Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score 1. 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. 12. Positive human immunodeficiency virus (HIV) serology A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. Accessibility Pathogenesis and Therapeutic Strategies Related to Non-Alcoholic Fatty Liver Disease. 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. Copyright 2020. Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study. 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. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. Types include: During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. and transmitted securely. the qualifying liver biopsy; malabsorptive procedures and procedures combining both Additionally, the initial endpoints have been established as fibrosis improvement and NASH resolution after 72 weeks. (check all that apply). Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 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). 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. administered for at least 2 weeks within 12 months prior to qualifying liver biopsy There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. Liver fibrosis; NAS score; Nonalcoholic steatohepatitis; Peroxysomal proliferator-activated receptors; SAF score. Conclusions: 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 higher with the 1200-mg dose of lanifibranor than with placebo. 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 (, , ). Fibrosis score: F2 or F3 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. 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 Mayo Clinic does not endorse any of the third party products and services advertised. inhibitors): Stable dose for at least 3 months This site needs JavaScript to work properly. This study placed the investigational drug at the lead of the pack for NASH treatments currently in development. Patient currently receiving any approved treatment for NASH or obesity Describes the nature of a clinical study. Concomitant treatment with PPAR-alpha agonists (fibrates). World J Hepatol. Inclusion Criteria: 900 NASH patients with moderate to advanced fibrosis are expected to join the study. Combinations of an acetyl CoA carboxylase inhibitor with hepatic lipid modulating agents do not augment antifibrotic efficacy in preclinical models of NASH and fibrosis. Statins: Stable dose for at least 3 months This leads to inflammation and scarring which may go on to impact liver function. 21. Valeria a 6 postes sur son profil. 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. Pan-PPAR agonism indirectly inhibits hepatic macrophage infiltration, decreasing the pro-inflammatory activation of macrophages via PPAR agonism. 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. 9. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. government site. 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. Documented causes of chronic liver disease other than NASH Francque SM, Bedossa P, Ratziu V, Anstee QM, Bugianesi E, Sanyal AJ, Loomba R, Harrison SA, Balabanska R, Mateva L, Lanthier N, Alkhouri N, Moreno C, Schattenberg JM, Stefanova-Petrova D, Vonghia L, Rouzier R, Guillaume M, Hodge A, Romero-Gmez M, Huot-Marchand P, Baudin M, Richard MP, Abitbol JL, Broqua P, Junien JL, Abdelmalek MF; NATIVE Study Group. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) 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. What rare disease(s)/conditions are most important to you? Magnetic. 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. Boeckmans J, Natale A, Rombaut M, Buyl K, Rogiers V, De Kock J, Vanhaecke T, M Rodrigues R. Cells. Study statuses change often. PMC General safety: Lanifibranor continued to show a favorable tolerability profile, consistent with observations from previous clinical trials. 6. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more. Uncontrolled hypertension at Screening (values >160/100 mm Hg) 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. 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. 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). 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. 23. 17. History of or planned liver transplant Steatosis-Activity-Fibrosis (SAF): Study: Phase 3 Trial Investigates Lanifibranor for NASH, Patient Worthy Content Submission Guidelines. Therapies for non-alcoholic fatty liver disease: A 2022 update. 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. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to 2. Like the NATIVE study, the new trial will compare 800 mg and 1,200 mg doses of lanifibranor against a placebo. If and how the isoform-specific effects on hepatic macrophage biology translate to a differential effect on clinical outcomes remains to be seen, but it must be noted that elafibranor also achieved success at the phase 2 stage before failing its interim phase 3 analysis. 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. Epub 2016 Feb 11. Apart from lanifibranor, Inventiva pipeline includes odiparcil for the treatment of mucopolysaccharidoses and YAP-TEAD in oncology field. MeSH Unable to load your collection due to an error, Unable to load your delegates due to an error. Please enable it to take advantage of the complete set of features! Careers. The site is secure. Mathieu Petitjean is an experienced operational leader with 25 years of executive-level and international business experience in Healthcare Diagnostics and Medical Technology. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Shen K, Singh AD, Modaresi Esfeh J, Wakim-Fleming J. 2022 Jul 14;13:942153. doi: 10.3389/fgene.2022.942153. Cardiovascular related: Females of childbearing potential must practice a liver biopsy. months from Screening or 5 half-lives from Screening, whichever is longer 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. *** 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. ROTH Capital Partners remains very optimistic and bullish on Inventiva's Lanifibranor program addressing NASH and points out to investors that additional data is expected to come forth in H1/22 from its clinical trials in patients with non-alcoholic fatty liver disease (NAFLD) and Type 2 diabetes (T2DM). 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. Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGlifl: . 8600 Rockville Pike 14. 18. Epub 2022 Apr 7. The FDA announces that a single pivotal phase 3 study may be sufficient to support a new drug application (NDA) submission (Fraile et al. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial. 2022 Sep;6(9):2298-2309. doi: 10.1002/hep4.2011. Please enter a work/business email address. Activity score: A3 or A4 6. 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). 22. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. The trial is designed to provide valuable information on body weight evolution and body fat composition in patients with NASH and T2D when treated with lanifibranor and empagliflozin. Clinical trials Non-alcoholic steatohepatitis Download PDF A phase IIb double-blind, randomized, placebo-controlled trial investigated lanifibranor (a pan-proliferator-activated receptor. 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. HbA1c >9% at Screening First, its important to understand what NASH is. 2. Only four participants experienced increased mRSS over the duration of the trial. "We are disappointed by the results of the FASST clinical trial in dcSS," said Frdric Cren, chairman and CEO of Inventiva. ClinicalConnection.com is a resource that provides information on clinical trials and other research opportunities worldwide. Structure for Lanifibranor (DB14801) 1. These are: Inflammation. 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. Please contact the study team for the most up-to-date information regarding possible participation. Thus, a phase 3 NATiV3 pivotal trial . and Baseline (no more than 5% change for both periods) 2. Abnormal synthetic liver function as defined by Screening central laboratory Lanifibranor is under investigation in clinical trial NCT03008070 (Phase 2b Study in NASH to Assess IVA337). Consultez le profil complet sur LinkedIn et dcouvrez les relations de Valeria, ainsi que des emplois dans des entreprises similaires. Bookshelf There are also less common very early (phase 0) and later (phase 4) phases. Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease. 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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. Obesity related: Anti-NASH Drug Development Hitches a Lift on PPAR Agonism. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Monday. Inventiva's lanifibranor showed no signficant difference from placebo in alleviating skin fibrosis in a Phase 2b study with systemic sclerosis patients. sharing sensitive information, make sure youre on a federal The double-blind, randomised, placebo-controlled trial involved twice daily 400mg or 600mg per day lanifibranor in addition to standard of care. The number of responders according to the SAF Activity score-based definition from baseline to 24 weeks will be compared between groups and serves as primary endpoint. Objectives NATIVE study (EudraCT: 2016-001979-70, NCT: NCT03008070) aims to assess the safety and the efficacy of a 24-week treatment with lanifibranor (800 and 1200 mg/day) in adult non-cirrhotic NASH patients. 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. N Engl J Med. 20. Introduction Chronic liver disease (CLD) originates from a sustained hepatic injury that can vary in nature, with excessive alcohol consumption, unhealthy dietary habits, and HBV or HCV infection being the most common causes. Disclaimer, National Library of Medicine 24. 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 . Download . 2021). It demonstrated that Lanifibranor met fibrosis improvement and NASH resolution endpoints. Gastroenterology. Screening doi: 10.1053/j.gastro.2016.01.038. Among candidate drugs in clinical trials for NASH, only lanifibranor achieves significant results on FDA- and EMA-designated primary endpoints (Fraile et al. Lanifibranor (IVA337), a panPPAR agonist, by acting on these three different PPAR isotypes, combines pharmacological effects that could address the different components of the disease as demonstrated in preclinical models. 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. Metabolism. Voir le profil de Valeria Bertaina sur LinkedIn, le plus grand rseau professionnel mondial. 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. receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH. Get access to cutting edge treatment via Lanifibranor, Placebo. Daix (France), Long Island City (New York, United States), October 31, 2022 - Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a biopharmaceutical company specialized in the clinical development of small molecules administered orally for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidosis (MPS) and Illnesses with Unmet Medical Need, today announces . ALT or AST >5 ULN Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 2021). Full results of the study will be presented at the AASLD meeting in November. 3. Current treatment with insulin Vitamin E (if at a dose 400 IU/day): Stable dose for at least 6 months HHS Vulnerability Disclosure, Help 10. 2020 Apr;72(4):613-626. doi: 10.1016/j.jhep.2019.10.023. Women currently breastfeeding More on NASH in this 24-week clinical trial, lanifibranor, an orally-available small molecule and the only pan-ppar agonist 5 currently in clinical development for the treatment of nash, met the primary endpoint in the itt population at the dose of 1200mg/day with a statistically significant (p = 0.004) decrease of at least two points in the saf activity Participation in any clinical trial investigational medicinal product/device within 3 3D. Diabetes mellitus other than type 2 From this analysis, the required sample size per group calls for 15 patients in each arm (lanifibranor vs. placebo) to complete treatment. Home; Study Search; . 3. 11. Previous exposure to lanifibranor 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. Fibrogenesis, and. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 1. Eligible Conditions Fatty Liver Non Alcoholic Steatohepatitis (NASH) Treatment Effectiveness Effectiveness Progress 2 of 3 This is further along than 85% of similar trials Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. A single copy of these materials may be reprinted for noncommercial personal use only. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Two regulatory agencies, the FDA and EMA, have already given this trial their approval. It is under investigation in Phase 2 clinical trials for non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, and type 2 diabetes. 16. ClinicalConnection.com does not conduct or endorse this research . Stable dose for the drugs listed below: 2019 Dec 21;9(1):37. doi: 10.3390/cells9010037. 3. Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. J Hepatol. consistent and proper use of highly effective method of contraception throughout the official website and that any information you provide is encrypted Federal government websites often end in .gov or .mil. 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. 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. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males Lanifibranor is the first drug candidate to achieve significant effects on NASH resolution with no worsening of fibrosis and improvement of fibrosis with no worsening of NASH, the FDA and EMA primary endpoints relevant for seeking accelerated approval during future phase 3 clinical development. View duration, location, compensation, and staffing details. 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. Before Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Clipboard, Search History, and several other advanced features are temporarily unavailable. But Inventiva execs pointed out during the call that no patients dropped out of the study because of oedema. Zhang F, Zhang Z, Li Y, Sun Y, Zhou X, Chen X, Sun S. Front Genet. confirmed by central laboratory. 1. 2022 Sep 27;14(9):1718-1729. doi: 10.4254/wjh.v14.i9.1718. 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. 2. FASST was conducted to assess lanifibranor in 145 patients with early phase of dcSSc over 48 weeks. Male or female, aged 18 years at the time of signing informed consent Participation eligibility Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. 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. An official website of the United States government. 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. This next step forward is exciting for researchers and patients alike, especially as NASH currently faces an unmet medical need. 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. The company's clinical development plan has been validated by the EMA and the treatment has recently received a positive review by the Data Safety Monitoring Board (DSMB). 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. 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. Enter your details here to receive your free Report. Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPARagonist, lanifibranor, for the treatment of NASH. Lanifibranor regulates the three cardinal processes involved in the pathogenesis of NASH (Non-alcoholic steatohepatitis). Exclusion Criteria: Epub 2022 Jun 23. In vitro lanifibranor treatment improved the phenotype of hepatic cells taken from patients with ACLD. Make a difference, share your experiences and get paid. Design NATIVE is a Phase 2b randomised, placebo-controlled, double-blind, parallel-assignment, dose-range study. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Lanafibranor is also undergoing a Phase 2b clinical trial (NCT03008070), called NATIVE, investigating its efficacy in patients with NASH, a chronic liver disease. 2022 Jul 16;23(14):7841. doi: 10.3390/ijms23147841.
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