1. Lanifibranor is an orally-available small molecule with breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) following a positive Phase IIb trial in patients with. Inventiva chairman and CEO Frdric Cren said: We are disappointed by the results of the FASST clinical trial in dcSSc, a challenging disease as evidenced by the recent failure of three other late-stage trials. Females of childbearing potential must practice a Observational study observes people and measures outcomes without affecting results. Partner With UsSubmit a StoryBecome a Contributor, Subscribe to Our NewsletterCheck Out Rare EventsGet Inspired By Our Memes, Sign Up With a Patient Worthy Account and Share Your Rare Story. Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of patients with NASH, a common and progressive chronic liver . Exclusion Criteria: 2022 Jul 14;13:942153. doi: 10.3389/fgene.2022.942153. It is under investigation in Phase 2 clinical trials for non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, and type 2 diabetes. 2016 May;150(5):1147-1159.e5. Summary This study will evaluate the efficacy of a 24-week treatment of NASH with lanifibranor based on histological evaluations (SAF score) by biopsy. The primary endpoint of the trial, the Steatosis Activity Fibrosis (SAF) score at Week 24 was met, along with all other secondary outcomes at the same time point, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH. Eligible Conditions Fatty Liver Non Alcoholic Steatohepatitis (NASH) Treatment Effectiveness Effectiveness Progress 2 of 3 This is further along than 85% of similar trials Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor- and-, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening. Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of patients with NASH, a common and progressive chronic liver . 14. Twenty-four weeks of treatment with lanifibranor, a drug designed to treat NASH, improved liver fibrosis in 42% of people treated in a phase 2b clinical trial, Professor Sven Francque of Antwerp University Hospital reported at the online AASLD Liver Meeting last month. The pharmaceutical industry's most comprehensive news and information delivered every month. It demonstrated that Lanifibranor met fibrosis improvement and NASH resolution endpoints. NATiV3 (NASH lanifibranor Phase 3 trial) is a randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating 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. Valeria a 6 postes sur son profil. History of heart failure with reduced left ventricular ejection fraction (LVEF) Please enable it to take advantage of the complete set of features! The trial also failed to meet any secondary endpoints. These positive data enter a mixed PPAR environment for NASH after Genfits PPAR/ agonist elafibranor failed an interim analysis of the phase 3 data and CymaBay did a U-turn on its own PPAR agonist seladelpar and resurrected its development after previously terminating it due to abnormal histology findings. 16. 3D. 2. Patients gained a mean of 2.4kg and 2.7kg in the 800mg and 1,200mg lanifibranor arms respectively, while 12 out of the 14 patients in the trial who reported peripheral oedema received lanifibranor. Gastroenterology. government site. If you would like to be contacted by the clinical trial representative please fill out the form below. The trial did not meet the primary endpoint of mean absolute change from baseline to week 48 in the modified Rodnan Skin Score (mRSS), compared to placebo. View duration, location, compensation, and staffing details. Unable to load your collection due to an error, Unable to load your delegates due to an error. MOL SDF 3D-SDF PDB SMILES InChI. 5. and Baseline (no more than 5% change for both periods) 11. Conservatively assuming that 10 % of the randomized patients will not complete the trial (dropouts), the total number of patients to be randomized is 33-34 patients. Liver fibrosis; NAS score; Nonalcoholic steatohepatitis; Peroxysomal proliferator-activated receptors; SAF score. This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2, with the following primary objectives: Part 1 To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology. In a phase 2 randomized trial named NATIVE (NCT03008070), 24 weeks of lanifibranor treatment achieved the primary endpoint of a significant reduction in the steatosis activity fibrosis score with. ALT or AST >5 ULN doi: 10.1053/j.gastro.2016.01.038. 3. This site needs JavaScript to work properly. 7. Inventiva's lanifibranor showed no signficant difference from placebo in alleviating skin fibrosis in a Phase 2b study with systemic sclerosis patients. Fibrosis score: F2 or F3 They also compare the safety of the new treatment with that of current treatments. The primary endpoint of the trial, the Steatosis Activity Fibrosis (SAF) score at Week 24 was met, along with all other secondary outcomes at the same time point, including NASH resolution with no . 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. In vitro lanifibranor treatment improved the phenotype of hepatic cells taken from patients with ACLD. 1. 10. Design NATIVE is a Phase 2b randomised, placebo-controlled, double-blind, parallel-assignment, dose-range study. The primary efficacy endpoint is a 2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis. Contact the study team to discuss study eligibility and potential participation. 18. Clipboard, Search History, and several other advanced features are temporarily unavailable. recently, in a phase 2b placebo-controlled randomized clinical trial testing the efficacy of lanifibranor in nash ( nct01694849, the native trial), 247 obese patients with biopsy-proven nash were randomly assigned to three treatment arms: 83 patients received 1,200-mg lanifibranor daily, 83 of patients received 800-mg lanifibranor daily, and 81 Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Apply to this Phase 2 clinical trial treating Liver Diseases, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Type 2 Diabetes (T2DM), Diabetes Mellitus. This trial is testing a new drug, lanifibranor, to see if it can treat adults with a fatty liver disease called NASH, and who also have liver fibrosis stage 2 or 3. Zhang F, Zhang Z, Li Y, Sun Y, Zhou X, Chen X, Sun S. Front Genet. 2021). . This study placed the investigational drug at the lead of the pack for NASH treatments currently in development. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 2022 May-Jun;35(3):213-225. doi: 10.20524/aog.2022.0704. Magnetic. Enter your details here to receive your free Report. Interventional study (clinical trial) studies new tests, treatments, drugs, surgical procedures or devices. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. Lanifibranor is an orally-available small molecule with breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) following a positive Phase IIb trial in patients with non-alcoholic steatohepatitis (NASH). Lanifibranor is an oral, small molecule designed to activate all three peroxisome proliferatoractivated receptor (PPAR) receptor isoforms in order to trigger anti-fibrotic and anti-inflammatory changes. Inventiva recently announced details of a follow-up Phase III trial of lanifibranor, which aims to enroll 2,000 participants, after meeting with the Food and Drug Administration to discuss the Phase II findings. Two regulatory agencies, the FDA and EMA, have already given this trial their approval. 5. The major difference between lanifibranor and the other two PPAR agonists is its lack of selectivity, with moderate and wellbalanced activity on all three PPAR isoforms (, , ). Inclusion Criteria: 8600 Rockville Pike 22. Thus, a phase 3 NATiV3 pivotal trial . Lanafibranor is also undergoing a Phase 2b clinical trial (NCT03008070), called NATIVE, investigating its efficacy in patients with NASH, a chronic liver disease. 3. Patient currently receiving any approved treatment for NASH or obesity Study: Phase 3 Trial Investigates Lanifibranor for NASH, Patient Worthy Content Submission Guidelines. Lanifibranor continued to show a favorable tolerability profile, consistent with observations from previous clinical trials. 6. Additionally, the initial endpoints have been established as fibrosis improvement and NASH resolution after 72 weeks. Documented causes of chronic liver disease other than NASH Lanifibranor is an orally-available small molecule with breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) following a positive Phase IIb trial in patients with. Women currently breastfeeding Apart from lanifibranor, Inventiva pipeline includes odiparcil for the treatment of mucopolysaccharidoses and YAP-TEAD in oncology field. 17. Integrated Bioinformatics Analysis Identifies Robust Biomarkers and Its Correlation With Immune Microenvironment in Nonalcoholic Fatty Liver Disease. Home; Study Search; . While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more. eCollection 2022. administered for at least 2 weeks within 12 months prior to qualifying liver biopsy Ratziu V, Harrison SA, Francque S, Bedossa P, Lehert P, Serfaty L, Romero-Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee QM, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A; GOLDEN-505 Investigator Study Group. Consultez le profil complet sur LinkedIn et dcouvrez les relations de Valeria, ainsi que des emplois dans des entreprises similaires. Participation in any clinical trial investigational medicinal product/device within 3 Shen K, Singh AD, Modaresi Esfeh J, Wakim-Fleming J. Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. Make a difference, share your experiences and get paid. Using our in-house alternative datasets, we are excited to launch GlobalDatas, We remain confident in lanifibranors unique mechanism of action and will therefore continue to move forward, as planned, with its clinical development., Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. However, lanifibranor demonstrated favourable trend in global assessment of disease as well as favourable safety profile. Disclaimer, National Library of Medicine study and for 1 month after treatment discontinuation. 23. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Steatosis score 1 Weight stable for 6 months prior to Screening and between the qualifying liver biopsy Keywords: 2021). Current or recent history (<5 years) of significant alcohol consumption Lanifibranor is under investigation in clinical trial NCT03008070 (Phase 2b Study in NASH to Assess IVA337). Tick the boxes of the newsletters you would like to receive. Abnormal synthetic liver function as defined by Screening central laboratory In this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly. Study statuses change often. Participation eligibility Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. Not only are drug developers excited by the potential Lanifibranor holds to fill a gap regarding treatments for NASH, but theyre motivated by the positive results of the previous Phase 2b NATIVE trial. HHS Vulnerability Disclosure, Help 2022 Jul 16;23(14):7841. doi: 10.3390/ijms23147841. Epub 2019 Nov 4. More on NASH 12. Lanifibranor regulates the three cardinal processes involved in the pathogenesis of NASH (Non-alcoholic steatohepatitis). The FDA announces that a single pivotal phase 3 study may be sufficient to support a new drug application (NDA) submission (Fraile et al. Phase IIb study '' > < /a > an official website and that any information you provide is and. Representative please fill out the form below history or current diagnosis of hepatocellular carcinoma HCC 4 ):613-626.: Lead of the Peroxisome proliferator-activated Receptor- and-, Induces resolution of Nonalcoholic steatohepatitis affects those who very! 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