Target enrollment exceeded with 1009 patients randomized in the main cohort and 410 patients in the exploratory cohort
Topline results from NATiV3 projected in the second half of 2026 and, if positive, expected to be the basis for submission for regulatory approval
Daix (France), New York City (New York, United States), April 1, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases with significant unmet medical needs, today announced the completion of patient enrollment in its NATiV3 Phase 3 clinical trial with the randomization of the last patient in the main cohort. Inventiva has enrolled 1009 patients in the main cohort and 410 patients in the exploratory cohort exceeding the original target of 969 and 350, respectively.
Frederic Cren, CEO and cofounder of Inventiva, stated: “The completion of enrollment of NATiV3 marks a significant milestone in the development of lanifibranor. With topline results expected in the second half of 2026, lanifibranor could potentially be the next oral therapy approved for the treatment of patients with MASH. On behalf of the entire Inventiva team, I would like to express our deepest gratitude to the patients, investigators and staff at clinical trial sites participating in the NATiV3 trial worldwide, our partners and collaborators whose commitment has made it possible to reach this major milestone. I would also like to thank the Inventiva team who have dedicated themselves to the achievement of this critical milestone.”
Prof. Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University and co-principal investigator of NATiV3, stated: “The compelling data from the NATIVE Phase 2b trial of lanifibranor after just six months of treatment, instill strong confidence in the potential of lanifibranor to become a cornerstone therapy for patients with MASH, if approved. The unmet medical need for patients with MASH is significant, and lanifibranor’s unique mechanism of action could offer a tailored and promising potential solution, particularly for patients with advanced fibrosis and type 2 diabetes. I am eager to see the topline results and look forward to collaborating closely with Inventiva to ensure a successful NDA filing.”
Topline results of NATiV3 are expected in the second half of 2026.
Completion of enrollment in NATiV3 supports satisfaction of certain conditions related to the second tranche of approximately €116 million of the structured financing announced in October 2024 of up to €348 million, including: (i) the last patient in the NATiV3 main cohort randomized before April 30, 2025 and (ii) at the time of completion of enrollment in NATiV3, a drop-out rate of less than 30% before week 72. The second tranche of the structured financing is subject to additional conditions as set forth in the subscription agreements and there can be no guarantee that all conditions will be satisfied or that the second tranche or any further tranches of the structured financing will close on the expected timing or at all1.
About NATiV3
NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in 1009 adult patients with biopsy-proven non-cirrhotic MASH and F2/F3 stage of liver fibrosis. The effect of lanifibranor will be assessed on several histological endpoints, including MASH resolution and improvement of fibrosis of at least one stage after 72 weeks treatment. An exploratory cohort has enrolled 410 patients with MASH and fibrosis screen-failed on histology for the main NATiV3 clinical trial. Inventiva anticipates that this exploratory cohort may allow the generation of additional data using non-invasive tests and contribute to the regulatory safety database requirement to support the planned submission for regulatory approval of lanifibranor for the treatment of MASH. For more information about NATiV3, visit clinicaltrials.gov.
About lanifibranor
Lanifibranor, Inventiva’s lead product candidate, is an orally available small molecule that acts to induce antifibrotic, 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 for the treatment of MASH. 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 preclinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com
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1 See Inventiva press release October 14, 2024 and T1 Subscription Agreement, as filed with the U.S. Securities and Exchange Commission as Exhibit 99.1 to Form 6-K dated October 15, 2024, for further description and a copy of the structured financing agreement.
