Inventiva announces positive DMC recommendation for Phase III NATiV3 trial with lanifibranor in MASH/NASH patients

On May 16, 2024, Inventiva, a clinical-stage biopharmaceutical company listed on Euronext Paris and Nasdaq, announced a positive recommendation from the Data Monitoring Committee (DMC) to continue the NATiV3 Phase III clinical trial for lanifibranor in patients with metabolic dysfunction-associated steatohepatitis (MASH) or non-alcoholic steatohepatitis (NASH). The trial will proceed without any changes to the existing protocol based on a thorough review of safety data.

The DMC, comprised of independent experts, reviewed unblinded safety data from over 900 patients enrolled in both the main and exploratory cohorts. The main cohort includes patients with MASH/NASH and fibrosis stages F2 and F3, while the exploratory cohort includes patients with fibrosis stages F1 through F4 who are not eligible for the main cohort. The review included data from more than 360 patients treated for over 48 weeks and 80 patients treated for more than 72 weeks. The DMC's recommendation to continue the trial without modifications underscores the favorable safety profile of lanifibranor.

Lanifibranor is Inventiva’s lead product candidate, an orally-administered small molecule designed to induce anti-fibrotic, anti-inflammatory, and beneficial metabolic and vascular changes by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms. Unlike other PPAR agonists that target only one or two isoforms, lanifibranor is a pan-PPAR agonist, activating PPARα, PPARδ, and partially PPARγ. This balanced activation contributes to its favorable safety and tolerability observed in clinical and pre-clinical studies. The FDA has granted lanifibranor Breakthrough Therapy and Fast Track designations for MASH/NASH treatment.

The NATiV3 trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of lanifibranor at dosages of 800mg and 1200mg daily in adult patients with biopsy-confirmed non-cirrhotic MASH/NASH and F2/F3 stage liver fibrosis. The trial spans 24 countries and more than 400 clinical sites, aiming to recruit approximately 900 patients for treatment over 72 weeks. The trial will evaluate lanifibranor’s impact on several histological endpoints, such as NASH resolution and fibrosis stage improvement.

Additionally, an exploratory cohort is expected to enroll around 200 patients with MASH/NASH and fibrosis who do not meet the criteria for the main trial. This cohort aims to generate additional data through non-invasive tests, contributing to the regulatory safety database. This data will support potential accelerated approval submissions to the FDA and conditional approval applications to the European Medicines Agency (EMA) for lanifibranor in NASH treatment.

Inventiva, headquartered in Daix, France, specializes in developing oral small molecule therapies for MASH/NASH and other diseases with substantial unmet medical needs. The company boasts extensive expertise in targeting nuclear receptors, transcription factors, and epigenetic modulation. Besides lanifibranor, Inventiva’s pipeline includes odiparcil for treating adult MPS VI patients, although clinical efforts for this candidate have been suspended to focus resources on lanifibranor. The company is also advancing preclinical programs and exploring additional development opportunities.

Inventiva's scientific team comprises approximately 90 experts in various fields including biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. The company owns a library of around 240,000 pharmacologically relevant molecules, 60% of which are proprietary, and operates its own research and development facility. 

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