VALBIOTIS
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
Access Advance Welcomes Global Technology Leaders as Licensees and Licensors to New Video Distribution Patent Pool2.7.2025 02:00:00 CEST | Press release
Access Advance LLC ("Advance") today announced the inaugural roster of licensees and licensors for its Video Distribution Patent ("VDP") Pool, marking a significant milestone in the program's rapid market adoption since its January announcement. The participation of major global companies heavily involved in video codec technology demonstrates strong industry support for the comprehensive licensing solution covering HEVC, VVC, VP9, and AV1 codecs. The VDP Pool has successfully attracted a group of licensees/licensors including ByteDance, Kuaishou, NTT Docomo, and Tencent. This represents the beginning of what Access Advance expects to be widespread adoption among content streaming providers seeking simplified codec licensing. The licensees’ participation provides immediate access to the wide-ranging patent portfolio while benefiting from the fixed tiered pricing structure designed to scale with business size. "We're pleased to welcome ByteDance, Kuaishou, NTT Docomo and Tencent as our
Intralot S.A. to Acquire Bally’s International Interactive Business in a Transaction that Creates a Global Gaming Technology and Services Company in Lottery and Digital Online Gaming Markets1.7.2025 21:10:00 CEST | Press release
Intralot S.A. to Remain Listed on the Athens Stock ExchangeTransaction Enterprise Value of €2.7 Billion Intralot S.A. (ATSE: INLOT) (“Intralot”) and Bally’s Corporation (NYSE: BALY) (“Bally’s”) today announced that their respective Boards of Directors approved their entry into a definitive transaction agreement (“Transaction Agreement”) pursuant to which Intralot will acquire Bally’s International Interactive business (the “International Interactive Business”) in a cash-and-shares transaction that values the International Interactive Business at an enterprise value of €2.7 billion (the “Transaction”). The consideration for the acquisition of the International Interactive Business will comprise a combination of cash paid by Intralot and newly issued shares delivered by Intralot to Bally’s, as more specifically detailed below. As part of the Transaction, Intralot expects to refinance part of its existing debt facilities and Bally’s also expects to repay secured debt from the cash proceed
Valeo Foods Group Acquires Melegatti Cakes Expanding the Italian Bakery Portfolio1.7.2025 18:21:00 CEST | Press release
Valeo Foods Group, one of Europe’s leading producers of quality sweets, treats and snacks, has successfully acquired the assets of an Italian panettone, pandoro and croissant producer, Melegatti 1894 S.p.A.This acquisition is another step forward in Valeo Foods Groups’ strategy to expand its baked sweet treats portfolio, and reinforces Valeo’s commitment to bringing authentic Italian confections and established regional brands to a wider international audience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702677156/en/ Melegatti Founded in 1894 in Verona, Melegatti has a strong reputation for artisanal cakes - particularly pandoro, panettone and filled croissants - traditional recipes, and a rich Italian heritage, Melegatti has a proud legacy founded on family values, craftsmanship, and a passion for quality. “We are excited to welcome Melegatti into the Valeo Foods Group,” said Ronald Kers, Group CEO. “This acquisition
PUMA and Borussia Dortmund Extend Partnership1.7.2025 18:18:00 CEST | Press release
Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701775493/en/ Sports company PUMA has extended its long-standing partnership with Borussia Dortmund, and will continue to create products that cater to BVB’s many passionate fans around the world and match the club’s dynamic, fast paced style of football. Since the start of their partnership in the 2012/13 season, BVB has celebrated many successes, such as reaching the finals of the 2012/13 and 2023/24 UEFA Champions League and winning the 2016/17 and 2020/21 German DFB Cup. The club is currently participating in the FIFA Club World Cup, where it has already reached the round of 16. BVB continues to set the standard in European football w
Gogo Galileo HDX Coming to Cessna Citation Jet Models1.7.2025 17:00:00 CEST | Press release
Expected FAA Supplemental Type Certification in late 2025 Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. The global Low Earth Orbit (LEO) solution allows customers to enjoy one of the best possible in-flight connectivity and aviation experiences, no matter where their journey takes them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701750049/en/ Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced Gogo Galileo HDX will be available for aftermarket installation on Cessna Citation jets after Federal Aviation Administration (FAA) Supplemental Type Certification (STC) expected in late 2025. (Photo: Textron Aviation) By offering Gogo Galileo HDX as an aftermarket upgrade, the Textron Av
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