YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. 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. 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. Necessary cookies are absolutely essential for the website to function properly. 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. Final gross price and currency may vary according to local VAT and billing address. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. In the TRIIk-fib mouse strain, treatment with 100 mg/kg lanifibranor reduces the development of lung fibrosis and right ventricular hypertrophy induced by bleomycin or SU5416 . INVENTIVA : un coup de grisou qu'il convient de relativiser ! 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. Registro delle prove cliniche. This cookie is set by GDPR Cookie Consent plugin. Daix (France), Long Island City (New York, United States), September 21, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis. Nash - : Iva337, , --ich Gcp A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. January 05, 2021 16:00 ET [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. Inventiva and Sino Biopharm announce licensing and collaboration 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. 49% of patients in the lanifibranor 1200mg/day dose group achieved the primary endpoint compared to 27% in the placebo arm. Inventiva to End Development of Lanifibranor for Scleroderma Inventiva announces a scientific presentation at the AASLD The Liver YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Lanifibranor is a first-in-class pan-PPAR agonist with the ability to activate the three PPAR isotypes. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. This cookie is set by GDPR Cookie Consent plugin. Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. 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. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively. INVENTIVA. About lanifibranor. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in Necessary cookies are absolutely essential for the website to function properly. 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. This website uses cookies to improve your experience while you navigate through the website. The trial will remain blinded after the pre-specified histological analysis and continue in a total of approximately 2,000 patients until the occurrence of a pre-specified number of adverse liver-related clinical events, including progression to cirrhosis. 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. 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. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. The New England Journal of Medicine publishes the results of - BioSpace Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. . Improvement of fibrosis by at least one stage, NASH resolution and improvement of fibrosis in both dose groups (800mg/day and 1200mg/day), Decrease of insulin, fasting glucose and glycated haemoglobin (HB1AC) in patients with type 2 diabetes, Increase in high density lipoprotein cholesterol (HDL), Decrease in liver enzymes (ALT, AST and GGT). Phase 2b Study in NASH to Assess IVA337 - Full Text View Inventiva receives FDA Breakthrough Therapy designation for The cookie is used to store the user consent for the cookies in the category "Analytics". The cookies is used to store the user consent for the cookies in the category "Necessary". CymaBay And Inventiva: The Scientific Conversation On - SeekingAlpha The cookie is used to store the user consent for the cookies in the category "Analytics". 2022 Inventiva. Inventiva Pascaline Clerc VP of Global External Affairs media@inventivapharma.com +1 240 620 9175, Brunswick Yannick Tetzlaff, Tristan Roquet Montgon, Aude Lepreux Media relations inventiva@brunswickgroup.com +33 1 53 96 83 83, Patti Bank Managing Director ICR Westwicke Patti.Bank@westwicke.com D 415-513-1284 San Francisco, CA www.westwicke.com. Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Prove cliniche su NASH - Steatoepatite non alcolica: IVA337, Placebo Lanifibranor - Inventiva Pharma Inventiva's research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. 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. The trial would be completed on a post-marketing basis in the event that accelerated (U.S.) / conditional (EU) approval is received. However, you may visit "Cookie Settings" to provide a controlled consent. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. ICH GCP; US-Register fr klinische Studien; Klinische Studien Nct Page; Placebokontrollierte Proof-of-Concept-Studie zur Bewertung der Sicherheit und Wirksamkeit von Lanifibranor allein und in Kombination mit dem SGLT2-Inhibitor EmpaGliflozin bei Patienten mit NASH und Diabetes mellitus Typ 2 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. About lanifibranor. 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 . 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. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms. The FDAs dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates demonstrating the capacity to treat serious conditions and fill significant unmet medical needs. Inventivas Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor Completes Enrollment, This cookie is used by Akamai to optimize site security by distinguishing between humans and bots. Inventiva announces FDA decision that Fast Track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis, This cookie is used by Akamai to optimize site security by distinguishing between humans and bots. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. Download PDF Contacts Inventiva Frdric Cren About lanifibranor . www.inventivapharma.com, Inventiva Frdric Cren Chairman & CEO info@inventivapharma.com +33 3 80 44 75 00, Brunswick Group Yannick Tetzlaff / Tristan Roquet Montegon / Aude Lepreux Media relations inventiva@brunswickgroup.com +33 1 53 96 83 83, Westwicke, an ICR Company Patricia L. Bank Investor relations patti.bank@westwicke.com +1415513 1284. 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 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 body by activating all three peroxisome proliferator-activated receptor (ppar) isoforms, which are well-characterized nuclear receptor proteins that These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships. AMIRAL & PARTNERS | Rue de la bourse Readers are cautioned not to place undue reliance on any of these forward-looking statements. 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. Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . 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. 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. 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. | Source: Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH. 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 . Actual events are difficult to predict and may depend upon factors that are beyond Inventivas control. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. [/lvca_panel][lvca_panel panel_id=panel-5bc0ba5831260 panel_title=Important Notice]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. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. 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. Your purchase entitles you to full access to the . 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. These cookies ensure basic functionalities and security features of the website, anonymously. Home - Inventiva Pharma Lanifibranor SGLT2 EmpaGliflozin NASH 2 - 2 (SGLT2) EmpaGliflozin . Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Readers are cautioned not to place undue reliance on any of these forward-looking statements. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. This cookie is set by GDPR Cookie Consent plugin. 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 . Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. This website uses cookies to improve your experience while you navigate through the website. This cookie is set by GDPR Cookie Consent plugin. Lanifibranor's chances of success had looked slim after an earlier flop in the rare fibrotic disease systemic sclerosis, as well as the recent failures of other PPAR agonists including Genfit's elafibranor and Cymabay's seladelpar. But opting out of some of these cookies may affect your browsing experience. This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Inventiva gets a surprise hit in Nash | Evaluate Inventiva and Sino Biopharm announce licensing and collaboration 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. 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 . Inventiva announces the initiation of its pivotal Phase III clinical 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. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only panPPAR agonist in clinical development. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and . Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Lanifibranor is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory as well as beneficial metabolic changes in the body by activating each of the three PPAR isoforms, known as PPAR, PPAR and PPAR. Inventiva and Sino Biopharm announce licensing and collaboration Privacy Policy Legal Information. Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs. This cookie is set by GDPR Cookie Consent plugin. 2022 Inventiva. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. Lanifibranor, le candidat mdicament d'Inventiva le plus avanc, est actuellement valu dans le cadre de l'tude clinique pivot de Phase III NATiV3 pour le traitement de patients adultes . Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms. Inventiva Frdric Cren Chief Executive Officer info@inventivapharma.com +33 3 80 44 75 00, Aude Hillion/ Yannick Tetzlaff Media relations inventiva@brunswickgroup.com +33 1 53 96 83 83, Patti Bank Managing Director ICR Westwicke Patti.Bank@westwicke.com D 415-513-1284 San Francisco, CA www.westwicke.com. 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. Latest Information Update: 28 Sep 2022. Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Daix (France), June 15, 2020 Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced positive topline results from the Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor for the treatment of NASH. Privacy Policy Legal Information. Lanifibranor - an overview | ScienceDirect Topics Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. Lo studio nella popolazione T2DM ha lo scopo di confermare l'effetto lanifibranor rispetto placebo sul controllo glicemico e valutare un effetto positivo . 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. 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 body by activating all three peroxisome proliferatoractivated receptor (PPAR) isoforms, which are wellcharacterized nuclear . This cookie is set by GDPR Cookie Consent plugin. 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. 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. 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. Non-Alcoholic Steatohepatitis (NASH) Inventiva is developing lanifibranor for the treatment of NASH to address all the key features of this disease: accumulation of liver fat (steatosis), inflammation (hepatitis), injury of liver cells (ballooning), as well as scarring of the liver (fibrosis) that can ultimately lead to cirrhosis. 3 Inventiva, 21121, Daix, France. INVENTIVA Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Buy Profile. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil, in October 2020. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. INVENTIVA : quand souffle le vent lger de la recovery ! Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. These cookies ensure basic functionalities and security features of the website, anonymously. Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in . YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Privacy Policy Legal Information. The pll _language cookie is used by Polylang to remember the language selected by the user when returning to the website, and also to get the language information when not available in another way. ICH GCP. With these results, lanifibranor is the first drug candidate to achieve statistically significant results on the two Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints8 relevant for seeking accelerated approval during Phase III clinical development. These cookies will be stored in your browser only with your consent. Inventiva, headquartered in Daix, France, received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its Lanifibranor for nonalcoholic steatohepatitis (NASH). Lanifibranor also met multiple key secondary endpoints including: Statistically significant results were also obtained in both dose groups (800mg/day and 1200mg/day) on: With these results, lanifibranor is the first drug candidate to achieve statistically significant results on the two Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints8 relevant for seeking accelerated approval during Phase III clinical development. All rights reserved. Additional supportive efficacy analyses on lipids and insulin resistance are planned in order to further demonstrate the effect of lanifibranor in NASH patients. 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. These cookies track visitors across websites and collect information to provide customized ads. This cookie is set by GDPR Cookie Consent plugin. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. Alternative Names: IVA-337. You also have the option to opt-out of these cookies. 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. Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva : announces the initiation of its pivotal Phase III clinical The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. Representations are made as to the accuracy or fairness of such forward-looking statements Privacy Policy Legal information to... Chemistry, ADME and pharmacology platforms opt-out of these forward-looking statements ces cookies sont pour! Upon factors that are being analyzed and have not been classified into a category as yet visitors, source! Information on metrics the number of visitors, their source, and the pages they visit anonymously factors... Uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and.. 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