IVEVF - Inventiva announces the positive recommendation of the third DMC of the Phase III clinical trial with lanifibranor in patients with NASH | Benzinga
- The DMC recommended to continue the clinical trial without modification of the protocol, based on the pre-planned review of safety data
- The safety assessment was based on the review of safety data from more than 500 patients, including patients that have been treated with lanifibranor for more than 72 weeks
- The DMC review remains consistent, confirming the good safety profile of lanifibranor
Daix (France), Long Island City (New York, United States), December 4, 2023 – Inventiva (NASDAQ:IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs, today announced the positive recommendation from the third meeting of the Data Monitoring Committee (DMC) to continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients with NASH without modification to the trial protocol. The DMC, composed of a group of independent experts, arrived at this recommendation after review of the safety data of patients enrolled in the NATiV3 trial.
The DMC review supports the continuation of the NATiV3 clinical trial, in the absence of a safety signal that would require any modification to the trial protocol. This safety assessment was based on the review of safety data from more than 500 patients, including patients that have been treated with lanifibranor for more than 72 weeks. This positive recommendation confirms the good safety and tolerability profile of lanifibranor.
Dr Michael Cooreman, Chief Medical Officer, commented: "We are pleased to see the continued good safety profile of lanifibranor in patients with NASH at this stage of our study as more patients are enrolled in the NATiV3 clinical trial and have been receiving treatment with lanifibranor for longer periods of time. As an orally-available small molecule and the only pan-PPAR agonist currently in clinical development for the treatment of NASH, lanifibranor has a unique mechanism of action, targeting the broad disease biology of NASH with fibrosis. We are very excited about the potential therapeutic benefits that it could bring to patients, if approved."
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 PPAR? and PPAR?, and a partial activation of PPAR?. 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 NASH. 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 pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.
About the NATiV3 Phase III trial
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 adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. The trial is designed to take place in approximately 24 countries and more than 350 clinical sites and to recruit approximately 900 patients to be treated over a 72-week period. The effect of lanifibranor will be assessed on several histological endpoints, including NASH resolution and improvement of fibrosis of at least one stage.
An exploratory cohort is included in parallel to the NATiV3 trial and is anticipated to include approximately 200 patients with NASH and fibrosis who are not eligible for the main NATiV3 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 potential accelerated approval to the Food and Drug Administration (FDA) and potential conditional approval to the European Medicines Agency (EMA) of lanifibranor for the treatment of NASH.
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