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 designed to reduce the risk of type 2 diabetes

VALEDIA® is an innovation of worldwide importance designed for prediabetic patients.

Its purpose: to help these at-risk patients delay or even prevent the onset of type 2 diabetes.
It is the first in a new class of latest-generation, plant-based healthcare products developed by VALBIOTIS for the treatment of complex metabolic diseases.

 

An innovative multi-targeted action on the physiology of prediabetes

TOTUM-63, the main active ingredient of VALEDIA®, is composed of a specific and patented combination of 5 plant extracts selected for their effects on metabolism. VALEDIA® acts on several targets of the pathophysiology of type 2 diabetes to reduce the disease clinical risk factors.

This “first-in-class” product is designed to change prediabetes management and to help maintaining the health of prediabetic subjects.

Preclinical data

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 therefore proven to have major and significant effects on the main parameters of glucose metabolism:

  • Decrease in fasting glycemia;
  • Decrease in glycated hemoglobin (HbA1c);
  • Improvement in insulin sensitivity;
  • Improvement in carbohydrate tolerance;
  • 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.

Clinical results

The results of the Phase I/II clinical study led in 2017 were obtained on a population of healthy volunteers.  These studies validated the safety and tolerance of VALEDIA® and provided proof of concept in terms of clinical efficacy, in line with the preclinical results:

  • Improvement in carbohydrate tolerance: 13% decrease in post-prandial glycemic peak;
  • Increase in insulin sensitivity: 41% improvement of the insulin sensitivity index;
  • Spared insulin secretion: 37% decrease in postprandial insulin secretion.

These results were selected by the American Diabetes Association (ADA) in June 2017 for the scientific sessions of its annual Congress.

A multi-targeted mode of action

As with all VALBIOTIS products, TOTUM-63 has a pleiotropic mode of action. The biomolecules comprising TOTUM-63 act in synergy on several major targets involved in the physiopathology of type 2 diabetes:

  • Pancreas: preservation of ß-pancreatic function, maintained insulin secretion capacity;
  • Skeletal muscle and adipose tissue: reduction of peripheral insulin resistance through the restoration of insulin intracellular signaling pathways (Akt);
  • Intestinal microbiota: improvement of the imbalances observed in prediabetes;
  • Liver: decrease in hepatic steatosis, one cause of hepatic insulin resistance.

These combined central and peripheral effects potentialize the impact of TOTUM-63 on carbohydrate metabolism and support the benefits measured in clinical studies.

Ongoing clinical development

VALEDIA® is currently in Phase II of clinical development. This development stage precedes the submission of an application for a health claim recognized by American, European and Canadian regulatory health authorities.
The four Phase II studies which are currently underway or pending must demonstrate the efficacy of VALEDIA® to reduce one or several risk factors of type 2 diabetes in the target population. These studies will include a total of almost 400 prediabetic patients.

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, then in the United States in 2018, with a very high level of protection. The American patent was granted by the USPTO* within an extremely short timeframe. 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