Keywords: Zhang F, Zhang Z, Li Y, Sun Y, Zhou X, Chen X, Sun S. Front Genet. "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. The pan-peroxisome proliferator-activated receptor (PPAR) agonist lanifibranor has recently completed testing in a phase IIb clinical trial in non-alcoholic steatohepatitis, reaching both primary and key secondary endpoints successfully. Pan-PPAR agonism indirectly inhibits hepatic macrophage infiltration, decreasing the pro-inflammatory activation of macrophages via PPAR agonism. 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 (, , ). "we are now fully dedicated to the development of our flagship product lanifibranor, a promising treatment in phase iii (last stage of clinical trials before possible commercialization, editor's note) of clinical development in nash, a disease for which there is currently no no drug approved by regulatory agencies," said frdric cren, chairman Enter your details here to receive your free Report. Bookshelf 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. This leads to inflammation and scarring which may go on to impact liver function. Contemp Clin Trials. Therapies for non-alcoholic fatty liver disease: A 2022 update. History or current diagnosis of hepatocellular carcinoma HCC Inclusion Criteria: Study Design Go to Careers. What rare disease(s)/conditions are most important to you? Epub 2019 Nov 13. Activity score: A3 or A4 Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more. Histologically documented liver cirrhosis (fibrosis stage F4) Liver-related: 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). The .gov means its official. Current or recent history (<5 years) of significant alcohol consumption Teng T, Qiu S, Zhao Y, Zhao S, Sun D, Hou L, Li Y, Zhou K, Yu X, Yang C, Li Y. Int J Mol Sci. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. 2. Download scientific diagram | Interrim results of selective drug trials for non-alcoholic fatty liver disease and liver fibrosis from publication: Management of liver diseases: Current . Current treatment with insulin Weight stable for 6 months prior to Screening and between the qualifying liver biopsy 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 . Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205. Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) Lanifibranor is the only product candidate in clinical development targeting all three PPAR isoforms. 5. 15. This study placed the investigational drug at the lead of the pack for NASH treatments currently in development. Statins: Stable dose for at least 3 months In vitro lanifibranor treatment improved the phenotype of hepatic cells taken from patients with ACLD. *** Unstable heart failure Diabetes mellitus other than type 2 Consultez le profil complet sur LinkedIn et dcouvrez les relations de Valeria, ainsi que des emplois dans des entreprises similaires. Named NATIVE3 (NASH lanifibranor Phase 3 trial), the planned trial has been designed as a double-blind, placebo-controlled global pivotal Phase III clinical trial to assess the potential. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of adult patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Fibrogenesis, and. Licensing & Acquisition Opportunity Analysis, https://inthought.com/wp-content/uploads/2019/03/inThought-Logo-Transparent-3.7.png, Phase 2b NATIVE Trial of Lanifibranor in NASH Meets Primary Endpoint. Epub 2019 Nov 4. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial. Unable to load your collection due to an error, Unable to load your delegates due to an error. The trial also failed to meet any secondary endpoints. Download . 14. These findings support further assessment of lanifibranor in phase 3 trials. Epub 2022 Apr 7. 7. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. French biopharmaceutical company Inventiva has reported findings from the Phase IIb FASST clinical trial of lanifibranor in patients with diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune, rheumatic disease. 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. "We are disappointed by the results of the FASST clinical trial in dcSS," said Frdric Cren, chairman and CEO of Inventiva. 9. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, Advertising and sponsorship opportunities. It may also offer cardiovascular benefits, but further investigation is required to know this for sure. Liver fibrosis; NAS score; Nonalcoholic steatohepatitis; Peroxysomal proliferator-activated receptors; SAF score. Study statuses change often. (check all that apply). There are also less common very early (phase 0) and later (phase 4) phases. MeSH official website and that any information you provide is encrypted 2021). From this analysis, the required sample size per group calls for 15 patients in each arm (lanifibranor vs. placebo) to complete treatment. FASST was conducted to assess lanifibranor in 145 patients with early phase of dcSSc over 48 weeks. Bethesda, MD 20894, Web Policies Obesity related: 2022 May-Jun;35(3):213-225. doi: 10.20524/aog.2022.0704. The https:// ensures that you are connecting to the Positive human immunodeficiency virus (HIV) serology Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH. Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver . Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. If all continues to go well, Lanifibranor could be on track to receive accelerated approval in the United States and conditional approval in the European Union. doi: 10.1053/j.gastro.2016.01.038. months from Screening or 5 half-lives from Screening, whichever is longer 2. Guidelines differ from study to study, and identify who can or cannot participate. Exclusion Criteria: Clinical trials Non-alcoholic steatohepatitis Download PDF A phase IIb double-blind, randomized, placebo-controlled trial investigated lanifibranor (a pan-proliferator-activated receptor. 6. 20. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. HHS Vulnerability Disclosure, Help 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. Additionally, the initial endpoints have been established as fibrosis improvement and NASH resolution after 72 weeks. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH. If you would like to be contacted by the clinical trial representative please fill out the form below. Atrial fibrillation requiring anticoagulation Epub 2016 Feb 11. Stable dose for the drugs listed below: Please enable it to take advantage of the complete set of features! Full results of the study will be presented at the AASLD meeting in November. 22. Eligibilitylast updated 7/13/22. Observational study observes people and measures outcomes without affecting results. 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A single copy of these materials may be reprinted for noncommercial personal use only. According to a recent article published in The Online Trading Mentor, Inventiva S.A. (Inventiva) has recently opened enrollment for its Phase 3 trial of Lanifibranor, an investigational treatment for nonalcoholic steatohepatitis (NASH). Based on the results, the company decided to discontinue lanifibranor's development for dcSSc and focus on its potential use to treat nonalcoholic steatohepatitis (NASH).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. Similar Structures. 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 . Participation eligibility Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Impact: High. Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. Statistically significant results were also obtained in both dose groups on decrease of insulin, fasting glucose and glycated haemoglobin (HB1AC) in patients with T2DM, decrease in triglycerides, increase in high density lipoprotein cholesterol (HDL) and decrease in liver enzymes (ALT, AST and GGT). 13. the results of the native trial were reported in june 2020 through a press release in which lanifibranor given for 24 weeks met the primary end point at the dose of 1200 mg/day with a significant decrease of at least 2 points in the saf activity score (steatosis, activity and fibrosis) (49% vs 27%, p = 0.004), compared to baseline, with no ALT or AST >5 ULN the qualifying liver biopsy; malabsorptive procedures and procedures combining both General safety: Now, it is time to move to the Phase 3 NATIVE3 trial, which expects to enroll its first participants this quarter. However, lanifibranor demonstrated favourable trend in global assessment of disease as well as favourable safety profile. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Valeria a 6 postes sur son profil. administered for at least 2 weeks within 12 months prior to qualifying liver biopsy 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. 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 Peroxysomal Proliferator-Activated Receptors, PPAR, / and , play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. 18. Accessibility Gastroenterology. Vijayakumar A, Okesli-Armlovich A, Wang T, Olson I, Seung M, Kusam S, Hollenback D, Mahadevan S, Marchand B, Toteva M, Breckenridge DG, Trevaskis JL, Bates J. Hepatol Commun. Combinations of an acetyl CoA carboxylase inhibitor with hepatic lipid modulating agents do not augment antifibrotic efficacy in preclinical models of NASH and fibrosis. Type Small Molecule Groups Investigational Structure. This site needs JavaScript to work properly. Magnetic. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy Lanifibranor regulates the three cardinal processes involved in the pathogenesis of NASH (Non-alcoholic steatohepatitis). Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. ClinicalConnection.com does not conduct or endorse this research . Like the NATIVE study, the new trial will compare 800 mg and 1,200 mg doses of lanifibranor against a placebo. All other chronically administered drugs must be stable for at least 3 months prior to inhibitors): Stable dose for at least 3 months Vitamin E (if at a dose 400 IU/day): Stable dose for at least 6 months Metabolism. 8600 Rockville Pike 2022 Jul 14;13:942153. doi: 10.3389/fgene.2022.942153. 2021). Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to 1. Federal government websites often end in .gov or .mil. "While we have decided to discontinue the lanifibranor . It is under investigation in Phase 2 clinical trials for non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, and type 2 diabetes. Types include: During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. Voir le profil de Valeria Bertaina sur LinkedIn, le plus grand rseau professionnel mondial. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 Thus, a phase 3 NATiV3 pivotal trial . Females of childbearing potential must practice a MOL SDF 3D-SDF PDB SMILES InChI. Structure for Lanifibranor (DB14801) 900 NASH patients with moderate to advanced fibrosis are expected to join the study. Please enter a work/business email address. Emerging advances in the pharmacologic treatment of nonalcoholic steatohepatitis and related cirrhosis. 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. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. 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. There is no specific criterion related to the fibrosis score except that patients with cirrhosis (F4) were excluded. Concomitant treatment with PPAR-alpha agonists (fibrates). Fibrosis score: F2 or F3 Results showed a decrease in the average mRSS scores in active and placebo arms. US Clinical Trials Registry; Kliniske forsg Nct side; Placebokontrolleret, Proof-of-Concept-undersgelse til evaluering af sikkerheden og effektiviteten af Lanifibranor alene og i kombination med SGLT2-hmmer EmpaGliflozin hos patienter med NASH og type 2-diabetes mellitus 23. Before Ann Gastroenterol. 6. Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease. Regardless, the investigators of this trial are optimistic about lanifibranors robust efficacy across FDA and EMA regulatory endpoints and it potential in phase 3 development. Inventiva's lanifibranor showed no signficant difference from placebo in alleviating skin fibrosis in a Phase 2b study with systemic sclerosis patients. Abnormal synthetic liver function as defined by Screening central laboratory 19. Medical records research uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. 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. 3. An official website of the United States government. Please contact the study team for the most up-to-date information regarding possible participation. Patient currently receiving any approved treatment for NASH or obesity Contract Manufacturing Organisation and Pharmaceutical Supply Services, Drug Processing Technology and Laboratory Equipment, Standardized Tools for Cellular Immune Assays, Thank you for subscribing to Clinical Trials Arena, Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. The purpose of this study is to evaluate the effectiveness and safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis. 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. About the Phase 3 Trial Not only are drug developers excited by the potential Lanifibranor holds to fill a gap regarding treatments for NASH, but they're motivated by the positive results of the previous Phase 2b NATIVE trial. View duration, location, compensation, and staffing details. Lanafibranor is also undergoing a Phase 2b clinical trial (NCT03008070), called NATIVE, investigating its efficacy in patients with NASH, a chronic liver disease. It will be randomized and double-blind with the intention of evaluating 800 mg QD and 1200 mg QD of Lanifibranor vs. placebo. 4. We believe that this pan-PPAR approach provides for a combination of anti-fibrotic, anti-inflammatory and beneficial metabolic effects that cannot be obtained with single and dual PPAR agonists. Efficacy, safety and effectiveness, after a new treatment has been approved and on... 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