Lanifibranor's Potential and Mechanism - Lanifibranor is a promising oral small molecule designed to treat MASH by targeting intrahepatic fibrosis progression and extrahepatic manifestations, delivering anti-inflammatory & metabolic benefits[13] - Lanifibranor is a differentiated pan-PPAR agonist with moderate and well-balanced activity on the three PPAR isoforms[34] - Phase 2b data showed an 18% improvement in fibrosis with no worsening of MASH vs placebo at 6 months (42% vs 24%, p=001) and improved cardiovascular, glycemic, and metabolic markers[14] - Lanifibranor observed to induce a decrease in key serum biomarkers consistent with histologic endpoints, with a 139% decrease in Pro-C3 (p=0005) and a 411% decrease in CK18-M30 (p<0001) compared to placebo[81] Market and Clinical Trial Landscape - The US has approximately 19 million diagnosed MASH patients[9] - Analysis shows significantly more than ~315K MASH patients are under treater care[10] - 85% of specialists in the US described the greatest unmet needs as lack of effective, liver directed therapies[12] - In the Phase 2b NATIVE trial, 24% of patients on lanifibranor 1200mg achieved resolution of MASH and improvement of fibrosis, compared to 3% on placebo[76] - NATiV3 is fully recruited with 1009 patients in the main cohort and 410 in the exploratory cohort[95] Inventiva's Strategy and Timeline - Inventiva raised $411 million in a successful PIPE financing in October 2024[7] - Inventiva aims to re-define MASH treatment with lanifibranor, with targeted launch in 2028[16, 17] - Topline results for NATiV3 are expected in H2 2026[7, 17]