Inventiva (IVA) Leerink Global Healthcare Conference 2026 summary

Program overview and clinical development

• Lead asset lanifibranor is a pan-PPAR agonist in phase 3 trials for MASH, with pivotal data expected in the second half of 2024 and a focus on F2/F3 patients.

• Phase 3 NATiV3 trial enrolled about 1,000 patients, focusing on F2/F3 fibrosis, with a higher proportion of diabetics and advanced disease compared to earlier studies.

• GLP-1 therapies, including semaglutide, are allowed as background medications in NATiV3, reflecting real-world practice.

• Stratification in NATiV3 is by diabetes status and fibrosis stage, not by specific concomitant medications.

• An exploratory cohort includes F1–F4 patients, providing safety data and informing future outcome studies, especially in F4/cirrhotic populations.

Efficacy and safety insights

• Phase 2b data showed 26% NASH resolution and 18% fibrosis improvement at six months; expectations are for a deepening effect at 18 months in phase 3.

• The primary endpoint in phase 3 is a composite histology measure, with confidence in replicating phase 2b results due to robust methodology and similar patient populations.

• Non-invasive biomarkers (Pro-C3, MRI-PDFF) showed promising trends, with expectations for stronger signals over longer treatment duration.

• Safety profile is favorable compared to older PPARs, with muted PPAR-gamma effects; weight gain and fluid retention are present but less pronounced than with pioglitazone.

• Dropout rates in NATiV3 are below 30%, meeting investor milestones and suggesting good tolerability and patient persistence.

Market positioning and commercial strategy

• Lanifibranor is positioned as best-in-class oral therapy for F2/F3 MASH, especially in diabetic and advanced fibrosis populations.

• Market segmentation targets approximately 375,000 F2/F3 patients under care, with initial focus on F3 diabetics and potential expansion to F2 non-diabetics if efficacy is strong.

• Commercialization plans follow the model established by recent mid-size biotech launches, with a targeted sales force and potential for independent launch.

• Exclusivity for lanifibranor extends to 2041 based on polymorph patents, despite composition of matter expiring in 2026.

• Outcome studies in F4/cirrhotic populations are planned to confirm and expand indications, aligning with regulatory expectations and leveraging exploratory cohort data.