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
Suzano Reports 36% Increase in Third Quarter Net Revenue Following Consolidation of Arbex6.11.2026 00:23:00 CET | Press release
Suzano (B3: SUZB3 / NYSE: SUZ) , the world’s largest pulp producer, announces its results for the third quarter of 2026 (3Q26), which for the first time include Arbex, the joint venture between Suzano and Kimberly-Clark established in July this year. Driven primarily by the consolidation of Arbex’s contribution, Suzano reported net revenue of BRL16.5 billion, an increase of 36% on the same period last year and a new quarterly record in the company’s 102-year history. Adjusted EBITDA totaled R$5.7 billion in 3Q26, up 9% on the same basis of comparison. Operating cash generation reached R$3.8 billion, an increase of 12%. Net income totaled R$2.1 billion. As announced following the completion of the transaction with Kimberly-Clark, Suzano holds a 51% equity interest in Arbex and will therefore fully consolidate the joint venture’s financial statements from this quarter onwards.1 “This quarter marks the beginning of a new phase for Suzano. With Arbex, we are now a broader business, both ge
Andersen Consulting styrker sine transformationskompetencer med Bakia Consulting5.11.2026 23:12:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for forretningstransformation gennem en samarbejdsaftale med Bakia Consulting, et firma, der har specialiseret sig i transformation af økonomifunktionen. Bakia Consulting har hovedkontor i Paris og kapacitet i Singapore og Hongkong og har hjulpet store virksomheder og finansielle institutioner med at gentænke deres økonomifunktioner, herunder driftsmodeller, organisationsstrukturer, processer og digitale systemer. Bakia Consulting kombinerer projektledelse og forandringsledelse og arbejder tæt sammen med kunderne om at udvikle løsninger og fastholde forandringer. Virksomheden rådgiver også om modeller for økonomisk og ikke-økonomisk styring, procesoptimering og digitale værktøjer. "Økonomifunktioner forventes at levere bedre indsigt, arbejde mere effektivt og tilpasse sig skiftende forretningsbehov – ofte samtidig," udtalte Romain Dubuisson, partner hos Bakia Consulting. "Vi arbejder tæt sammen med vores kunder om at udvikle løsninger,
iQmetrix Unveils Built-In Intelligence for Every Role in Telecom Commerce at Its 2026 Telecom Industry Address5.11.2026 22:39:00 CET | Press release
An all-new AI inventory agent, iQ Hub and iQ Pay for Back Office bring intelligence to every role. iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, last week shared highlights from its 2026 Telecom Industry Address and Product Announcements, held virtually on Oct. 28 in two sessions, one for North American audiences and one for European audiences. The address was built around one theme: intelligence. Telecom commerce is moving from systems that record the business to systems that act on it, and the announcements put that intelligence in the hands of every role, from the sales associate at the counter, to the finance manager in the back office, to the corporate view leading the channel experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261105003162/en/ "Right now telecom providers are competing in a race to the bottom on price that no one wins. The way out is intelligence. Not AI bo
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.11.2026 22:30:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to nine newly hired non-executive employees. The equity awards were granted on November 2, 2026, and consisted of options to purchase an aggregate of 59,275 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 28,200 shares. These options have an exercise price per share equal to $8.41, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted s
Graco QUANTM i230 Brings Electrification to High-Flow Fluid-Transfer Applications5.11.2026 22:16:00 CET | Press release
New electric 3-inch double-diaphragm pump helps paint, coatings and ceramics manufacturers increase throughput while reducing energy consumption by up to 80%. Graco Inc. is helping manufacturers electrify high-flow fluid-transfer applications with the global launch of the 3-inch QUANTM® i230, bringing efficient electric drive technology to demanding processes that have traditionally relied on pneumatic pumps. Paint, coatings and ceramics manufacturers depend on diaphragm pumps for their flexibility, reliability and ability to handle challenging materials. But pneumatic pumps also depend on compressed air — an energy-intensive plant resource whose available capacity can fluctuate as demand changes across a facility. The QUANTM i230 gives manufacturers another option for qualified high-flow applications. By combining familiar diaphragm pump capabilities with electric operation, the pump helps manufacturers move more material, reduce transfer bottlenecks and lower energy consumption by up
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