Valbiotis a commercially oriented research and development company dedicated to scientific innovation to prevent and combat metabolic and cardiovascular diseases, makes its final visit of the last patient participating in the phase II/III REVERSE-IT study of the active substance TOTUM•63 This international, multi-centre, randomized, placebo-controlled study in 600 untreated pre-diabetics and type 2 diabetics (early stage) aims to evaluate the effectiveness of TOTUM Confirm -63 in impaired glucose metabolism.First results will be available and communicated before the end of H1 2023 according to 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 was designed to address a major unmet need: to target metabolic disorders in the early stages of type 2 diabetes, particularly prediabetes. Prediabetes currently affects nearly 900 million people worldwide, including 128 million in the United States and the top five European 1 countries, for whom no non-drug healthcare product has solid evidence of efficacy.

Nestlé Health Science has exclusive worldwide 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 ingredient, is nearing completion. The completion of the REVERSE-IT study is an unprecedented achievement for Valbiotis: With 600 patients in more than 50 centers worldwide, REVERSE-IT is one of the largest and most ambitious studies worldwide with non-drug approaches to early dysglycemia, from prediabetes to early type 2 diabetes. We would like to acknowledge the long-term work of all teams involved, without which this challenge could not have been challenging. We also thank the Nestlé Health Science teams for their advice and support throughout our strategic partnership on TOTUM•63. The demanding work of database analysis will now begin in the hope that it will reveal the potential of TOTUM•63 for people

Hans-Jürgen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science, adds : “We designed the REVERSE-IT study together with Valbiotis to generate a large clinical dataset on TOTUM•63 for the benefit of people with early-stage dysglycaemia to create. An increasing number of people worldwide are at risk of type 2 diabetes. We welcome the completion of this very ambitious study and look forward to the first results for the management of this early deterioration in glucose metabolism.”

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

Following the collection and monitoring of data from the last protocol follow-up visits, the clinical database is frozen for statistical analysis. At the end of this process, in accordance with Good Clinical Practice, 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 indicated on September 15, 2022 (September 15, 2022, press release ) published schedule has been announced.

About TOTUM•63
TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.
In a phase I/II clinical trial, TOTUM•63 has already been shown to be safe and effective in healthy patients. Results from a randomized, placebo-controlled, international Phase II study showed that TOTUM•63 reduced fasting and 2-hour blood glucose levels, two risk factors for type 2 diabetes, compared to placebo.
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 (in 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi -Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India and South Korea and domestic phases in Brazil, Argentina, Canada, Thailand, Qatar and the United Arab Emirates are ongoing. Production capacity for TOTUM•63 has been validated to North American and European standards. TOTUM•63 already has marketing authorization in relation to its status in Europe.
In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and global commercialization of TOTUM•63. This unique health and nutrition partnership envisages TOTUM•63 being commercialized globally by Nestlé Health Science, potentially before medical approval is obtained in some territories. They will also fund the final phases of TOTUM•63's development.

About Valbiotis
Valbiotis is a commercially oriented research and development company committed to scientific innovation to prevent and control metabolic and cardiovascular diseases, thereby responding to an unmet medical need.
They have taken an innovative approach that aims to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of key metabolic diseases. In doing so, Valbiotis relies on a multi-target strategy made possible by the use of plant-based terrestrial and marine resources.
Internationally, its products shall 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.
The company was founded in La Rochelle in early 2014 and has numerous partnerships with leading academic centres. The company was founded in La Rochelle in early 2014 and has numerous partnerships with leading academic centres. In France, the company has established three sites – Périgny, La Rochelle (17) and Riom (63) – as well as a subsidiary in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been awarded the BPI label as "Innovative Company". Valbiotis has received extensive financial support for its research programs from the European Union through the European Regional Development Fund (ERDF). Valbiotis is an eligible PEA-SME 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 believes that these projections are based on rational assumptions and the information currently available to Valbiotis. However, these forecasts are subject to change as a result of changes in economic conditions and financial markets and certain risks and uncertainties, including those detailed in the forecast filed with the French Financial Markets Authority (AMF) on May 19, 2022 and amended by a supplement on November 8, 2022 general registration document of Valbiotis. This document is available on the company's website ( www.valbiotis.com ).
This press release and the information contained herein does not constitute an offer to sell or a solicitation to buy or subscribe for Valbiotis shares or securities in any country.

1 AEC Partners data on Valbiotis' key markets, 2019

The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.

Contacts
Corporate Communications / 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

 

Source:businesswire.com

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