VALBIOTIS
28.6.2021 17:42:11 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 diseases, announces the implementation of the TOTUM•63 mode of action clinical study by the Institute of nutrition and functional foods (INAF) at Laval University in Quebec City, in partnership with Nestlé Health Science.
This study, co-designed by Valbiotis in conjunction with INAF and Nestlé Health Science experts 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 strengthen the scientific communication and support the commercialization of TOTUM•63. Scheduled to begin in the 4th quarter of 2021, it will be conducted under the scientific supervision of André MARETTE, Professor at the Laval University Faculty of Medicine and researcher at INAF.
Murielle CAZAUBIEL, Chief Medical, Regulatory and Industrial Affairs Officer at Valbiotis, member of the Board of Directors, comments: "This very ambitious study will explore the mode of action of TOTUM•63, a multitarget active substance, in humans. It is the result of a high level of collective work with experts from INAF and Nestlé Health Science, whom we would like to thank for their commitment to this process. INAF is a key player in nutrition and metabolic sciences in North America, particularly in Canada, a country leading the way in the regulation of natural health products. This collaboration is an undeniable asset for the completion of TOTUM•63 development under the global strategic partnership with Nestlé Health Science. And this affiliation with the Canadian scientific ecosystem reflects our commitment to develop R&D activities in North America, the epicenter of global research and a leading commercial market in the field of metabolic diseases."
The TOTUM•63 mode of action clinical study will explore, in humans, the main mode of action hypotheses resulting from preclinical work. It will include 20 overweight or obese volunteers with associated metabolic abnormalities. With a large number of scientific objectives, the protocol will evaluate the effect of TOTUM•63 administration for 8 weeks on numerous mechanistic parameters involved in the pathophysiology of prediabetes and type 2 diabetes, through in-depth physiological investigations: mainly intestinal absorption of nutrients, metabolomics, inflammation, composition of the intestinal microbiota and gastrointestinal hormones (incretins, including GLP-1).
Prof. André MARETTE, Professor at the Laval University Faculty of Medicine (Quebec City) and researcher at INAF, and scientific advisor of the study comments: "This scientific collaboration between our two organizations makes perfect sense, as Valbiotis' approach is fully in line with INAF's research. As a member of Valbiotis' Scientific and Medical Board for the past 4 years, I am well aware of the relevance of their R&D in the field of metabolic disease and I am convinced of the multitarget approach of its active substances. This is what we will explore in humans, with this study on the mode of action of TOTUM•63. With the collaboration of Prof. Marie-Claude VOHL, expert in genomics applied to nutrition and metabolic health, we will be able to identify the mechanisms of action of TOTUM•63 on subjects with overweight or obesity associated with metabolic abnormalities, including metabolomic and (meta)genomic signatures related to expected metabolic health effects such as inflammation and gastrointestinal functions.We at INAF look forward to bringing our expertise and our investigative resources to the service of this exciting project."
The study, designed to boost the scientific and commercial value of TOTUM•63, is part of the development plan established with Nestlé Health Science under the global strategic partnership for TOTUM•63. It will be the subject of milestone payments, dedicated in particular to its financing. Its launch is planned for the fourth quarter of 2021.
To support this scientific collaboration and the development of Valbiotis' R&D activities in North America, the Company is opening a subsidiary, with a full-time employee responsible for scientific coordination starting in September. The research project carried out under this collaboration will be eligible for the Canadian Scientific Research and Experimental Development (SR&ED) program (system equivalent to the French research tax credit).
About INAF
Created in the early 2000s to address the challenges of sustainable nutrition and the prevention of metabolic diseases, INAF brings together some 100 researchers in bio-food, health and social sciences from 14 universities and scientific institutions in Québec. 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 the treatment and prevention of metabolic 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, based on a multi-target approach enabled by the use of plant-based ingredients.
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 the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and uncertainties, including those described in the Valbiotis registration document, filed with the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018). This document is available on the Company's website (www.valbiotis.com
).
This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, Valbiotis' shares or securities in any country.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210628005485/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
Andersen Consulting tilføjer samarbejdspartneren Milestone Technologies19.3.2026 19:02:00 CET | Pressemeddelelse
Andersen Consulting fortsætter med at styrke sin platform for digital transformation med tilføjelsen af samarbejdspartneren Milestone Technologies, der er en veletableret global leverandør af it-services og digitale løsninger med base i USA. Milestone Technologies blev grundlagt i 1997 og leverer omfattende teknologi- og outsourcingløsninger, der spænder over digitale arbejdspladstjenester, cloud- og infrastrukturstyring, data, AI og automatisering, apps og digital engineering, business process outsourcing samt implementering af platforme som ServiceNow og Salesforce. Med hovedkontor i Fremont, Californien, opererer Milestone i 35 lande på globalt plan og samarbejder med nogle af verdens største virksomheder. Virksomhedens integrerede leveringsmodel gør det muligt for kunder at transformere deres it-drift, øge serviceeffektiviteten og skalere teknologiske økosystemer gnidningsfrit over hele verden. "Milestone Technologies er en medarbejderfokuseret organisation, der leverer målbare for
Klarna Card reaches 5 million active customers19.3.2026 15:31:00 CET | Press release
Klarna, the global digital bank and payments provider, today announced that the Klarna Card has reached 5 million active customers globally, underscoring rapid adoption as consumers shift towards new forms of payment which provide more control over day-to-day money management. The card draws from the customer's own funds for everyday spending, with the option to spread the cost of a specific purchase, like a large appliance or a flight, when it makes sense to do so. The result is a card that offers genuine spending control without the long-term debt obligations that come with traditional credit cards. The card’s growth is reinforced by Klarna’s membership program. The program offers premium perks such as airport lounge access, travel insurance, and lifestyle subscriptions — without requiring users to take on debt, meet spending thresholds, or revolve balances. By separating everyday spending from rewards, Klarna is challenging the strings-attached model legacy banks have long relied on
Stonebranch Releases 2026 Global State of IT Automation Report, Revealing Orchestration as the Missing Link for AI Adoption and Trust19.3.2026 14:30:00 CET | Press release
New research shows hybrid IT orchestration, automation-as-a-service, and WLA investments are accelerating as AI workflow deployment scales across the enterprise. Stonebranch, a leading provider of service orchestration and automation solutions, today released its annual 2026 Global State of IT Automation Report, the company’s most comprehensive research study to date. Based on responses from 402 IT automation professionals spanning C-suite executives to individual contributors across North America, EMEA, Latin America, and APAC, the report provides a detailed, data-driven portrait of how enterprises are investing in, deploying, and deriving value from IT automation in 2026. “This year’s findings highlight an important shift in how organizations approach automation,” said Giuseppe Damiani, CEO of Stonebranch. “Organizations are now building automation as strategic infrastructure — a governed, scalable foundation that spans hybrid environments, operationalizes AI, and delivers automation
Perma-Pipe Accelerates Growth with New U.S. Northeast Facility Investment to serve Artificial Intelligence Data Center customers, Provides Middle East Operations’ Update and Concludes the Board’s Review of Strategic Alternatives19.3.2026 14:00:00 CET | Press release
Perma-Pipe International Holdings, Inc. (the “Company”) today announced a strategic expansion initiative focused on accelerating growth through entry into the high-demand U.S. Northeast region. The Company is positioning itself to capitalize on the rapidly expanding Artificial Intelligence (“AI”)-driven data center market in both the United States and international markets while continuing to reinforce its leadership in critical infrastructure solutions. As part of this growth strategy, Perma-Pipe will prioritize investments aimed at expanding its presence in the rapidly evolving AI data center sector. The initiative reflects the Company’s long-term commitment to supporting next-generation technology infrastructure and strengthening its position in the global energy, industrial, and infrastructure markets. Expansion in the U.S. Northeast President & Chief Executive Officer, Saleh Sagr said, “We are excited to announce the expansion of our operations with a new facility in the Northeast
Armis Launches First-of-Its-Kind Benchmark Report Warning of Critical Security Gaps in AI-Native Development19.3.2026 13:00:00 CET | Press release
Research reveals 100% of leading generative AI models fail to generate secure code for critical development scenarios Armis, the cyber exposure management & security company, is warning that the rapid enterprise adoption of AI-native development is outpacing critical security safeguards, leaving organizations exposed to systemic vulnerabilities. New research from Armis Labs’ Trusted Vibing Benchmark Report, which evaluates 18 leading generative AI models across 31 test scenarios, reveals a 100% failure rate in generating secure code. These vulnerabilities are most prevalent in high-risk areas like memory buffer overflows, design file uploads and authentication systems. Therefore, organizations should immediately implement AI-native application security controls to reduce risk. “The era of vibe coding is here, but speed should not come at the cost of security,” said Nadir Izrael, CTO and Co-Founder of Armis. “Our research finds that the worst offenders are the same ones selling security
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