VALBIOTIS
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) (Paris:ALVAL), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces that it has completed the recruitment of 600 volunteers for the international multicenter Phase II/III REVERSE-IT clinical study on TOTUM•63.
This randomized, placebo-controlled study evaluates the efficacy of TOTUM•63, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The primary objective will be the reduction of fasting blood glucose levels after 24 weeks of TOTUM•63 supplementation compared to placebo. The results will be communicated at the end of the study.
The Phase II/III REVERSE-IT study was co-designed by the Valbiotis and Nestlé Health Science medical and regulatory teams to demonstrate the efficacy of TOTUM•63 against prediabetes and untreated type 2 diabetes (early stage), as part of the global strategic partnership between the two companies. REVERSE-IT should confirm the positive results of the Phase II clinical study already obtained in a similar population with TOTUM•63.
Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs and member of the Valbiotis Board of Directors, commented: “We have reached a very important milestone in the development of TOTUM•63 with the completion of enrollment in the Phase II/III REVERSE-IT study . With 600 volunteers enrolled in more than 50 centers worldwide, REVERSE-IT is among the most ambitious studies of early dysglycemia, from prediabetes to early-stage type 2 diabetes, using non-drug approaches. We would like to thank all the teams involved in this project, as well as our partner Nestlé Health Science . With a highly demanding design, REVERSE-IT was developed to provide comprehensive and robust efficacy data on these populations in preparation for the TOTUM•63 market launch.”
The randomized, double-blind, placebo-controlled Phase II/III REVERSE-IT study includes 600 people with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). It should confirm the efficacy of TOTUM•63 at a dose of 5 g/day (3 daily intakes) for 24 weeks on blood glucose abnormalities and other metabolic risk factors for type 2 diabetes, compared to a placebo. The protocol will evaluate the effect of TOTUM•63 on fasting blood glucose, the primary endpoint of the study, as well as on a number of secondary endpoints of interest, including two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat mass).
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 health claim 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
Ticker symbol: 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 May 19, 2022. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220727005561/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
Core42 “Maximus-384” Cluster Secures Top 20 Ranking on the Global TOP500 Supercomputers List18.11.2025 14:24:00 CET | Press release
Core42, A G42 Company, secures #20 position with its AMD Instinct MI300X GPU cluster in Buffalo, New York.Results announced ahead of Supercomputing 2025.Collaboration between Core42, Broadcom and Arista Networks delivers a top performing and reliable HPC network with fast data transfers and minimal latency. Core42, a G42 company specializing in sovereign cloud and AI infrastructure, announced that itsMaximus-384 supercomputer has been ranked No. 20 globally on the TOP500 List, the industry’s most recognized benchmark for publicly known supercomputing systems. The ranking highlights the performance of the AMD Instinct™ MI300X GPU-based “Maximus” cluster, operated at the company’s facility in Buffalo, New York and released ahead of Supercomputing 2025, the leading global conference for HPC. The TOP500 list tracks performance trends across the global supercomputing systems using the High Performance Linpack benchmark (HPL) benchmark. Securing a top-20 position reflects exceptional enginee
Armis Streamlines Network and Security Operations by Utilizing Keysight’s Application Fusion Platform18.11.2025 14:00:00 CET | Press release
Armis' technology can now run on the Keysight Vision E1S network packet brokers using the open interface known as Application Fusion, empowering security teams to enhance efficiency, reduce infrastructure costs and strengthen their security posture Armis, the cyber exposure management & security company, and Keysight Technologies, Inc. (NYSE: KEYS) today announced that Armis’ cyber exposure management technology will now run directly on the Keysight Vision E1S network packet brokers, with additional models expected to support Application Fusion in the future. Through the Application Fusion interface, Armis’ technology can now run directly on the Keysight network packet brokers, combining network visibility with continuous cyber exposure management and security capabilities. By providing immediate, actionable insights across the entire network, without the need for additional hardware, security teams can respond to threats faster, proactively reduce risk and increase operational efficie
Parse Biosciences Announces FFPE-compatible Barcoding Technology for Whole Transcriptome Single Cell Analysis18.11.2025 14:00:00 CET | Press release
New method enables single cell discovery from archived tissue samples, expanding access to translational and clinical research Parse Biosciences, the leading provider of scalable and accessible single cell sequencing solutions, today announced a breakthrough technology that unlocks the full potential of formalin-fixed, paraffin-embedded (FFPE) samples. By enabling whole transcriptome capture from archived tissues at single cell resolution, this innovation opens new possibilities for discovery in oncology, translational research, and precision medicine. The use of FFPE samples for single cell RNA sequencing (scRNA-seq) has traditionally been limited to profiling a predefined list of genes due to RNA degradation and fragmentation, reducing transcriptome coverage and discovery potential. Parse’s breakthrough overcomes these challenges with a novel split-pool combinatorial barcoding method that enables true transcriptome-wide scRNA-seq of FFPE-preserved tissues through its unique RNA captu
KP Labs and Frontgrade Gaisler Join Forces to Advance Fault-Tolerant Computing for Next-Generation Space Missions18.11.2025 14:00:00 CET | Press release
KP Labs, a European Leader in delivering autonomous systems for space applications and Frontgrade™ Gaisler Technologies, a leading provider of high-reliability electronic solutions for space and national security missions have signed a Memorandum of Understanding during the Space Tech Expo Europe in Bremen, Germany. The agreement establishes a framework for collaboration in developing and validating advanced on-board computing architectures designed to increase the autonomy and resilience of future space missions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118359687/en/ As satellite operators and mission designers increasingly rely on on-board data processing and autonomy, maintaining fault tolerance and reliability has become a critical priority. To meet these demands, modern spacecraft integrates radiation-hardened components and advanced FDIR (Fault Detection, Isolation and Recovery) systems that ensure stable oper
ACE Fiber uses Adtran’s Mosaic One Clarity AI solution for proactive assurance, faster resolution and fewer truck rolls18.11.2025 14:00:00 CET | Press release
News summary: Mississippi provider’s fiber expansion increased operational complexity, driving the need for quicker troubleshooting and fewer site visits With Adtran’s Mosaic One Clarity, built on its REAL AI platform, ACE Fiber is transforming operations to prevent issues and reduce costs Early results show up to 75% fewer tickets in the first month, cutting service calls and improving customer experiences Adtran today announced that ACE Fiber, the broadband subsidiary of Mississippi’s ACE Power, is using its Mosaic One Clarity solution, built on the REAL AI platform, to move from reactive troubleshooting to proactive assurance across ACE Fiber’s expanding network. Mosaic One Clarity consolidates network and in-home data, identifies likely root causes and provides guided actions that help teams resolve issues faster and avoid unnecessary site visits. By detecting early signs of fiber performance issues and showing which subscribers are affected, Mosaic One Clarity enables more right-f
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