VALEDIA® – Prediabetes 

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

500

million people worldwide, at least, were prediabetic in 2017, meaning they are at risk of developing type 2 diabetes.

Source: IDF, 2017

Global epidemic

690

million people worldwide will have contracted type 2 diabetes by 2045, according to current forecasts (425 million people counted in 2017).

Source: IDF 2017

The first product clinically proven in people with prediabetes

VALEDIA® is the first product designed to reduce the risk factors for type 2 diabetes, clinically proven in people with prediabetes.

VALEDIA®  aims at obtaining the first health claim related to the risk reduction of Type 2 Diabetes in Europe and North America.

An innovative multi-target action

VALEDIA®  contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts that act synergistically to target the physiopathological mechanisms of type 2 diabetes.

Clinical results

The efficacy of VALEDIA® was evaluated in an international Phase IIA clinical study, led in a prediabetic population. The positive results (topline data) showed that VALEDIA® significantly reduced  fasting glycemia, 2 hours glycemia (OGTT, Oral Glucose Tolerance Test), two risk factors for type 2 diabetes, as well as body weight and waist circumference, 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

VALEDIA®‘s safety and perfect tolerance were validated by a Phase I/II clinical study in healthy volunteers, then confirmed by the Phase IIA clinical study in people with prediabetes.

The results of the Phase I/II clinical study were selected by the American Diabetes Association Scientific Sessions in June 2017.

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.

Last stage of the clinical development

VALEDIA® is entering Phase IIB 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.
The two last Phase IIB studies must confirm the efficacy of VALEDIA® to reduce fasting glycemia versus placebo, the main risk factor for type 2 diabetes, in people with prediabetes. Their launch will occur simultaneously.

Intellectual property

VALEDIA® is protected by patents covering its active ingredient, TOTUM-63.
The protection strategy is global: patent applications have been filed for TOTUM-63 in 61 countries, including Canadian as well as European territories.
The patent was granted in France in 2014, in the United States in 2018, and in Europe in 2019, with a very high level of protection. In addition to the composition of TOTUM-63, the patent also protects its use for health applications specifically defined by VALBIOTIS, based on the product efficacy data.

*United States Patent and Trademark Office

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 steatosis 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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