IVEVF - Inventiva announces that screening in the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH has resumed | Benzinga
- Inventiva has lifted the voluntary pause on screening and randomization in the NATiV3 clinical trial following the approval from the US central IRB of the amended protocol and ICF.
- Screening of patients is resuming in sites operating under central IRB in the US.
- Other sites and countries are expected to resume screening and randomization activities progressively over the next weeks.
- Last Patient First Visit is currently targeted for first half 2024.
Daix (France), Long Island City (New York, United States), March 7, 2024 – 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 that it has lifted the previously disclosed1 voluntary pause on screening and randomization of its NATiV3 clinical trial and that sites are resuming screening activities.
Following the Suspected Unexpected Serious Adverse Reaction ("SUSAR") in a patient enrolled in the study, Inventiva chose to voluntarily pause screening and randomization of new patients in the NATiV3 trial to implement the recommendations of the independent Data Monitoring Committee ("DMC"), which included liver monitoring every 6 weeks for each patient enrolled in the trial, and amending the protocol to exclude newly screened patients diagnosed or with a predisposition to autoimmune liver and thyroid disease. In addition, the Company has made amendments to the Informed Consent Form ("ICF") in line with the DMC recommendations. During the pause, the DMC has continued to receive updates on the patient status and has reviewed and approved the amendments made to Inventiva's study documents.
Inventiva received the first approval from the central IRB overseeing clinical research in the United States. Clinical sites located in the United States operating under central IRB have meanwhile resumed screening and randomization activities. This is an important milestone as 152 sites of the NATiV3 clinical trial sites are operating under central IRB and have so far randomized over 60% of the patients in the main cohort. Inventiva expects to progressively obtain the approvals required by local authorities to restart screening and randomization in other countries over the next few weeks.
Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: "The well-being of our patients is paramount in our clinical research, and we are delighted to see that the patient who experienced the SUSAR is expected to make a full recovery. We want to thank all sites and all patients currently enrolled and in screening for their dedication to our study. Our team has worked diligently, and we are pleased to see screening and randomization resuming in our American sites under central IRB. Our sites operating under central IRB have contributed to more than 60% of all patients randomized in the trial and we expect them to be key in securing the last patients needed to finalize enrollment. Our ongoing interactions with the NATiV3 sites give us confidence in their strong commitment to resume the recruitment activities and we are looking forward to completing enrollment in the NATiV3 study with their support."
Prior to the voluntary pause, 913 patients were already randomized in the NATiV3 clinical trial including 731 in the main cohort and over 550 patients were in screening. Inventiva anticipates the last patient first visit for the NATiV3 clinical trial in the first half of 2024.
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 takes place in 24 countries and in more than 400 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 anticipated to enrol approximately 200 patients with NASH and ...