Valbiotis Announces the Large Success of the REVERSE-IT International Multicentric Phase II/III Clinical Study on TOTUM•63: Proven Efficacy on the Main Risk Factor of Developing Type 2 Diabetes
Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible) (Paris:ALVAL), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the large success of the REVERSE-IT Phase II/III clinical study on TOTUM•63. Conducted in 636 prediabetic and untreated type 2 diabetic patients (early stage), this international, multicentric, randomized and placebo-controlled study confirms the efficacy of TOTUM•63 in reducing fasting blood glucose at 2 and 3 intakes per day. These positive results trigger a lump sum payment of CHF 4 million from Nestlé Health Science as part of the global strategic partnership.
Sébastien PELTIER, co-founder and Chairman of the Valbiotis Executive Committee, comments: "I am extremely proud of the results of the REVERSE-IT study on TOTUM•63, which represent a major breakthrough in the fight against diabetes and its complications for people with prediabetes and untreated type 2 diabetes (early stage). We have provided unequivocal clinical evidence that TOTUM•63 is a promising solution for millions of people worldwide, helping to prevent the progression to type 2 diabetes. This is a groundbreaking and exciting moment for our company, and I would like to extend my warmest thanks to our employees, our partners including Nestlé Health Science, and especially to the patients who participated in this study. Together, we have accomplished something truly remarkable, and we are determined to continue our mission to develop innovative solutions to improve the health of people around the world. Beyond this great achievement, which opens up a new path, it is also a personal satisfaction, after almost 10 years of hard work."
Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science, comments: "We are thrilled with the completion of this large clinical study, gathering more than 600 patients, designed to rigorously evaluate TOTUM•63. This non-drug, plant-based active substance has the potential to significantly impact the management of early impairments of glucose metabolism."
Jean-Marie BARD, emeritus professor of biochemistry and hospital practitioner in pharmacy, scientific advisor of the REVERSE-IT study, President of the French Nutrition Society Scientific Committee, specifies: "With more than 600 patients included in more than 50 centers internationally, REVERSE-IT is one of the largest and most ambitious studies in the world with non-drug approaches to early dysglycemia, from prediabetes to the early stages of type 2 diabetes. The results of this study represent a significant breakthrough for these people with glycemic impairment and confirm the data already obtained in 2019 with the Phase II study, published in the journal Diabetes, Obesity and Metabolism in 2022. I am delighted to have participated in the clinical validation of this new approach. Many healthcare professionals will be able to provide a solution for their patients and change their clinical practices, which until now have been limited to lifestyle recommendations alone."
The REVERSE-IT study was co-designed with Nestlé Health Science's medical teams as part of the global strategic partnership between Valbiotis and Nestlé Health Science signed in February 2020. Under this agreement, positive results of the REVERSE-IT study on the primary endpoint trigger a lump sum payment of CHF 4 million from Nestlé Health Science to Valbiotis. This milestone payment from Nestlé Health Science will occur upon submission of the full study report during the summer.
The REVERSE-IT study and its results on its primary endpoint
The randomized and placebo-controlled REVERSE-IT Phase II/III study included 636 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage).
The volunteers were divided into three equally balanced arms, each with more than 200 participants. In the intervention arm, participants were supplemented with TOTUM•63 at a dose of 5 g/day in three daily intakes. To complete the study, a second open-label arm evaluated a similar dose of 5 g of TOTUM•63 in two daily intakes.
The REVERSE-IT study met its two objectives on its primary endpoint, fasting blood glucose, with a high statistical significance on the data obtained in ITT (Intention To Treat):
- the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in three daily intakes, compared to placebo (p=0.015);
- the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in two daily intakes, compared to placebo.
The statistical analysis conducted in the per protocol population also confirms the statistical significance of these two results.
At the end of all the analyses, the comprehensive results of the study will be communicated in a subsequent press release, on the secondary endpoints and exploratory analysis, and submitted for presentation at international congresses and publication in international peer-reviewed journals.
TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.
TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India, South Korea and national phases are currently ongoing in Brazil, Argentina, Canada, Thailand, Qatar and the United Arab Emirates
Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe.
In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a global scale, possibly before obtaining a medical clearance depending on the area. They will also fund the final stages of development of TOTUM•63.
Valbiotis is a commercially oriented Research & Development company, committed to scientific innovation forpreventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.
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 diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Internationally, its products are intended to be the subject of licensing and/or distribution agreements with global or regional health and nutrition players. In France, Valbiotis will be responsible for marketing its own products.
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 – Périgny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis 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.
For more information about Valbiotis, please visit: www.valbiotis.com.
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150
This press release contains forward-looking statements about Valbiotis’ 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 April 26, 2023. This document is available on the Company’s website (www.valbiotis.com). 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’ shares or financial securities in any country.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230522005409/en/
Corporate Communication / Valbiotis
Communication and Public Affairs Director
+ 33 6 77 82 56 88
Financial communication / Seitosei Actifin
+33 1 56 88 11 14
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
In Industry First, PUMA Creates Sustainability Report Podcast Series to Reach Out to Gen-Z1.6.2023 11:00:00 EEST | Press release
Sports company PUMA has created a podcast series to make its 2022 Sustainability Report more accessible and to reach a wider and younger audience. The RE:GEN REPORTS podcast features next-generation thinkers from six countries and distills the content of the report into 10 podcast episodes, of which the first three are available on all major podcast platforms on June 1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005537/en/ Sports company PUMA has created a podcast series to make its 2022 Sustainability Report more accessible and to reach a wider and younger audience. (Photo: Business Wire) The RE:GEN REPORTS podcast, as well as the recently announced Voices of a Re:Generation project, comes as a direct result of the feedback PUMA received at last year’s Conference of the People, which the company organized to discuss solutions for some of the fashion industry’s most pressing sustainability challenges with Gen-Z rep
invoX Pharma Increases Investment in pHion Therapeutics to Further Develop Next Generation of mRNA Vaccines1.6.2023 11:00:00 EEST | Press release
invoX Pharma Limited (“invoX”), a U.K.-based wholly-owned subsidiary of Sino Biopharmaceutical Limited (“Sino Biopharm”) (HKEX 1177 HK) with an advancing pipeline of innovative products, today announced that it has completed a second tranche of investment in pHion Therapeutics (“pHion”), a next-generation mRNA vaccine company. The transaction supports invoX’s strategy to be a fully integrated biopharmaceutical company and its ongoing commitment to deliver innovative life-saving therapies pHion is developing a pipeline of therapeutic and prophylactic vaccines focussed on oncology and infectious diseases. The company’s proprietary RALA platform can deliver anionic molecules such as mRNA and saRNA in a stealth-like way, evading detection, to generate a potent antigen-specific CD8+ T-cell response. The RALA peptide-based drug delivery system is based on a sequence of 30 amino acids which condenses anionic cargo, irrespective of size, into nanoparticles that are highly efficient at cellular
AVEVA Recognized as a Leader in the IDC MarketScape: Worldwide Process Manufacturing Execution System 2023 Vendor Assessment1.6.2023 10:00:00 EEST | Press release
AVEVA, a global leader in industrial software, driving digital transformation and sustainability, announced that it has been positioned in the Leaders Category in the IDC MarketScape: Worldwide Process Manufacturing Execution System 2023 Vendor Assessment (doc # EUR150526323, April 2023). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005060/en/ Keith Chambers, Vice-President, Operations Management Software, AVEVA. (Photo: Business Wire) According to the IDC MarketScape, “AVEVA MES is a model-driven solution that supports the modelling of operational workflows, production processes, and equipment. This configurable business process management approach enables standardization of operational processes across multisite operations and provides a centralized management platform for data analysis with visualization.” In explaining the strengths of AVEVA MES, the report said, “The model-driven and process-based approach have
Convincing Across the Board: LR Health & Beauty Receives Yet Another Award for Innovative Beauty Product1.6.2023 09:30:00 EEST | Press release
It’s been about four months since the top seller product “LR Zeitgard Pro Cosmetic Device” has been recognized for its outstanding design. Now, another award in the “Bath and Wellness” category has brought a cheerful mood to health & beauty product providers: Zeitgard Pro may now be presented with an additional “special mention” of the German Innovation Award 2023 – proving its ability to stand out among others as a cosmetic device for home use with exceptional user-centred design and surplus value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230531005576/en/ LR Health & Beauty receives the German Innovation Award for the Zeitgard Pro. (Graphic: Business Wire) “This renewed recognition proves that, with Zeitgard Pro, we managed to partially revolutionise the beauty industry”, Dr Andreas Laabs, CEO of LR Health & Beauty, pointed out. “I’m delighted that the renowned jury has acknowledged our ‘All-rounders’ user-friendlines
Kioxia Commences Operation of Two New R&D Facilities1.6.2023 09:00:00 EEST | Press release
Kioxia Corporation today commenced operation of two new R&D facilities — the Flagship Building at the Yokohama Technology Campus and the Shin-Koyasu Technology Front — strengthening the company’s research and development capabilities in flash memory and solid-state drives (SSDs). Going forward, other R&D functions in Kanagawa Prefecture will be relocated to these new R&D hubs to improve research efficiency and promote further advancement in technological innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230531006054/en/ Flagship Building at Yokohama Technology Campus (Photo: Business Wire) With the addition of the new Flagship Building, the Yokohama Technology Campus will almost double in size, allowing Kioxia to expand its capabilities in evaluating flash memory and SSD products, thereby enhancing overall product development and product quality. Equipped with environmentally-friendly facilities, the Flagship Buildi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom