VALBIOTIS
15.7.2020 17:42:09 CEST | Business Wire | Press release
Regulatory News:
VALBIOTIS (Paris:ALVAL) (FR0013254851 - ALVAL, PEA/SME eligible) a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the First Patient First Visit in the international Phase II/III REVERSE-IT clinical study designed to assess TOTUM-63 for the reduction of Type 2 Diabetes metabolic risk factors.
Murielle CAZAUBIEL, member of the Management Board and Director of Development and Medical Affairs at VALBIOTIS, comments: "The first visit of this first subject, a few days after obtaining both ANSM1 approval and the favorable decision from the CPP2 , marks the concrete launch of the REVERSE-IT study, the results of which are expected in mid-2022. We are right on schedule and are delighted to be able to enter the operational phase of this major study so quickly. We also welcome the enthusiasm and commitment of all the partner investigation centers."
Dr Hans-Juergen WOERLE, Chief Scientific and Medical Officer at Nestlé Health Science, states: "The first visit of the first subject in the Phase II/III study is a great step forward for TOTUM-63 and encouraging news for patients with prediabetes or untreated early stage Type 2 diabetes. With the 600 patients in this global clinical study, the objective is to demonstrate efficacy and safety of a new plant-based extract.“
The pivotal, randomized, double-blind, placebo-controlled REVERSE-IT study will include 600 patients with fasting hyperglycemia ranging from prediabetes to untreated early stage Type 2 Diabetes. The study should confirm the efficacy of TOTUM-63 - at a dose of 5g/day for 6 months - in addressing the metabolic risk factors for developing Type 2 Diabetes, compared to placebo. The protocol will assess the effect of TOTUM-63 on fasting blood glucose, the primary endpoint of the study, as well as on two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat mass), all well-known risk factors for Type 2 diabetes.
REVERSE-IT is being conducted in more than 30 centers in France and internationally.
As a result of this achievement, VALBIOTIS will receive the first milestone payment of CHF 3 million from Nestlé Health Science. The global strategic partnership with Nestlé Health Science, concluded in February 2020, includes an upfront payment of CHF 5 million, already received by Valbiotis, development & sales milestone payments up to a maximum CHF 66 million and tiered royalties on net sales. The agreement also includes the supply of TOTUM-63 by VALBIOTIS to Nestlé Health Science, representing an additional source of revenue.
ABOUT THE REVERSE-IT STUDY
The international Phase II/III REVERSE-IT study is the final step in the clinical development of TOTUM-63, an innovative plant-derived active substance designed to reduce the risk factors for type 2 diabetes.
This randomized, double-blind, placebo-controlled study will involve 600 patients with impaired glucose metabolism ranging from prediabetes to untreated type 2 diabetes (early stage). The protocol calls for oral intake of TOTUM-63 at a dose of 5 g/day for 6 months, versus placebo.
The REVERSE-IT study is expected to confirm the efficacy of TOTUM-63 on the major risk factors for type 2 diabetes: fasting blood glucose elevation, the primary endpoint of the study, two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat).
REVERSE-IT is being conducted following the positive results of the TOTUM-63 Phase II clinical study, published in July and September 2019. It was co-designed with the medical and regulatory teams of Nestlé Health Science, as part of the global strategic partnership for the development and marketing of TOTUM-63, signed by the two companies in February 2020. It will be conducted in more than 30 clinical investigation centers in France and abroad.
ABOUT TOTUM-63
TOTUM-63 is a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of Type 2 Diabetes.
TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the international randomized, placebo-controlled Phase II study showed that TOTUM-63 reduced fasting and 2-hour blood sugar levels, two risk factors for Type 2 Diabetes, in prediabetics compared to placebo. In these subjects, who also had abdominal obesity, TOTUM-63 significantly reduced body weight and waist circumference.
TOTUM-63 benefits from intellectual property granted in the main markets worldwide: Europe (covering 39 countries), the United States, Russia and national phases are underway in more than 20 countries including China, Japan, Brazil, Australia. The ability to produce TOTUM-63 industrially, in compliance to North American and European standards, has been validated. TOTUM-63 already has marketing authorizations related to its status in Europe.
In 2020, VALBIOTIS has signed a global and long-term partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM-63. This unique partnership in the field of Nutrition Health plans that TOTUM-63 will be put on the market by Nestlé Health Science at a global level, possibly before obtaining a health claim, depending on the areas. It will also provide funding for the latest development stages of TOTUM-63.
ABOUT NESTLE HEALTH SCIENCE
Nestlé Health Science (NHSc), a wholly-owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. Headquartered in Switzerland, NHSc employs over 5,000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow.
For more information, please visit: www.nestlehealthscience.com
.
ABOUT VALBIOTIS
VALBIOTIS is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.
VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63).
VALBIOTIS is a member of the "BPI Excellence" network and received the "Innovative Company" status accorded by BPI France. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.
Find out more about VALBIOTIS: www.valbiotis.com
Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
DISCLAIMER
This press release contains forward-looking statements about VALBIOTIS' objectives, 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 can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 31 July 2019 (application number R19-030) as well in its supplement approved by the AMF on Octobre 9, 2019. These documents being 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.
1
ANSM: French National Agency for the Safety of Medicines and Health Products
2
CPP: French Research Ethics Committee
View source version on businesswire.com: https://www.businesswire.com/news/home/20200715005644/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
Sinopec Receives CSR Award at Sino-European ESG Conference in Germany1.7.2026 15:38:00 CEST | Press release
China Petroleum & Chemical Corp. (Sinopec) has received the Corporate Social Responsibility Best Practice Award at the 3rd Sino-European Corporate ESG Best Practice Conference in Mainz, Germany, for its case study on carbon footprint management and low-carbon development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701696760/en/ Huang Yiyang (L), Chinese Consul General in Frankfurt, presents the award to a representative of Sinopec. The conference jury said Sinopec has developed a carbon management framework centered on product carbon footprint management, covering the full product life cycle while aligning with both Chinese and European standards. It cited the company’s work with German chemical producer BASF to achieve mutual recognition of carbon footprint accounting methodologies as a milestone that could support greener cooperation across international industrial supply chains. According to the jury, Sinopec’s eff
Vercel and Mercedes-AMG PETRONAS Formula One Team Announce Multi-Year Strategic Partnership1.7.2026 15:30:00 CEST | Press release
The agentic infrastructure platform known for speed is joining forces with one of the world's fastest Formula One teams Today Vercel, the agentic infrastructure company, announced a new multi-year deal with the Mercedes-AMG PETRONAS Formula One Team. Starting with the British Grand Prix July 2 – 5 2026, Vercel branding will appear on the Mercedes-AMG PETRONAS Formula One Team race cars as the partnership begins its first chapter, before expanding significantly across the team ecosystem from 2027 onward. The partnership includes global branding rights, premium hospitality experiences, customer engagement, content creation, and technical collaborations, including plans to evolve the team’s digital platforms to Vercel. “Formula One is where every millisecond matters, every decision counts, and continuous innovation is fundamental to success. Vercel shares that same philosophy,” said Richard Sanders, Chief Commercial Officer, Mercedes-AMG PETRONAS Formula One Team. “The Vercel platform is
OXMIQ Raises $35 Million to Scale OxCore™ Architecture1.7.2026 15:15:00 CEST | Press release
OXMIQ Labs Inc., a unified GPU and AI architecture company founded by Raja Koduri, today closed its $35 million Series A financing, bringing the company’s total capital raised to $60 million. The funding will scale OxCore™, OXMIQ’s licensable GPU architecture that allows semiconductor companies and AI system builders to build custom AI silicon without a full chip program. The round was co-led by Fundomo and Samsung Catalyst Fund, with participation from MediaTek, AM Intelligence Labs, Pegatron Venture Capital, CDIB-TEN, Darwin Ventures, and Morgan Creek Digital, among other financial and strategic investors. OXMIQ’s expertise spans the full AI stack, from renewable power and data center infrastructure to silicon IP, electron-to-token machines (ETMs™), along with the software that runs AI factories and agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701241910/en/ OXMIQ Funding raised to date of $60M after current $3
SamanTree Medical’s Histolog® Scanner Technology Featured in 13 Publications in Special BJU International Issue on Confocal Microscopy in Urology1.7.2026 15:01:00 CEST | Press release
Papers highlight clinical research on use of confocal microscopy for real-time tissue assessment in various urologic procedures SamanTree Medical, a global leader in surgical imaging innovation, today announced that Histolog Scanner confocal microscopy technology has been featured in 13 peer-reviewed clinical papers in a special issue of BJU International, one of the world’s leading journals in urology. The special edition focuses on a growing body of evidence of the role of confocal microscopy in urologic surgery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701425845/en/ SamanTree Medical announces that Histolog® Scanner confocal microscopy technology is featured in 13 peer-reviewed clinical papers in a special issue of BJU International. “The special issue represents increasing momentum behind confocal microscopy in urologic surgery,” said Professor Greg Shaw, consultant urologic surgeon at University College London
Regnology to Acquire Fed Reporter, Accelerating U.S. Leadership and Advancing Regulatory Modernization1.7.2026 15:00:00 CEST | Press release
Deal establishes Regnology as a central partner in U.S. regulatory modernization, extending reach to over 4,000 financial institutions Regnology, a leading provider at the intersection of regulatory, risk, and supervisory technology, today announced it has entered into a definitive agreement to acquire Fed Reporter, the market-leading U.S. provider of regulatory reporting solutions for financial institutions of all sizes, including banks, credit unions, and bank holding companies. The acquisition marks a pivotal milestone in Regnology’s U.S. expansion, creating the most comprehensive regulatory reporting coverage across the American financial landscape and extending its reach to more than 4,000 institutions from global banks to community lenders. By combining a proven, cloud-first, agentic-first technology foundation with deeply embedded local expertise, Regnology is uniquely positioned to support more efficient, transparent, and data-driven reporting, while strengthening alignment bet
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