ClinicalConnection.com does not conduct or endorse this research . It demonstrated that Lanifibranor met fibrosis improvement and NASH resolution endpoints. 5. Therapies for non-alcoholic fatty liver disease: A 2022 update. Voir le profil de Valeria Bertaina sur LinkedIn, le plus grand rseau professionnel mondial. Lanifibranor regulates these functions by acting on nuclear receptors. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of 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. 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. Make a difference, share your experiences and get paid. 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. 1998-2022 Mayo Foundation for Medical Education and Research. Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH. Similar Structures. Study statuses change often. 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 aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). A Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define Lanifibranor (IVA337) Supra-therapeutic Dose in a Multiple Dosing Regimen This information was retrieved directly from the website clinicaltrials.gov without any changes. It may also offer cardiovascular benefits, but further investigation is required to know this for sure. FOIA consistent and proper use of highly effective method of contraception throughout the Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease. Now, it is time to move to the Phase 3 NATIVE3 trial, which expects to enroll its first participants this quarter. 16. History or current diagnosis of hepatocellular carcinoma HCC Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGlifl: . Lanifibranor continued to show a favorable tolerability profile, consistent with observations from previous clinical trials. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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 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. Mayo Clinic does not endorse any of the third party products and services advertised. Two regulatory agencies, the FDA and EMA, have already given this trial their approval. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. Epub 2019 Nov 4. Enter your details here to receive your free Report. Bethesda, MD 20894, Web Policies 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). 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. 5. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205. 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. 19. Pathogenesis and Therapeutic Strategies Related to Non-Alcoholic Fatty Liver Disease. Concomitant treatment with PPAR-alpha agonists (fibrates). Study Design Go to Based on the results, the company decided to discontinue lanifibranors development for dcSSc and focus on its potential use to treat nonalcoholic steatohepatitis (NASH). MOL SDF 3D-SDF PDB SMILES InChI. 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. 6. Contact the study team to discuss study eligibility and potential participation. 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. 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 . Phase 3 trials include large numbers of people to make sure that the result is valid. Thus, a phase 3 NATiV3 pivotal trial . N Engl J Med. Ann Gastroenterol. Guidelines differ from study to study, and identify who can or cannot participate. 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. Shen K, Singh AD, Modaresi Esfeh J, Wakim-Fleming J. Fibrosis score: F2 or F3 The trial also failed to meet any secondary endpoints. 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 Contemp Clin Trials. "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. Obesity related: Full results of the study will be presented at the AASLD meeting in November. 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. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Monday. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. 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. 6. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to It is under investigation in Phase 2 clinical trials for non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, and type 2 diabetes. Structure for Lanifibranor (DB14801) "While we have decided to discontinue the lanifibranor . 18. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Lanifibranor is the only product candidate in clinical development targeting all three PPAR isoforms. Inventiva's lanifibranor showed no signficant difference from placebo in alleviating skin fibrosis in a Phase 2b study with systemic sclerosis patients. 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. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. An official website of the United States government. Histologically documented liver cirrhosis (fibrosis stage F4) 2022 Sep 27;14(9):1718-1729. doi: 10.4254/wjh.v14.i9.1718. evaluation 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. Clinical trials Non-alcoholic steatohepatitis Download PDF A phase IIb double-blind, randomized, placebo-controlled trial investigated lanifibranor (a pan-proliferator-activated receptor. Federal government websites often end in .gov or .mil. While we have decided to discontinue the lanifibranor programme in SSc, we are very grateful for the dedication and commitment of patients, caregivers, investigators and our team to this programme. 2. 20. Before Pan-PPAR agonism indirectly inhibits hepatic macrophage infiltration, decreasing the pro-inflammatory activation of macrophages via PPAR agonism. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males Lanafibranor is also undergoing a Phase 2b clinical trial (NCT03008070), called NATIVE, investigating its efficacy in patients with NASH, a chronic liver disease. Keywords: 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. official website and that any information you provide is encrypted Unable to load your collection due to an error, Unable to load your delegates due to an error. Current treatment with insulin 2020 Apr;72(4):613-626. doi: 10.1016/j.jhep.2019.10.023. 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 8. 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Weight stable for 6 months prior to Screening and between the qualifying liver biopsy Negative serum pregnancy test at study Screening for females of childbearing potential I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the, Specialty drug launch strategy and operations, The next chapter of clinical trial services, Xgevas Safety and Efficacy Failings Put Future of Amgen Drug in Question, Nitric Oxide Synthase (NO Synthase or NOS or EC 1.14.13.39) Drugs in Development by Therapy Areas and Indications, Stages, MoA, RoA, Molecule Type and Key Players, Nonerosive Reflux Disease (NERD) Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players, PharmSource - Not So NICE: How Market Access Schemes Impact the CMO Sector, Premature Ovarian Failure Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players, Blue Lake reports positive data from Phase I RSV vaccine trial, Cholesterol drug fails in Penn Medicine-led Covid-19 clinical trial, Rain reports initial Phase II data for solid tumour therapy, Number of ongoing Clinical Trials (for drugs) involving Nonerosive Reflux Disease (NERD) by Phase, Number of ongoing Clinical Trials (for drugs) involving Incomplete Emptying Of The Bladder by Phase, Number of ongoing Clinical Trials (for drugs) involving Unspecified by Phase, Pharma: Pharmaceutical Prices (POLI): Insights Package, NHS aims to eliminate healthcare inequalities for people with autism, mRNA non-vaccine therapeutics field set to reach $2 billion by 2028, Alphabet, Tencent, and Qualcomm are the top three innovative companies in the last 10 years, The scorecard finds Technology & Communications and Pharma & Healthcare as the two main sectors driving innovation, Loreal placed as Disruptive Leader in the Consumer sector, while Revlon has been identified as a traditional laggard, Companies such as Etsy and H&M are challenging retail Disruptive Leaders Amazon and Walmart. 10. 2022 May-Jun;35(3):213-225. doi: 10.20524/aog.2022.0704. Eligibilitylast updated 7/13/22. Positive human immunodeficiency virus (HIV) serology 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. 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. 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. Results showed a decrease in the average mRSS scores in active and placebo arms. Inclusion Criteria: Study: Phase 3 Trial Investigates Lanifibranor for NASH, Patient Worthy Content Submission Guidelines. All other chronically administered drugs must be stable for at least 3 months prior to Disclaimer, National Library of Medicine 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. Like the NATIVE study, the new trial will compare 800 mg and 1,200 mg doses of lanifibranor against a placebo. 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. 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. Among candidate drugs in clinical trials for NASH, only lanifibranor achieves significant results on FDA- and EMA-designated primary endpoints (Fraile et al. Cardiovascular related: Questions regarding updates should be directed to the study team contact. But Inventiva execs pointed out during the call that no patients dropped out of the study because of oedema. Types include: During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. 1. 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. "We are disappointed by the results of the FASST clinical trial in dcSS," said Frdric Cren, chairman and CEO of Inventiva. Metabolism. 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. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) 1. 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. 21. 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. 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. 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. 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). 4. Accessibility Liver fibrosis; NAS score; Nonalcoholic steatohepatitis; Peroxysomal proliferator-activated receptors; SAF score. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Harrison SA, Alkhouri N, Davison BA, Sanyal A, Edwards C, Colca JR, Lee BH, Loomba R, Cusi K, Kolterman O, Cotter G, Dittrich HC. 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. This site needs JavaScript to work properly. 23. 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