Valbiotis Announces the First Visit of the First Patient in the TOTUM•63 Mode of Action Clinical Study Conducted by the INAF1, in Partnership With Nestlé Health Science
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the first visit of the first patient in the TOTUM•63 mode of action clinical study conducted by the Laval University Institute of Nutrition and Functional Foods (INAF) in Quebec City, in partnership with Nestlé Health Science. The study has now been launched, after receiving approval from Health Canada and the CERUL2.
This study, co-designed by Valbiotis in consultation with experts from the INAF and Nestlé Health Science as part of the global strategic partnership, will include 20 volunteers and will explore the mechanism of action of TOTUM•63 in humans. It will provide additional data to support scientific communication on TOTUM•63 and accompany its commercialization. It will be scientifically supervised by André MARETTE and Marie-Claude VOHL, professors at the Laval University Faculty of Medicine and researchers at the INAF.
Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs, member of the Valbiotis Board of Directors, comments: "This exploratory mode of action study will identify the mechanisms of action of TOTUM•63 in overweight or obese subjects with metabolic disturbances. These data will complement the efficacy data from the pivotal Phase II/III REVERSE-IT clinical trial, which is currently underway. We are excited to enter this final push into the prediabetes market and thank the INAF and our partner Nestlé Health Science for their involvement right alongside us."
The TOTUM•63 clinical mode of action study will explore the main hypotheses of the mode of action in humans established thanks to the results of preclinical work. It will include 20 volunteers who are overweight or obese with metabolic abnormalities. With a large number of scientific objectives, the protocol will evaluate the effect of TOTUM•63 administration for 8 weeks on several of the mechanistic parameters involved in the pathophysiology of prediabetes and type 2 diabetes, using in-depth physiological explorations: mainly intestinal nutrient absorption, metabolomics, inflammation, gut microbiota composition and gastrointestinal hormones (incretins, including GLP-1).
As part of the global strategic partnership on TOTUM•63, today's announcement of the first visit of the first patient is a milestone that results in a new lump-sum payment from Nestlé Health Science to Valbiotis, to be received in the first half of 2022.
Sébastien PELTIER, CEO and Chairman of the Board of Directors, adds: "2022 will be a decisive year in the acceleration of our clinical calendar with important results expected in our main indications. Today, in the field of prediabetes, we are reaching a new milestone that materializes the strength of the project built with our partner Nestlé Health Science. Together, we are moving forward on the roadmap that will lead us to the future launch of a product with proven scientific value that will support its potential for commercialization around the world. This also marks an opportunity to benefit from a new milestone payment that further strengthens our financial position as we pursue our ambitious strategic market plan."
Created in the early 2000s to address the challenges of sustainable nutrition and the prevention of metabolic diseases, the INAF brings together some 100 researchers in the biofood, health and social sciences sectors from 14 universities and scientific institutions in Quebec. Its multidisciplinary approach and the quality of the projects it coordinates have earned it a reputation for scientific excellence on the North American continent.
TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.
TOTUM•63 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•63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes. In these subjects, who were also abdominally obese, TOTUM•63 also significantly reduced body weight and waist circumference.
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 and national phases are still underway in a dozen other countries including Brazil and Australia. 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 worldwide 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 Research & Development company committed to scientific innovation for preventing 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 diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Its products are intended to be licensed to players in the health sector.
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 also been awarded "Young Innovative Company" 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.
For more information about Valbiotis, please visit: www.valbiotis.com
ISIN code: FR0013254851
Mnemonic code: 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 approved by the French Financial Markets Regulator (AMF) on July 27, 2021 (application number R 21-039). 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.
1Institute of Nutrition and Functional Foods (INAF)
2Health Sciences Sectoral Committee of the Laval University Ethics Committee for Research with human subjects
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Corporate communication / Valbiotis
Carole ROCHER / Marc DELAUNAY
+33 5 46 28 62 58
Media relations / PrPa
+33 6 80 28 47 70
Financial communiation / 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
PwC Belgium and BR-AG Collaborate on Agile Platform to Unlock Value Behind Regulatory Reporting18.5.2022 11:03:00 EEST | Press release
As regulatory reporting requirements become more complex and regulators become more demanding on the data quality, financial institutions must deal with time-consuming regulatory reporting processes and manage the associated risks. Tapping into this challenge, PwC Belgium, with the support of technology-collaborator BR-AG, developed Regulatory Reporting Insights, powered by BR-AG’s ATOME Matter and ATOME Particles solutions. “I am excited about the opportunities this improved collaboration with our trusted technology partner BR-AG will bring. This allows financial institutions not only immediate access to an increased level of trust in their regulatory reporting but also to unlock the insights their regulatory reporting contains that was previously only accessible to supervisors.” Jeroen Bockaert, Partner and Product & Services Leader at PwC Belgium “It is truly inspiring that our collaboration with PwC has coined into developing this cutting-edge, data-driven tool. As technology exper
FourKites Hires Supply Chain Veteran in Europe, Underscoring Significant Growth in International Ocean Visibility18.5.2022 11:00:00 EEST | Press release
Philippe Salles has been appointed FourKites’ Vice President of Strategic Solutions (Ocean), bringing a wealth of experience to this booming area of the company’s business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220518005080/en/ Philippe Salles has been appointed FourKites’ Vice President of Strategic Solutions (Ocean). (Photo: Business Wire) “I’m delighted to be joining FourKites,” says Philippe, who brings experience from CMA CGM, INTTRA and maritime research and consultancy firm Drewry. “Visibility has been ocean shippers’ top priority for decades, and today’s real-time visibility platforms have completely changed the game. In addition to its market-leading machine learning-driven platform, FourKites understands that industry mindset and professionalism are as important as the technology itself. We need to provide shippers with a long-term strategic vision for their supply chain to make them resilient and collabor
Virtual Exhibitions of 23 Museums Lands on the Alipay Platform to Enhance Engagement with Mobile-Savvy Audience18.5.2022 10:46:00 EEST | Press release
On International Museum Day 2022, 4DAGE announced it landed virtual tours and exhibitions of 23 museums, including the historic Henan Museum and Zhejiang Provincial Museum in China and the Hetjens Museum in Germany, through a mini program on Alipay, the leading digital open platform. The collaboration between 4DAGE and Alipay provides China’s mobile-savvy audience an opportunity to better engage with and learn about the museums’ rich histories. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220518005528/en/ A large bronze mask from China’s “Sanxingdui Ruins” displayed in the Sichuan Museum’s Bronze Age exhibition; from the virtual tour on the Alipay platform (Photo: Business Wire) The mini program “Yunshang Mibao” (translated as “treasure hunting on the cloud”) launched on the Alipay platform provides users an immersive museum-visiting experience at their fingertips. They can appreciate the beauty of cultural relics in 3D an
REPLY – Digital Experience Is Recognised as No. 1 Internet Agency and Company Group for the Fourth Year in a Row by BVDW18.5.2022 10:30:00 EEST | Press release
As done in the previous three years, the Bundesverband Digitale Wirtschaft (BVDW) honours Reply – Digital Experience once again as the top company in their ranking of Internet Agencies for 2022. This recognition shows Reply – Digital Experience’s capability to offer technical solutions in conjuction with creative agency services and the right customer experience strategies. In addition, Reply – Digital Experience saw an increase in sales and their staff in the past financial year as a result of both continuous organic growth and the acquisition of Comwrap, a company headquartered in Frankfurt, specialised in cloud-based digital experience platforms. “To implement a holistic digital experience strategy it is essential to have the interplay of marketing and technology, outstanding creative ideas and a deep understanding of user needs. This involves the use of technology stacks and concepts such as artificial intelligence, virtual and augmented reality, data-driven marketing and conversat
Metanomic Acquires Intoolab, Developers of the First Bayesian Network Artificial Intelligence Engine18.5.2022 10:30:00 EEST | Press release
Today, Metanomic (https://www.metanomic.net/) announces it has acquired Intoolab A.I (https://www.intoolab.com/) , a Bayesian Network Artificial Intelligence company, to expand and to improve data analysis and A.I across video games and Web3. This acquisition augments Metanomic’s current game economy infrastructure that allows developers to build, simulate and run balanced game economies and core gameplay loops in a live, real-time environment. The addition of artificial intelligence helps developers create better experiences through intelligent insight from player behaviour in run-time. As a part of the acquisition the existing solution will be rebranded to Thunderstruck and extend the capabilities of the Metanomic Engine. A more intelligent approach to video game development and Web3 analytics Thunderstruck is based on a new approach to artificial intelligence that is not based on off the shelf machine learning algorithms but a powerful combination of Deep Learning and Dynamic Bayesi
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