{"id":46667,"date":"2022-07-28T08:01:49","date_gmt":"2022-07-28T06:01:49","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/valbiotis-announces-completion-of-recruitment-for-the-phase-ii-iii-reverse-it-clinical-study-with-totum63-against-prediabetes-in-partnership-with-nestle-health-science\/"},"modified":"2022-07-28T08:01:49","modified_gmt":"2022-07-28T06:01:49","slug":"valbiotis-announces-completion-of-recruitment-for-the-phase-ii-iii-reverse-it-clinical-study-with-totum63-against-prediabetes-in-partnership-with-nestle-health-science","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/valbiotis-announces-completion-of-recruitment-for-the-phase-ii-iii-reverse-it-clinical-study-with-totum63-against-prediabetes-in-partnership-with-nestle-health-science\/","title":{"rendered":"Valbiotis Announces Completion of Recruitment for the Phase II\/III REVERSE-IT Clinical Study With TOTUM\u202263 Against Prediabetes, in Partnership With Nestl\u00e9 Health Science"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nThe last volunteer was enrolled in the REVERSE-IT study; recruitment of the 600 participants in this international, multicenter, randomized, placebo-controlled clinical study is complete.\n<\/li>\n<li>\nThis Phase II\/III study is evaluating the efficacy of TOTUM\u202263, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage).\n<\/li>\n<li>\nThe primary objective of the study will be the reduction of fasting blood glucose levels after 24 weeks of TOTUM\u202263 supplementation compared to placebo; the results will be announced at the end of the study.\n<\/li>\n<li>\nThis Phase II\/III clinical study was co-designed by Nestl\u00e9 Health Science and Valbiotis, as part of the global strategic partnership between the two companies on TOTUM\u202263.\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\/20220727005561\/en\/1113003\/5\/LOGO-NOIR.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220727005561\/en\/1113003\/21\/LOGO-NOIR.jpg\"><\/a><\/p>\n<p>\nValbiotis (FR0013254851 \u2013 ALVAL, PEA\/SME eligible) (Paris:ALVAL), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces that it has completed the recruitment of 600 volunteers for the international multicenter Phase II\/III REVERSE-IT clinical study on TOTUM\u202263.\n<\/p>\n<p>\nThis randomized, placebo-controlled study evaluates the efficacy of TOTUM\u202263, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The primary objective will be the reduction of fasting blood glucose levels after 24 weeks of TOTUM\u202263 supplementation compared to placebo. The results will be communicated at the end of the study.\n<\/p>\n<p>\nThe Phase II\/III REVERSE-IT study was co-designed by the Valbiotis and Nestl\u00e9 Health Science medical and regulatory teams to demonstrate the efficacy of TOTUM\u202263 against prediabetes and untreated type 2 diabetes (early stage), as part of the global strategic partnership between the two companies. REVERSE-IT should confirm the positive results of the Phase II clinical study already obtained in a similar population with TOTUM\u202263.\n<\/p>\n<p>\nMurielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs and member of the Valbiotis Board of Directors, commented: \u201c<i>We have reached a very important milestone in the development of TOTUM\u202263 with the completion of enrollment in the Phase II\/III REVERSE-IT study<\/i>.<i> With 600 volunteers enrolled in more than 50 centers worldwide, REVERSE-IT is among the most ambitious studies of early dysglycemia, from prediabetes to early-stage type 2 diabetes, using non-drug approaches. We would like to thank all the teams involved in this project, as well as our partner Nestl\u00e9 Health Science<\/i>. <i>With a highly demanding design, REVERSE-IT was developed to provide comprehensive and robust efficacy data on these populations in preparation for the TOTUM\u202263 market launch.\u201d<\/i>\n<\/p>\n<p>\nThe randomized, double-blind, placebo-controlled Phase II\/III REVERSE-IT study includes 600 people with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). It should confirm the efficacy of TOTUM\u202263 at a dose of 5 g\/day (3 daily intakes) for 24 weeks on blood glucose abnormalities and other metabolic risk factors for type 2 diabetes, compared to a placebo. The protocol will evaluate the effect of TOTUM\u202263 on fasting blood glucose, the primary endpoint of the study, as well as on a number of secondary endpoints of interest, including two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat mass).\n<\/p>\n<p>\n<b>About TOTUM\u202263<br \/>\n<br \/><\/b>TOTUM\u202263 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.<br \/>\n<br \/>TOTUM\u202263 has already been shown to be safe and effective in healthy volunteers in a Phase I\/II clinical study. Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM\u202263 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes.<br \/>\n<br \/>In these subjects, who were also abdominally obese, TOTUM\u202263 also significantly reduced body weight and waist circumference.<br \/>\n<br \/>TOTUM\u202263 benefits from intellectual property validated by patents in the world&#8217;s leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand and national phases are still underway in a dozen other countries including Brazil and Australia. Production capacity for TOTUM\u202263 has been validated in accordance with North American and European standards. TOTUM\u202263 already has marketing authorizations related to its status in Europe.<br \/>\n<br \/>In February 2020, Valbiotis signed a long-term global strategic partnership with Nestl\u00e9 Health Science for the development and worldwide commercialization of TOTUM\u202263. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM\u202263 by Nestl\u00e9 Health Science on a worldwide scale, possibly before obtaining a health claim depending on the area. They will also fund the final stages of development of TOTUM\u202263.\n<\/p>\n<p>\n<b>About Valbiotis<\/b><br \/>Valbiotis 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 diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.<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 &#8220;BPI Excellence&#8221; network and has been recognized as an &#8220;Innovative Company&#8221; by the BPI label. Valbiotis has also been awarded &#8220;Young Innovative Company&#8221; 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%2F&amp;esheet=52793192&amp;newsitemid=20220727005561&amp;lan=en-US&amp;anchor=www.valbiotis.com&amp;index=1&amp;md5=16373e20ec30ef869930fe5f17cc82ac\" rel=\"nofollow noopener\" shape=\"rect\">www.valbiotis.com<\/a>\n<\/p>\n<p>\n\u00a0\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 approved by 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%2F&amp;esheet=52793192&amp;newsitemid=20220727005561&amp;lan=en-US&amp;anchor=www.valbiotis.com&amp;index=2&amp;md5=42ee17e61b83b75db1b04dd0d3fe76de\" 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> <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=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;&#109;e&#x64;&#x69;&#97;&#64;v&#x61;&#x6c;&#98;io&#x74;&#x69;&#115;&#46;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;e&#x64;&#105;&#x61;&#x40;v&#x61;&#108;&#x62;&#x69;o&#x74;&#105;&#x73;&#x2e;c&#x6f;&#109;<\/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;&#97;i&#x6c;&#x74;&#111;:&#x73;&#x72;&#117;i&#x7a;&#x40;&#97;c&#x74;&#x69;&#102;i&#x6e;&#46;&#102;r\" rel=\"nofollow noopener\" shape=\"rect\">&#x73;&#x72;&#x75;&#x69;&#x7a;&#x40;&#x61;&#x63;&#x74;&#x69;&#x66;&#105;&#110;&#46;&#102;&#114;<\/a>\n<\/p>\n<p>\nMedia Relations \/ PrPa<br \/>\n<br \/>Damien MAILLARD<br \/>\n<br \/>Director of Operations<br \/>\n<br \/>+33 6 80 28 47 70<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;&#x74;o&#58;&#x64;&#x61;&#x6d;i&#101;&#x6e;&#x2e;&#x6d;a&#105;&#x6c;&#x6c;&#x61;r&#100;&#x40;&#x70;&#x72;p&#97;&#x2e;&#x66;&#x72;\" rel=\"nofollow noopener\" shape=\"rect\">&#100;&#x61;&#109;&#x69;&#101;&#x6e;&#46;&#x6d;a&#105;&#x6c;&#108;&#x61;&#114;&#x64;&#64;&#x70;r&#112;&#x61;&#46;&#x66;&#114;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The last volunteer was enrolled in the REVERSE-IT study; recruitment of the 600 participants in this international, multicenter, randomized, placebo-controlled clinical study is complete. This Phase II\/III study is evaluating the efficacy of TOTUM\u202263, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/valbiotis-announces-completion-of-recruitment-for-the-phase-ii-iii-reverse-it-clinical-study-with-totum63-against-prediabetes-in-partnership-with-nestle-health-science\/\">[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-46667","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Valbiotis Announces Completion of Recruitment for the Phase II\/III REVERSE-IT Clinical Study With TOTUM\u202263 Against Prediabetes, in Partnership With Nestl\u00e9 Health Science - 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-announces-completion-of-recruitment-for-the-phase-ii-iii-reverse-it-clinical-study-with-totum63-against-prediabetes-in-partnership-with-nestle-health-science\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Valbiotis Announces Completion of Recruitment for the Phase II\/III REVERSE-IT Clinical Study With TOTUM\u202263 Against Prediabetes, in Partnership With Nestl\u00e9 Health Science - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"The last volunteer was enrolled in the REVERSE-IT study; recruitment of the 600 participants in this international, multicenter, randomized, placebo-controlled clinical study is complete. This Phase II\/III study is evaluating the efficacy of TOTUM\u202263, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The ... 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This Phase II\/III study is evaluating the efficacy of TOTUM\u202263, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The ... 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