Business Wire

Valbiotis Announces the Last Visit of the Last Patient in the Phase II/III REVERSE-IT Study on TOTUM•63, in Partnership with Nestlé Health Science

Share

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible) (Paris:ALVAL), a commercially oriented Research and Development company, committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the last visit of the last patient enrolled in the Phase II/III REVERSE-IT study on the active substance TOTUM•63. This international, multi-center, randomized, placebo-controlled study on 600 untreated prediabetic and type 2 diabetic patients (early stage) is designed to confirm the efficacy of TOTUM•63 on impaired glucose metabolism. The first results will be available and communicated before the end of the first half of 2023, in accordance with the schedule announced on September 15, 2022.

TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. It has been developed to address a large unmet need: to act on metabolic impairments in the early stages of type 2 diabetes, in particular prediabetes. Prediabetes currently affects nearly 900 million people worldwide, including 128 million in the United States and the five main European1 countries, for whom no non-drug health product yet has solid proof of efficacy.

Nestlé Health Science has the exclusive and global commercial rights to use TOTUM•63 in the prediabetes and type 2 diabetes market.

Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs, member of the Valbiotis Executive Committee, comments: "The development of TOTUM•63, our first innovative active substance, is nearing completion. The conclusion of the REVERSE-IT study is an unprecedented achievement for Valbiotis: with 600 patients enrolled in more than 50 centers worldwide, REVERSE-IT is one of the largest and most ambitious studies conducted globally with non-drug approaches in early dysglycemia, from prediabetes to early type 2 diabetes. We would like to pay tribute to the long-term work carried out by all the teams involved, without whom this challenge could not have been met. We also thank the Nestlé Health Science teams for their guidance and support as part of our strategic partnership on TOTUM•63. The demanding work of analyzing the database will now begin, with the hope that it will confirm the potential of TOTUM•63 for people affected by the risk of diabetes and its early stages and pave the way for the commercialization of this breakthrough active substance."

Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science, adds: "We co-designed the REVERSE-IT study with Valbiotis to provide a large clinical dataset on TOTUM•63 for the benefit of people with early dysglycemia. An increasing number of people around the world are at risk of type 2 diabetes. We welcome the completion of this highly ambitious study and look forward to the initial results for the management of this early deterioration in glucose metabolism."

The Phase II/III REVERSE-IT randomized, double-blind, placebo-controlled study includes 600 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage). Its primary objective will be to confirm the reduction of fasting blood glucose levels by TOTUM•63 taken three times daily for a total daily dose of 5 g over 24 weeks. The protocol will also evaluate the effect of the same daily dose of TOTUM•63 on fasting blood glucose levels but taken twice daily. Finally, REVERSE-IT will evaluate the effects of TOTUM•63 on other metabolic parameters of interest.

Following the collection and monitoring of data from the last follow-up medical visits planned in the protocol, the clinical database will be frozen for statistical analysis. At the end of this process in accordance with Good Clinical Practices, Valbiotis confirms that the first results of the REVERSE-IT study will be available and communicated before the end of the first half of 2023, as announced in the schedule published on September 15, 2022 (September 15, 2022, press release).

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 patients 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, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chili, India, South Korea and national phases are still underway in Brazil, Argentina, Canada, Thailand, Qatar, United Arab Emirates. 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 commercially oriented 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.
Internationally, its products are intended to be the subject of licensing and/or distribution agreements with global or regional health and nutrition players. In France, Valbiotis will be responsible for marketing its own products.
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 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 filed to the French Financial Markets Regulator (AMF) on May 19, 2022 and completed by an amendment on November 8, 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.

1AEC Partners data on Valbiotis' key markets, 2019

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
Carole ROCHER
Communication and Public Affairs Director
+ 33 6 77 82 56 88

Marc DELAUNAY
Communication Manager
media@valbiotis.com

Financial communication / Seitosei Actifin
Stéphane RUIZ
Associate Director
+33 1 56 88 11 14
sruiz@actifin.fr

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

PAN Finance Names Libertex ‘Global CFD Broker of the Year’29.3.2024 06:25:00 CET | Press release

As the first quarter of 2024 draws to a close, Libertex is thrilled to announce its first accolade of the new year! The established global financial publication PAN Finance has determined Libertex to be the ‘CFD Broker of the Year – Global 2024’ following a rigorous evaluation process conducted by the publication's highly experienced editorial and research teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328235325/en/ (Graphic: Libertex) PAN Finance is a trusted source of global financial intelligence with an impressively wide readership across 150 countries. Its ecosystem includes a quarterly magazine, special reports, a news website, and various social media channels. As an organisation, PAN Finance is committed to providing concise, intelligent, and up-to-date news for a worldwide readership of specialists spanning the entire finance industry. The company's awards programme aims to serve as a true indicator of exc

Midea Group releases its first-ever ESG brand story with an unexpected VIP visit highlighting its commitment to sustainability.29.3.2024 02:39:00 CET | Press release

Midea Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328526418/en/ Background: Midea Group, a leading global technology group, recently released its 2023 Environmental, Social, and Governance (ESG) Report with ambitious sustainable development goals set for 2030. They include achieving over 500 megawatts of photovoltaic power generation, reducing greenhouse gas emission intensity (scopes 1 and 2) by 0.040, secure Energy Management System Certification for 50 factories, and achieve 100% carbon footprint accounting for major categories of smart home appliances. This is aligned with the Sustainable Development Report Standards of the Global Report Standards of the Global Reporting Initiative (GRI). The new report and campaign focuses on four dimensions: Protect the Blue Planet, Build a Harmonious Community, Practice 'Bring Great Innovations to Life', and Jointly Create the Prosperous Ecology. The campaign: Midea’s ESG

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 16:00:00 CET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 16:00:00 CET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

HiddenA line styled icon from Orion Icon Library.Eye