{"id":50180,"date":"2022-10-27T18:02:02","date_gmt":"2022-10-27T16:02:02","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/valbiotis-will-present-significant-preclinical-results-for-its-active-substance-totum448-against-fatty-liver-diseases-nafl-and-nash-at-the-annual-meeting-of-the-american-association-for-th\/"},"modified":"2022-10-27T18:02:02","modified_gmt":"2022-10-27T16:02:02","slug":"valbiotis-will-present-significant-preclinical-results-for-its-active-substance-totum448-against-fatty-liver-diseases-nafl-and-nash-at-the-annual-meeting-of-the-american-association-for-th","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/valbiotis-will-present-significant-preclinical-results-for-its-active-substance-totum448-against-fatty-liver-diseases-nafl-and-nash-at-the-annual-meeting-of-the-american-association-for-th\/","title":{"rendered":"Valbiotis Will Present Significant Preclinical Results for Its Active Substance TOTUM\u2022448 Against Fatty Liver Diseases (NAFL and NASH), at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nTOTUM\u2022448 is an innovative plant-based patented active substance developed by Valbiotis, a young French SME, to counteract the development of metabolic liver diseases (NAFL and NASH<sup>1<\/sup>).\n<\/li>\n<li>\nIn two preclinical models that mimic the development of fatty liver disease in humans, two studies demonstrate the broad efficacy of TOTUM\u2022448 on the key mechanisms of these diseases, from the earliest stages:<\/p>\n<ul class=\"bwlistcircle\">\n<li>\nReduction of fat accumulation in the liver, e.g. hepatic steatosis.\n<\/li>\n<li>\nReduction of hepatic inflammation, which causes damage to the liver.\n<\/li>\n<li>\nImprovement of certain markers of fibrosis.\n<\/li>\n<\/ul>\n<\/li>\n<li>\nThese very promising results have been selected for presentation at the annual meeting of the AASLD, the leading American learned society for liver diseases, in Washington (USA), November 4-8, 2022.\n<\/li>\n<li>\nMetabolic liver diseases (NAFL, NASH), linked to overweight, are spreading throughout the world and can lead to severe liver damage requiring transplantation; its early management is all the more essential as no treatment is yet available.\n<\/li>\n<li>\nThe studies were carried out by Valbiotis research teams at its Riom center (Puy-de-D\u00f4me), in collaboration with the Hospices Civils de Lyon, and by the University of Leiden (Netherlands).\n<\/li>\n<\/ul>\n<p>LA ROCHELLE, France&#8211;(BUSINESS WIRE)&#8211;Regulatory News:\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221027005658\/en\/1113003\/5\/LOGO-NOIR.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221027005658\/en\/1113003\/21\/LOGO-NOIR.jpg\"><\/a><\/p>\n<p>\nValbiotis (FR0013254851 \u2013 ALVAL, PEA \/ SME eligible), <b>a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, <\/b>will present the significant preclinical results of TOTUM\u2022448, a non-drug, plant-based active substance, against metabolic liver diseases (NAFL and NASH), at the annual meeting of the American Association for the Study of Liver Diseases, from November 4 to 8, 2022. These results demonstrate the efficacy of TOTUM\u2022448 in the early stages of these diseases, on steatosis, inflammation and fibrosis of the liver. The two studies presented were conducted by Valbiotis teams at its R&amp;D center in Riom (Puy-de-D\u00f4me) in collaboration with the Hospices Civils de Lyon and by teams from the University of Leiden (Netherlands).\n<\/p>\n<p>\nPascal SIRVENT, Chief Scientific Officer, member of the Valbiotis Board of Directors, states: <i>&#8220;The excellent results that will be presented acknowledge extensive work in designing, refining and testing TOTUM\u2022448, an innovative plant-based active substance. TOTUM\u2022448 is the result of our combined expertise in plant-based substances and in metabolic diseases, and was specifically designed for metabolic liver diseases, or fatty liver diseases such as NASH. The selection of these results by the AASLD annual meeting, the world reference in the field, is a recognition of the real potential of TOTUM\u2022448 in metabolic liver diseases, which are growing rapidly worldwide and for which no specific treatment exists today. We would like to thank our academic partners on this project, the University of Leiden and the Hospices Civils de Lyon.&#8221;<\/i>\n<\/p>\n<p>\nTOTUM\u2022448 results: broad efficacy on key parameters of fatty liver diseases, from the earliest stages\n<\/p>\n<p>\nTwo studies will be presented at the AASLD world congress in two preclinical models of fatty liver diseases, which mimic the development of the disease in humans. They showed the efficacy of TOTUM\u2022448 on hepatic steatosis and inflammation and suggested an improvement in certain markers of fibrosis, the first three stages of the development of these diseases.\n<\/p>\n<p>\n<span class=\"bwuline\">First study: preventive efficacy of TOTUM\u2022448 against fatty liver disease<\/span>\n<\/p>\n<p>\nThis first protocol evaluated the efficacy of this active substance in preventing the development of fatty liver diseases in a model of induced obesity in golden hamsters. The animals were separated into four groups: a control group and three groups fed a high-fat diet, two of which were simultaneously supplemented with TOTUM\u2022448 at two different doses.\n<\/p>\n<p>\nAt the end of the study (12 weeks), TOTUM\u2022448 significantly reduced hepatic steatosis with a dose-dependent effect. This accumulation of triglycerides and cholesterol in the liver, a consequence of an excessively rich diet, is the first step in the development of metabolic liver diseases. Concurrent limitation of blood triglyceride and cholesterol levels was recorded, suggesting a major preventive effect of TOTUM\u2022448 on the regulation of lipid metabolism.\n<\/p>\n<p>\n<span class=\"bwuline\">Second study: the &#8220;curative&#8221; efficacy of TOTUM\u2022448 on already established fatty liver diseases<\/span>\n<\/p>\n<p>\nThis second &#8220;reversal&#8221; protocol evaluated the efficacy of TOTUM\u2022448 in a model of previously developed liver pathology. The animals were separated into five groups: a control group and four groups fed a high-fat diet only, for 12 weeks. Of these four groups that had developed liver disease, three were then supplemented with TOTUM\u2022448 for four weeks at three different doses while continuing their high-fat diet.\n<\/p>\n<p>\nBy the end of the study, TOTUM\u2022448 had reduced the level of fat in the liver (steatosis), but also reduced immune markers of liver inflammation and the ballooning score (swelling of the liver cells). At the same time, TOTUM\u2022448 produced marked positive effects on metabolic parameters strongly involved in the early stages of the disease (insulin sensitivity, glucose tolerance).\n<\/p>\n<p>\nIn both studies, TOTUM\u2022448 reduced the expression of genes involved in inflammation and liver fibrosis, two key steps in the progression of fatty liver diseases.\n<\/p>\n<p>\nVivien CHAVANELLE, PhD, Research officer and project manager of the TOTUM\u2022448 program for Valbiotis, comments: <i>&#8220;We have developed TOTUM\u2022448 for the management of fatty liver diseases in their early stages. The excellent results of these studies converge to demonstrate a strong efficacy of TOTUM\u2022448 on these very early key mechanisms of fatty liver diseases: the initial accumulation of fat in the liver and inflammation. Our data even suggest an effect on fibrosis, which is observed at slightly later stages. This is a real success and opens the way to an effective and totally new, non-drug preventive approach. We are very proud to present these promising data to the scientific community and hepatology specialists gathered in Washington for the AASLD congress&#8221;.<\/i>\n<\/p>\n<p>\nNAFL and NASH: an alarming global picture\n<\/p>\n<p>\nMetabolic liver diseases or NAFLD (non-alcoholic fatty liver diseases) constitute a spectrum of diseases that extends from simple isolated non-alcoholic fatty liver (NAFL) to non-alcoholic steatohepatitis (NASH).\n<\/p>\n<p>\nThese liver diseases are closely related to other metabolic disorders (obesity, insulin resistance, dyslipidemia, type 2 diabetes, hypertension). Their global prevalence, including all stages, is estimated at 25% worldwide<sup>2<\/sup>.\n<\/p>\n<p>\nNAFL, the first stage of these diseases, is characterized by the accumulation of fat in the liver and is estimated to affect 18.5 to 23.5% adults in the world<sup>3<\/sup>. It progresses to NASH when inflammatory processes and then fibrosis damage the liver tissue. At this advanced stage, the risk of liver failure, cirrhosis and hepatocellular carcinoma increases. In the United States, NASH is now the second most common reason for liver transplantation<sup>4<\/sup>.\n<\/p>\n<p>\nNo proven therapeutic or preventive solution is yet available for these liver diseases.\n<\/p>\n<p>\nPosters presentation<br \/>\n<br \/>Poster: #2559<br \/>\n<br \/>Title: TOTUM\u2022448 improves diet-induced non-alcoholic steatohepatitis in golden Syrian hamsters fed a western-diet.<br \/>\n<br \/>Authors: Chavanelle V. <i>et al.<\/i>\n<\/p>\n<p>\nPoster: #2483<br \/>\n<br \/>Title: The novel plant-based active principle TOTUM\u2022448 decreases hepatic steatosis and inflammation in diet-induced NAFLD mice.<br \/>\n<br \/>Authors: Lambooij JM. <i>et al.<\/i>\n<\/p>\n<p>\nAbout Valbiotis\n<\/p>\n<p>\nValbiotis is a Research &amp; Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.<br \/>\n<br \/>Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic and cardiovascular dis-eases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine re-sources.<br \/>\n<br \/>Its products are intended to be licensed to players in the health sector.<br \/>\n<br \/>Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France \u2013 P\u00e9rigny, La Rochelle (17) and Riom (63) \u2013 and a subsidiary in Quebec City (Canada).<br \/>\n<br \/>Valbiotis is a member of the \u201cBPI Excellence\u201d network and has been recognized as an \u201cInnovative Company\u201d by the BPI label. Valbiotis has also been awarded \u201cYoung Innovative Company\u201d status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company.<br \/>\n<br \/>For more information about Valbiotis, please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.valbiotis.com&amp;esheet=52954406&amp;newsitemid=20221027005658&amp;lan=en-US&amp;anchor=www.valbiotis.com&amp;index=1&amp;md5=71770a257b7c1985f0828e97d219fea6\" rel=\"nofollow noopener\" shape=\"rect\">www.valbiotis.com<\/a>\n<\/p>\n<p class=\"bwalignr\">\nName: Valbiotis<br \/>\n<br \/>ISIN code: FR0013254851<br \/>\n<br \/>Ticker symbol: ALVAL<br \/>\n<br \/>EnterNext\u00a9 PEA-PME 150\n<\/p>\n<p>\nThis press release contains forward-looking statements about Valbiotis\u2019 objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to Valbiotis at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as certain risks and uncertainties, including those described in the Valbiotis Universal Registration Document filed to the French Financial Markets Regulator (AMF) on May 19, 2022. This document is available on the Company\u2019s website (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.valbiotis.com&amp;esheet=52954406&amp;newsitemid=20221027005658&amp;lan=en-US&amp;anchor=www.valbiotis.com&amp;index=2&amp;md5=eaa4d37e08e38f38ebb0e5533dbcd9f0\" rel=\"nofollow noopener\" shape=\"rect\">www.valbiotis.com<\/a>).<br \/>\n<br \/>This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis\u2019 shares or financial securities in any country.\n<\/p>\n<p>\n<sup>1<\/sup> NAFL: non-alcoholic fatty liver; NASH: non-alcoholic steatohepatitis.<br \/>\n<br \/><sup>2<\/sup> Younossi ZM et al. Global epidemiology of nonalcoholic fatty liver disease, Hepatology, 2016.<br \/>\n<br \/><sup>3 <\/sup>Internal estimation, based on Younossi ZM et al. Global epidemiology of nonalcoholic fatty liver disease, Hepatology, 2016.<br \/>\n<br \/><sup>4<\/sup> Cholankeril G, et al. Liver Transplantation for Nonalcoholic Steatohepatitis in the US: Temporal Trends and Outcomes. Dig Dis Sci. 2017.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nCorporate communication \/ Valbiotis<br \/>\n<br \/>Carole Rocher<br \/>\n<br \/>Communication and Public Affairs Director<br \/>\n<br \/>+33 6 77 82 56 88\n<\/p>\n<p>\nMarc Delaunay<br \/>\n<br \/>Communication Manager<br \/>\n<br \/>+33 5 46 28 62 58<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;m&#x65;&#100;&#x69;&#97;&#x40;&#118;&#x61;&#108;b&#105;o&#x74;i&#x73;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;e&#x64;&#105;a&#x40;&#118;&#x61;&#x6c;b&#x69;&#111;t&#x69;&#115;&#x2e;&#99;o&#x6d;<\/a>\n<\/p>\n<p>\nFinancial communication \/ Actifin<br \/>\n<br \/>St\u00e9phane Ruiz<br \/>\n<br \/>Associate Director<br \/>\n<br \/>+33 1 56 88 11 14<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#58;&#115;&#114;&#117;iz&#64;a&#x63;&#x74;&#x69;&#x66;&#x69;&#x6e;&#46;&#102;&#114;\" rel=\"nofollow noopener\" shape=\"rect\">&#x73;&#x72;&#x75;&#105;&#122;&#64;a&#x63;&#x74;&#x69;&#102;&#105;n&#46;&#x66;&#x72;<\/a>\n<\/p>\n<p>\nMedia Relations \/ PrPa<br \/>\n<br \/>Damien Maillard<br \/>\n<br \/>Operational Director<br \/>\n<br \/>+33 6 80 28 47 70<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#100;&#97;&#109;&#105;&#101;n&#46;ma&#x69;&#x6c;&#x6c;&#x61;&#x72;&#x64;&#x40;&#x70;&#114;&#112;&#97;&#46;&#102;r\" rel=\"nofollow noopener\" shape=\"rect\">&#100;&#x61;m&#105;&#x65;n&#46;&#x6d;a&#105;&#x6c;l&#97;&#x72;d&#64;&#x70;r&#112;&#x61;&#46;&#102;&#x72;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>TOTUM\u2022448 is an innovative plant-based patented active substance developed by Valbiotis, a young French SME, to counteract the development of metabolic liver diseases (NAFL and NASH1). In two preclinical models that mimic the development of fatty liver disease in humans, two studies demonstrate the broad efficacy of TOTUM\u2022448 on the key mechanisms of these diseases, &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/valbiotis-will-present-significant-preclinical-results-for-its-active-substance-totum448-against-fatty-liver-diseases-nafl-and-nash-at-the-annual-meeting-of-the-american-association-for-th\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50180","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Valbiotis Will Present Significant Preclinical Results for Its Active Substance TOTUM\u2022448 Against Fatty Liver Diseases (NAFL and NASH), at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/valbiotis-will-present-significant-preclinical-results-for-its-active-substance-totum448-against-fatty-liver-diseases-nafl-and-nash-at-the-annual-meeting-of-the-american-association-for-th\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Valbiotis Will Present Significant Preclinical Results for Its Active Substance TOTUM\u2022448 Against Fatty Liver Diseases (NAFL and NASH), at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"TOTUM\u2022448 is an innovative plant-based patented active substance developed by Valbiotis, a young French SME, to counteract the development of metabolic liver diseases (NAFL and NASH1). In two preclinical models that mimic the development of fatty liver disease in humans, two studies demonstrate the broad efficacy of TOTUM\u2022448 on the key mechanisms of these diseases, ... 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