Prediabetes is defined by learned societies as a risk condition for developing type 2 diabetes. It corresponds to a moderate rise in fasting glycemia and/or a glucose intolerance and/or a moderate increase in glycated hemoglobin levels (HbA1c).
Without effective treatment, 70% to 90% of prediabetic patients will develop type 2 diabetes during their lifetime.
Although type 2 diabetes is an irreversible condition in the large majority of cases, prediabetes itself can be reversed. It should be seen as a warning sign and an opportunity to take action.
The only treatment option available is adopting a healthier diet and lifestyle, as there is currently no drug or healthcare product that is specifically indicated for prediabetic patients.
Source : Tabak et al, The Lancet, 2012Learn more
million people worldwide, at least, were prediabetic today, meaning they are at risk of developing type 2 diabetes.
Source: AEC Partners 2020
million people worldwide will have contracted type 2 diabetes by 2045, according to current forecasts (463 million people counted in 2019).
Source: IDF 2019
TOTUM-63 is the first product designed to reduce the risk factors for type 2 diabetes, clinically proven in people with prediabetes. TOTUM-63 is a unique and patented combination of 5 plant extracts that act synergistically to target 5 key organs of the physiopathology of type 2 diabetes. This active substance aims at obtaining the first health claim related to the risk reduction of Type 2 Diabetes in Europe, North America and other key territories.
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 clinical development stages of TOTUM-63.
The efficacy of TOTUM-63 was evaluated in a Phase II international clinical study, in prediabetics, pour évaluer son efficacité. The positive results showed that TOTUM-63 significantly reduced fasting glycemia and 2 hours glycemia (OGTT, Oral Glucose Tolerance Test), two risk factors for type 2 diabetes. TOTUM-63 also reduced body weight, waist circumference, triglycerides blood level and elevated blood pressure versus placebo:
This study was randomized and double blind placebo-controlled. Full information is available in the Company corporate presentation.
Safety and perfect tolerance were validated by a Phase I/II clinical study in healthy volunteers, then confirmed by the Phase II clinical study in people with prediabetes. The results of the Phase I/II clinical study were selected by the Scientific Sessions of the American Diabetes Association in June 2017.
TOTUM-63 is entering Phase II/III of clinical development, the last stage before the submission of an application for a health claim recognized by American, European and Canadian regulatory health authorities. This process does not need any Phase III study.
This international study, randomized, placebo-controlled, double blind, called “REVERSE-IT”, will be launched mid-2020.
It will include 600 people with prediabetes or early-stage untreated Type 2 Diabetes, with the reduction in fasting glycemia as primary endpoint.
The REVERSE-IT study will pursue two main strategic objectives:
The protection strategy is global: patent applications have been filed for TOTUM-63 in more than 60 countries, including key territories: Europe, USA, Canada, China, Russia, Japan, Brazil, Australia.
The patent was granted in France in 2014, in the United States in 2018, in Europe in 2019 (39 countries) and in Russia in 2020, with a very high level of protection.
TOTUM-63, a unique and patented combination of 5 plant extracts that targets several physiopathological mechanisms of type 2 diabetes. This synergistic mode of action was highlighted in preclinical studies:
The active substance TOTUM-63 is the result of an intensive research and development program lasting several years, combining analytical chemistry and systematic screening on type 2 diabetes and prediabetes in vivo models.
During preclinical studies, TOTUM-63 has proven to have major and significant effects:
These results were selected by the American Diabetes Association (ADA) for the scientific sessions of its annual Congress in June 2016.