TOTUM-63

Prediabetes: an unmet global need

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, 2012

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Key figures

A population at risk

900

million people worldwide, at least, were prediabetic today, meaning they are at risk of developing type 2 diabetes.

Source: AEC Partners 2020

Global epidemic

700

million people worldwide will have contracted type 2 diabetes by 2045, according to current forecasts (463 million people counted in 2019).

Source: IDF 2019

The first product clinically proven in people with prediabetes

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.

A strategic partnership with Nestlé Health Science

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.

Clinical results

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:

  • Fasting glycemia reduced by 9.3%;
  • 2 hours glycemia (OGTT) reduced by 22.5%;
  • Body weight decreased by 1.9 kg;
  • Waist circumference decreased by 4.48 cm;
  • Safety and tolerance confirmed.

This study was randomized and double blind placebo-controlled. Full information is available in the Company corporate presentation.

Safety and tolerance

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.

Last stage of the clinical development

TOTUM-63 is entering Phase II/III of clinical development, with the reduction of fasting glycemia as primary endpoint. This stage precedes 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.

Intellectual property

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.

A multi-target mode of action

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: 

  • Skeletal muscle and adipose tissue: reduction of insulin resistance, restoration of insulin intracellular signaling pathways (Akt), reduction of inflammation in adipose tissue;
  • Pancreas: preservation of insulin secretion capacity;
  • Liver: decrease in hepatic steatosis, one cause of hepatic insulin resistance;
  • Intestinal microbiota: improvement of overall composition and imbalances observed in prediabetes.

Preclinical data on metabolism

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:

  • Improvement in the main parameters of carbohydrate metabolism;
  • Improvement in  body weight and body composition;
  • Reduction of hepatic and blood triglycerides levels.

These results were selected by the American Diabetes Association (ADA) for the scientific sessions of its annual Congress in June 2016.

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