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 completed enrollment in April 2024, enrolling about 1,000 patients for 18 months, compared to 247 in the earlier phase 2b trial.

• Patient population in phase 3 is enriched for diabetics and F3 fibrosis, reflecting real-world disease trends.

• GLP-1 therapies, including semaglutide, are allowed as background medications in NATiV3, with stratification by diabetes status and fibrosis stage.

• An exploratory cohort of 410 patients, including F4, is being studied for safety and to inform future outcomes studies.

Efficacy and safety insights

• Phase 2b data showed 26% NASH resolution and 18% fibrosis improvement at 6 months; expectations are for a deepening effect at 18 months in phase 3.

• Lanifibranor is designed to avoid the safety issues of earlier PPARs, with a novel scaffold and blunted PPAR-gamma effects, resulting in less weight gain and fluid retention.

• Blinded interim analyses in NATiV3 indicated dropout rates below 30%, meeting investor milestones and suggesting good tolerability.

• Non-invasive biomarkers (Pro-C3, MRI-PDFF) and imaging data support histology findings, with expectations for stronger signals at 18 months.

• Weight gain is generally muted, with about half of patients gaining no weight and only 10% reporting it as an adverse event in phase 2.

Regulatory and commercial strategy

• Accelerated approval is being pursued for F2/F3, with a confirmatory outcomes study planned in F4/portal hypertension patients.

• Regulatory alignment with FDA is ongoing, with plans to initiate the outcomes trial by NDA filing and leverage safety data from the exploratory cohort.

• Commercialization plans include building a targeted sales force for GI and hepatology, following the model established by peers, with the ability to launch independently.

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

• Positive outcomes data from competitors in F4 could validate the surrogate endpoints and benefit the entire field.