The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. lanifibranor, inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the. 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 cookies track visitors across websites and collect information to provide customized ads. [lvca_accordion][lvca_panel panel_id=panel-5bc0ba5831260 panel_title=About Inventiva]Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. This press release contains forward-looking statements, forecasts and estimates with respect to Inventivas clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. All rights reserved. Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with significant unmet medical need in the areas of fibrosis, lysosomal storage disorders and oncology. Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. The cookies is used to store the user consent for the cookies in the category "Necessary". You can change your choices at any time by visiting your privacy controls. This cookie is set by GDPR Cookie Consent plugin. Lanifibranor is currently evaluated in a pivotal Phase III trial in NASH Inventiva will receive a $12 million upfront, $5 million in short term potential milestone payments, up to $290 million. Your purchase entitles you to full access to the . This cookie is set by GDPR Cookie Consent plugin. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Privacy Policy Legal Information. All rights reserved. The trial preparations are progressing according to schedule and Inventiva plans to initiate the trial in the first half of 2021. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on managements beliefs. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, believes, anticipates, expects, intends, plans, seeks, estimates, may, will and continue and similar expressions. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. These cookies track visitors across websites and collect information to provide customized ads. On October 5, the company announced that it had been chosen to present the results . In mice studies, IVA337 was associated with decreased extracellular matrix (ECM) deposition and reduced expression of phosphorylated SMAD2/3-intracellular effector of transforming growth factor (TGF)-1. About lanifibranor. Necessary cookies are absolutely essential for the website to function properly. Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the . Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. The researchers concluded that lanifibranor is the first therapy to demonstrate both NASH resolution and improvement in fibrosis. The cookie is used to store the user consent for the cookies in the category "Analytics". 49% of patients in the lanifibranor 1200mg/day dose group achieved the primary endpoint compared to 27% in the placebo arm. Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Please refer to the Universal Registration Document filed with the Autorit des Marchs Financiers on June 19, 2020 under n D.20-0551 and its amendment filed on July 10, 2020 under n D. 20-0551-A01 as well as the half-year financial report on June 30, 2020 for additional information in relation to such factors, risks and uncertainties. You also have the option to opt-out of these cookies. Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that modulates key metabolic, inflammatory, and fibrogenic pathways in the pathogenesis of NASH. The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. Lanifibranor (IVA337) is a moderately potent and well-balanced pan-PPAR agonist (Boubia et al., 2018 ). We also use third-party cookies that help us analyze and understand how you use this website. About lanifibranor. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. However, you may visit "Cookie Settings" to provide a controlled consent. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. Necessary cookies are absolutely essential for the website to function properly. Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Analytical cookies are used to understand how visitors interact with the website. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. The cookie is used to store the user consent for the cookies in the category "Other. By clicking Accept all you agree that Yahoo and our partners will process your personal information, and use technologies such as cookies, to display personalised ads and content, for ad and content measurement, audience insights, and product development. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on managements beliefs. By clicking Accept All, you consent to the use of ALL the cookies. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. In this 24-week clinical trial, lanifibranor, an orally-available small molecule and the only pan-PPAR agonist5 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 score6 (combining hepatocellular inflammation and ballooning), compared to baseline, with no worsening of fibrosis. Additional supportive efficacy analyses on lipids and insulin resistance are planned in order to further demonstrate the effect of lanifibranor in NASH patients. INVENTIVA. This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. lanifibranor, inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by. This website uses cookies to improve your experience while you navigate through the website. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, believes, anticipates, expects, intends, plans, seeks, estimates, may, will and continue and similar expressions. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a wellbalanced activation of PPAR and PPAR, and a partial activation of PPAR. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. ICH GCP; Registro de ensaios clnicos dos EUA; Pgina Nct de ensaios clnicos; Estudo de prova de conceito controlado por placebo para avaliar a segurana e eficcia do lanifibranor sozinho e em combinao com o inibidor de SGLT2 EmpaGliflozina em pacientes com EHNA e Diabetes Mellitus tipo 2 Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Inventiva will also be present with a booth: we are inviting you to visit us from Friday 4 th through Monday 7 th, during exhibition hall opening hours at booth #548 located in the exhibition hall of the conference center.. About lanifibranor . We also use third-party cookies that help us analyze and understand how you use this website. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. The preparation of this pivotal Phase III trial is well on track and we are looking forward to its initiation in the first half of 2021, as previously announced.. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Actual events are difficult to predict and may depend upon factors that are beyond Inventivas control. These cookies ensure basic functionalities and security features of the website, anonymously.