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. Article #47999, 31/10/2022 15:04: FR0013233012 INVENTIVA: . Alternative Names: IVA-337. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. 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. 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. The trial would be completed on a post-marketing basis in the event that accelerated (U.S.) / conditional (EU) approval is received. The cookie is used to store the user consent for the cookies in the category "Performance". 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. This cookie is set by GDPR Cookie Consent plugin. Inventiva's lanifibranor found to have good safety profile following first assessment of carcinogenicity studies' results . 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. About lanifibranor . Ceci est unique au propritaire du site Web. 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). 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. Registro delle prove cliniche. 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. By clicking Accept All, you consent to the use of ALL the cookies. This cookie is set by GDPR Cookie Consent plugin. This website uses cookies to improve your experience while you navigate through the website. 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. 6 The ability of lanifibranor to simultaneously improve pathways driving insulin resistance . 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. 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. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. 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. 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. Lanifibranor SGLT2 EmpaGliflozin NASH 2 - 2 (SGLT2) EmpaGliflozin . A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. 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. 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 Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Necessary cookies are absolutely essential for the website to function properly. Final gross price and currency may vary according to local VAT and billing address. 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. 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. 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. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. 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. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. However, you may visit "Cookie Settings" to provide a controlled consent. Analytical cookies are used to understand how visitors interact with the website. But opting out of some of these cookies may affect your browsing experience. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. 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. 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. 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. Ces cookies sont utiliss pour collecter des informations sur la faon dont les visiteurs utilisent notre site Web. This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. This cookie is set by GDPR Cookie Consent plugin. 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. 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. 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 Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Inventiva's stock was up as much as 250% this morning, but from a low base. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. The cookie is used to store the user consent for the cookies in the category "Performance". 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. Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. All rights reserved. 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 . This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads. Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . 4 Centre for Rheumatology and Connective Tissue Diseases, UCL Division of Medicine, Rowland Hill St., London, NW3 2PF, . We do not sell or distribute actual drugs. 2022 Inventiva. 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. 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 cookie is set by GDPR Cookie Consent plugin. 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. This cookie is set by GDPR Cookie Consent plugin. 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. These cookies will be stored in your browser only with your consent. INVENTIVA : quand souffle le vent lger de la recovery ! 49% of patients in the lanifibranor 1200mg/day dose group achieved the primary endpoint compared to 27% in the placebo arm. Privacy Policy Legal Information. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. 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. 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, lysosomal storage disorders and oncology. Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and . Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. 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. 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. This cookie is set by GDPR Cookie Consent plugin. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. [/lvca_panel][/lvca_accordion], 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. The cookie is used to store the user consent for the cookies in the category "Analytics". Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. 2022 Inventiva. 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). 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 We also use third-party cookies that help us analyze and understand how you use this website. Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and . 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. 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 employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. On October 5, the company announced that it had been chosen to present the results . All rights reserved. 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. Adis is an information provider. 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. This website uses cookies to improve your experience while you navigate through the website. 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. 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. You also have the option to opt-out of these cookies. Actual events are difficult to predict and may depend upon factors that are beyond Inventivas control. 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. By clicking Accept All, you consent to the use of ALL the cookies. The cookie is used to store the user consent for the cookies in the category "Analytics". 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. Find out more about how we use your information in our privacy policy and cookie policy. Inventiva is also developing a portfolio of early research projects in the field of oncology. 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. 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. These cookies ensure basic functionalities and security features of the website, anonymously. These cookies ensure basic functionalities and security features of the website, anonymously. 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. The cookies is used to store the user consent for the cookies in the category "Necessary". 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. 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 . We also use third-party cookies that help us analyze and understand how you use this website. About lanifibranor. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms. Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. These cookies ensure basic functionalities and security features of the website, anonymously. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. 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. 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. 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. YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. This cookie is set by GDPR Cookie Consent plugin. NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcohol. You also have the option to opt-out of these cookies. These cookies will be stored in your browser only with your consent. The JSESSIONID cookie is used by New Relic to store a session identifier so that New Relic can monitor session counts for an application. You can change your choices at any time by visiting your privacy controls. Inventivas research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs. This cookie is set by GDPR Cookie Consent plugin. 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. Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. 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. 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 . All rights reserved. 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. About lanifibranor. 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. However, you may visit "Cookie Settings" to provide a controlled consent. This cookie is set by GDPR Cookie Consent plugin. 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. Actual events are difficult to predict and may depend upon factors that are beyond Inventivas control. Impact: High. 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. 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 body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear . The company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors . YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. 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. There was no significant difference between placebo and lanifibranor, Inventiva Pharmaceuticals ' investigational treatment for systemic sclerosis, in alleviating skin fibrosis in a Phase 2b study, the company announced. But opting out of some of these cookies may affect your browsing experience. INVENTIVA : un coup de grisou qu'il convient de relativiser ! This cookie is set by GDPR Cookie Consent plugin. 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 track visitors across websites and collect information to provide customized ads. Information about your device and internet connection, like your IP address, Browsing and search activity while using Yahoo websites and apps. Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. 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.
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