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. 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 . YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. We also use third-party cookies that help us analyze and understand how you use this website. These cookies ensure basic functionalities and security features of the website, anonymously. Inventiva - PR - P3 Design - EN - 050121 - VF, Patients with both resolution of NASH and improvement of fibrosis, A single global Phase III clinical trial evaluating two doses of lanifibranor (800mg and 1200mg once daily) versus placebo is intended to support U.S. New Drug Application (NDA) / EU marketing authorization, Seeking of U.S. accelerated approval and EU conditional approval for lanifibranor to be based on 72-week histology analysis in approximately 900 patients, Use of primary composite endpoint combining NASH resolution and fibrosis improvement, Inventiva confirms planned initiation of pivotal Phase III clinical trial in H1 2021. Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. 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). 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. Like . The cookie is used to store the user consent for the cookies in the category "Analytics". 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. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. 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. We, Yahoo, are part of the Yahoo family of brands. [/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. This website uses cookies to improve your experience while you navigate through the website. Lanifibranor SGLT2 EmpaGliflozin NASH 2 - 2 (SGLT2) EmpaGliflozin . YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. 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. 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. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. 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. It does not store any personal data. 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. 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Daix (France), January 5, 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 the details of the Phase III clinical trial with its lead drug candidate lanifibranor in NASH following the end-of-phase II meeting with the U.S. Food and Drug Administration (FDA) and the receipt of the Scientific Advice letter from the European Medicines Agency (EMA). Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. 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. This cookie is set by GDPR Cookie Consent plugin. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. Adis is an information provider. Latest Information Update: 28 Sep 2022. The Phase III trial design and clinical strategy have been discussed with both regulatory authorities and the following key points can be confirmed: * Two-sided p-values were calculated using Cochran Mantel Haenszel test, stratified on T2DM status** Two-sided p-value from Fisher exact test*** Two-sided p-value from Chi-squaretest. ICH GCP. 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. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. 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. 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. These cookies will be stored in your browser only with your consent. 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. YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. 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. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. Lo studio nella popolazione T2DM ha lo scopo di confermare l'effetto lanifibranor rispetto placebo sul controllo glicemico e valutare un effetto positivo . You also have the option to opt-out of these cookies. This cookie is set by GDPR Cookie Consent plugin. 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. Ceci est unique au propritaire du site Web. 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. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 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. Necessary cookies are absolutely essential for the website to function properly. 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. 3 Inventiva, 21121, Daix, France. These cookies ensure basic functionalities and security features of the website, anonymously. 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 . 4 Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine, Rowland Hill St., London, NW3 2PF, . 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. This cookie is set by GDPR Cookie Consent plugin. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. About lanifibranor . YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. The cookie is used to store the user consent for the cookies in the category "Performance". 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, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventivas business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. 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 . Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. Inventiva Pharma: ClinicalTrials.gov Identifier: NCT03008070 Other Study ID Numbers: IVA_01_337_HNAS_16_002 2016-001979-70 ( EudraCT Number ) First Posted: Inventiva's research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. 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. 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. 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 . 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. These cookies will be stored in your browser only with your consent. Analytical cookies are used to understand how visitors interact with the website. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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. 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. 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. 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. Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. 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. 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 "Analytics". The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. 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. Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that modulates key metabolic, inflammatory, and fibrogenic pathways in the pathogenesis of NASH. A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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. Based on the results, Inventiva will no longer proceed with the clinical development of lanifibranor for scleroderma. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration. Analytical cookies are used to understand how visitors interact with the website. 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. This cookie is set by GDPR Cookie Consent plugin. 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. 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. This website uses cookies to improve your experience while you navigate through the website. Statistical powering of 90% was considered for the sample size calculations of the Phase III clinical trial. Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. INVENTIVA. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. 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. 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. However, you may visit "Cookie Settings" to provide a controlled consent. 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 GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. 49% of patients in the lanifibranor 1200mg/day dose group achieved the primary endpoint compared to 27% in the placebo arm. 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. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". Lanifibranor is a pan-PPAR . The cookies is used to store the user consent for the cookies in the category "Necessary". 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. 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. 2022 Inventiva. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. 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 Final gross price and currency may vary according to local VAT and billing address. All rights reserved. Patients will be randomized 1:1:1 to receive lanifibranor (800mg once daily or 1200mg once daily) or placebo. 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. The cookies is used to store the user consent for the cookies in the category "Necessary". 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). 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. This cookie is set by GDPR Cookie Consent plugin. 2022 Inventiva. 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. These cookies ensure basic functionalities and security features of the website, anonymously. 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. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. But opting out of some of these cookies may affect your browsing experience. 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 . These cookies track visitors across websites and collect information to provide customized ads. 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. INVENTIVA : quand souffle le vent lger de la recovery ! Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on managements beliefs. January 05, 2021 16:00 ET This cookie is set by GDPR Cookie Consent plugin. Privacy Policy Legal Information. 2022 Inventiva. The trial would be completed on a post-marketing basis in the event that accelerated (U.S.) / conditional (EU) approval is received. Article #47999, 31/10/2022 15:04: FR0013233012 INVENTIVA: . Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on managements beliefs. These cookies will be stored in your browser only with your consent. 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. 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 cookies is used to store the user consent for the cookies in the category "Necessary". 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. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. 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. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. Analytical cookies are used to understand how visitors interact with the website. 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. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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 (IVA337) is a moderately potent and well-balanced pan-PPAR agonist (Boubia et al., 2018 ). Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. 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. 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. 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. NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcohol. Find out more about how we use your information in our privacy policy and cookie policy. | Source: Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Your purchase entitles you to full access to the . It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a whollyowned research and development facility. 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. It does not store any personal data. All rights reserved. We also use third-party cookies that help us analyze and understand how you use this website. Actual events are difficult to predict and may depend upon factors that are beyond Inventivas control. Inventiva is also developing a portfolio of early research projects in the field of oncology. 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. 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.
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