VALBIOTIS
28.4.2022 17:42:10 CEST | Business Wire | Press release
Regulatory News:
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. "
About INAF
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.
About TOTUM•63
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.
About Valbiotis
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
Name: Valbiotis
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.
1
Institute of Nutrition and Functional Foods (INAF)
2
Health Sciences Sectoral Committee of the Laval University Ethics Committee for Research with human subjects
View source version on businesswire.com: https://www.businesswire.com/news/home/20220428005577/en/
Link:
About Business Wire
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
Fortegra Appoints Guy House as SVP, Treaty Reinsurance27.10.2026 10:00:00 CET | Press release
The Fortegra Group, Inc. ("Fortegra" or the "Company"), a global specialty insurer and part of DB Insurance Co., Ltd., has appointed Guy House as Senior Vice President, Treaty Reinsurance. In this role, he will lead Fortegra’s treaty reinsurance underwriting strategy from the Company’s UK office. Mr. House brings more than 18 years of London market experience. He has written and bought reinsurance across multiple product lines and tiers, including property, marine, energy, terrorism and aviation. His expertise spans treaty and retrocession reinsurance, direct and facultative (D&F) insurance, exposure management, alongside capital raising and management. Previously, Mr. House was Head of Property at Tamesis Dual, having joined from Markel International where he worked as the Senior Property D&F Underwriter. He is ACII qualified and holds a degree in Economics from Durham University. About Fortegra For more than 45 years, Fortegra, via its subsidiaries, has underwritten risk management s
TetraMem Advances Analog In-Memory Computing with Tapeout of New 12nm AI SoC27.10.2026 09:41:00 CET | Press release
Leveraging Synopsys cloud-enabled EDA solutions to scale multi-level RRAM-based AI chip development to advanced FinFET nodes TetraMem, a Silicon Valley-based pioneer in analog in-memory computing (A-IMC), announced the successful tapeout of MLX300, the world’s first 12nm A-IMC system-on-chip (SoC) based on multi-level RRAM technology. The SoC was developed using industry-leading EDA solutions enabled through Synopsys Cloud FlexEDA, and this milestone represents a major step in bringing this architecture toward advanced-node, production-ready computing. “TetraMem’s architecture represents a fundamentally new approach to AI computing by converging memory and compute together,” said Glenn Ge, CEO and Co-founder of TetraMem. “Leveraging Synopsys EDA solutions through Synopsys Cloud have been instrumental in enabling efficient global collaboration and accelerating our path from research innovation to manufacturable silicon.” The MLX300 tapeout follows TetraMem’s recently announced MLX200/ML
Exeon Analytics Introduces AgentGuard for Visibility and Threat Detection Across AI Use and Agent Activity27.10.2026 09:30:00 CET | Press release
Exeon.AgentGuard helps organizations identify approved and shadow AI use, investigate potential data leakage and detect unusual activity across AI agents, applications, tools and external resources. Exeon Analytics today introduced Exeon.AgentGuard, a new AI security solution designed to give organizations visibility into approved and shadow AI use, autonomous agent activity and the data flows created through connected tools and external services. Building on its expertise in AI-driven behavioral analytics and threat detection, Exeon expands its cybersecurity capabilities to address emerging risks associated with the rapid adoption of agentic AI. Bringing visibility, addressing data leakage and rogue AI agent behavior As enterprises increasingly adopt AI agents, maintaining visibility into their activities becomes critical. Whether operating autonomously or on behalf of employees, organizations need to understand what AI agents are doing, which systems and data they access, and how the
Former Nokia Technologies C-suite Executive Joins Sisvel to Lead Creation of New Ventures Unit27.10.2026 09:04:00 CET | Press release
Stavros Kyris has joined Sisvel to lead the formation of Sisvel Ventures, which has a wide-ranging remit to explore opportunities outside of Sisvel’s core areas of business. Kyris previously held a number of senior roles at Nokia and from 2019 until earlier this year was Chief Strategy, Financial and Operating Officer of Nokia Technologies. Before that, he spent five years as Chief of Staff to Nokia’s CEO, having formerly worked in corporate business development, strategy and M&A at the company. Sisvel Ventures will identify and develop IP-based business projects that do not sit within Sisvel’s established standard essential patent (SEP) pool licensing operation. It will draw on expertise within the broader company while functioning separately from it. Senior Sisvel executives Matteo Sabattini and Leonardo Saroni will join Kyris in building the new unit. “Sisvel Ventures is an exciting endeavour that I am delighted to help launch,” says Kyris. “Sisvel has a reputation for its bold, ent
Ant Group Upgrades LingGuang to 2.0, Turning Its AI Assistant into a Proactive Personal Agent27.10.2026 09:00:00 CET | Press release
Ant Group today announced the launch of LingGuang 2.0, an upgrade that transforms its multimodal AI assistant into a proactive personal agent capable of identifying user needs and managing tasks over time. Moving beyond passive, single-turn interactions, LingGuang 2.0 shifts AI assistance from responding to commands toward continuously identifying needs, following up on tasks, and coordinating everyday affairs on behalf of users. Unlike conventional conversational AI and task-oriented agents, LingGuang 2.0 moves the starting point of AI assistance earlier in the user’s workflow. Instead of waiting for users to issue a command, LingGuang can, with explicit user authorization, draw on connected information and services to spot potential needs, initiate analysis and follow-ups, and alert users when their attention is required. In this way, it evolves from a reactive tool into a personal agent that continuously manages tasks on the user’s behalf. This shift is powered by comprehensive upgr
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