patients may benefit most from lanifibranor. This research supports the shift toward precision medicine in liver disease treatment and could reduce the need for invasive biopsies in managing MASH.