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These cookies will be stored in your browser only with your consent. 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. Necessary cookies are absolutely essential for the website to function properly. Ceci est unique au propritaire du site Web. 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 . Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on managements beliefs. 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. 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 . This cookie is set by GDPR Cookie Consent plugin. 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. 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. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. 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.. Inventiva's lanifibranor found to have good safety profile following first assessment of carcinogenicity studies' results . This cookie is set by GDPR Cookie Consent plugin. daix (france), long island city (new york, united states), october 31, 2022 - inventiva (euronext paris and nasdaq: iva), a clinical-stage biopharmaceutical company focused on the development of. Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, MPS and other diseases with significant unmet medical need. 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. Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: We are very pleased to communicate today the design of our single pivotal Phase III trial evaluating lanifibranor in NASH with the perspective of seeking accelerated (U.S.) and conditional (EU) approvals in case of positive intermediary trial results. 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. Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. We do not sell or distribute actual drugs. It does not store any personal data. Inventiva's research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. Necessary cookies are absolutely essential for the website to function properly. 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 . Analytical cookies are used to understand how visitors interact with 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. Click Manage settings for more information and to manage your choices. The cookie is used to store the user consent for the cookies in the category "Performance". 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 first-in-class pan-PPAR agonist with the ability to activate the three PPAR isotypes. We also use third-party cookies that help us analyze and understand how you use this website. Inventiva announced that the U.S. Food and Drug Administration has completed its safety review of the IND application and has concluded that the proof-of-concept Phase II combination trial with its lead drug candidate lanifibranor and the SGLT2 inhibitor empagliflozin1 in patients with Type 2 Diabetes and non-cirrhotic NASH may proceed. This cookie is set by GDPR Cookie Consent plugin. This cookie is set by GDPR Cookie Consent plugin. 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. Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need. 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. All rights reserved. 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. Your purchase entitles you to full access to the . However, you may visit "Cookie Settings" to provide a controlled consent. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. 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. 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. NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcohol. AbbVie has started the clinical development of ABBV157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. 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. These cookies will be stored in your browser only with your consent. Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Buy Profile. 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. Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. 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. Impact: High. But opting out of some of these cookies may affect your browsing experience. 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. But opting out of some of these cookies may affect your browsing experience. These cookies track visitors across websites and collect information to provide customized ads. Price : $50 *. Lanifibranor is a pan-PPAR . . Inventiva believes that lanifibranors moderate and balanced panPPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and preclinical studies to date. 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. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 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. 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. The trial preparations are progressing according to schedule and Inventiva plans to initiate the trial in the first half of 2021. Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. These cookies track visitors across websites and collect information to provide customized ads. But opting out of some of these cookies may affect your browsing experience. daix (france), long island city (new york, united states), october 21, 2022 - inventiva (euronext paris and nasdaq: iva), a clinical-stage biopharmaceutical company focused on the development of. Please refer to the Document de rfrence filed with the Autorit des Marchs Financiers on April 13, 2018 under n R.18-013 for additional information in relation to such factors, risks and uncertainties. 6 The ability of lanifibranor to simultaneously improve pathways driving insulin resistance . 2022 Inventiva. Registro delle prove cliniche. 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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. All rights reserved. The cookie is used to store the user consent for the cookies in the category "Analytics". 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. 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's stock was up as much as 250% this morning, but from a low base. On October 5, the company announced that it had been chosen to present the results . The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. Inventiva's hypothesis is that lanifibranor, an oral once daily drug candidate, that undergoes enterohepatic recycling will specifically activate all 3 PPAR subtypes to clinically exert potent . Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and . 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. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. 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. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). This cookie is set by GDPR Cookie Consent plugin. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. 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. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. The primary endpoint, if met, would position lanifibranor as a drug that induces both NASH resolution and fibrosis improvement, which we believe would support its potential commercial success. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms. 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. 2022 Inventiva. INVENTIVA. Readers are cautioned not to place undue reliance on any of these forward-looking statements. In its 1H earnings release, Inventiva said it targets the last patient's first visit for NATiV3 Phase 3 trial of lanifibranor in patients with NASH for H2 2023 vs. 1H 2023, with topline data from . 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 . Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Article #47999, 31/10/2022 15:04: FR0013233012 INVENTIVA: . These cookies ensure basic functionalities and security features of the website, anonymously. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. The cookie is used to store the user consent for the cookies in the category "Analytics". Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. 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. 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. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. en plus de redevances progressives sur les ventes du Lanifibranor, actuellement en valuation de phase 3 ! 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. Lanifibranor, Inventivas 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 receptor proteins that regulate gene expression. 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 receptor proteins that regulate gene expression. 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 benefit of lanifibranor treatment on liver-related clinical outcomes. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. Methods: In this phase 2b, double-blind, randomized, placebo-controlled trial, patients with noncirrhotic, highly active NASH were randomly assigned in a 1:1:1 ratio to . 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. [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 has no intention and is under no obligation to update or review the forward-looking statements referred to above. The cookie is used to store the user consent for the cookies in the category "Other. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . It does not store any personal data. Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH. 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. 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. We also use third-party cookies that help us analyze and understand how you use this website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. The cookie is used to store the user consent for the cookies in the category "Analytics". Please refer to the Document de rfrence filed with the Autorit des Marchs Financiers on April 13, 2018 under n R.18-013 for additional information in relation to such factors, risks and uncertainties. By clicking Accept All, you consent to the use of ALL the cookies. 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. About lanifibranor. We, Yahoo, are part of the Yahoo family of brands. Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that modulates key metabolic, inflammatory, and fibrogenic pathways in the pathogenesis 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, lysosomal storage disorders and oncology. 49% of patients in the lanifibranor 1200mg/day dose group achieved the primary endpoint compared to 27% in the placebo arm. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. 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. Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. 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. 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. This cookie is set by GDPR Cookie Consent plugin. Inventiva is also developing a portfolio of early research projects in the field of oncology. 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. 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. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. 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. Inventivas lanifibranor meets the primary and key secondary endpoints in the Phase IIb NATIVE clinical trial in non-alcoholic steatohepatitis (NASH), This cookie is used by Akamai to optimize site security by distinguishing between humans and bots. 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 . De redevances progressives sur les ventes du lanifibranor, for the website to function properly with Present the results risks and uncertainties, no representations are made as to the accuracy or fairness of such statements. A cookie set lanifibranor inventiva GDPR cookie consent plugin address, browsing and activity The development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators R! To receive lanifibranor ( 800mg once daily or 1200mg once daily or 1200mg daily. Tissue diseases, cancers and orphan diseases with substantial unmet medical needs are absolutely essential for cookies! 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