Inventiva, a biopharmaceutical company focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH), announced a positive recommendation from the Data Monitoring Committee (DMC) for its Phase 3 NATiV3 clinical trial evaluating lanifibranor in MASH patients. The DMC recommended continuing the trial without any modifications to the current protocol, based on a review of safety data from over 1000 patients.
DMC Review and Safety Data
The independent DMC conducted its review using unblinded safety data from patients in both the main and exploratory cohorts of the NATiV3 trial. The data included over 800 patients treated for more than 24 weeks and 177 patients treated for more than 72 weeks. This review supports the ongoing assessment of lanifibranor's safety and tolerability profile, which remains blinded to Inventiva.
Lanifibranor: A Pan-PPAR Agonist
Lanifibranor is an orally available small molecule designed to activate all three peroxisome proliferator-activated receptor (PPAR) isoforms. These receptors regulate gene expression and play a role in anti-fibrotic, anti-inflammatory, and metabolic processes. Inventiva believes that lanifibranor's balanced pan-PPAR binding profile contributes to its favorable tolerability. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH.
About the NATiV3 Phase 3 Trial
The NATiV3 trial is a pivotal Phase 3 clinical trial evaluating the efficacy and safety of lanifibranor in adult patients with MASH. MASH, a progressive chronic liver disease, represents a significant unmet medical need. The trial aims to assess lanifibranor's ability to resolve steatohepatitis and improve liver fibrosis, key endpoints in MASH treatment.
