Therapy Areas: Cardiovascular
Valbiotis Announces the First Visit of the First Patient in the TOTUM•63 Mode of Action Clinical Study Conducted by the INAF1, in Partnership with Nestlé Health Science
28 April 2022 - - French research and development company Valbiotis a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the first visit of the first patient in the TOTUM•63 mode of action clinical study conducted by the Laval University Institute of Nutrition and Functional Foods in Quebec City, in partnership with Nestlé Health Science.

The study has now been launched, after receiving approval from Health Canada and the CERUL2.

This study, co-designed by Valbiotis in consultation with experts from the INAF and Nestlé Health Science as part of the global strategic partnership, will include 20 volunteers and will explore the mechanism of action of TOTUM•63 in humans.

It will provide additional data to support scientific communication on TOTUM•63 and accompany its commercialization.

It will be scientifically supervised by André MARETTE and Marie-Claude VOHL, professors at the Laval University Faculty of Medicine and researchers at the INAF.

The TOTUM•63 clinical mode of action study will explore the main hypotheses of the mode of action in humans established thanks to the results of preclinical work. It will include 20 volunteers who are overweight or obese with metabolic abnormalities.

With a large number of scientific objectives, the protocol will evaluate the effect of TOTUM•63 administration for eight weeks on several of the mechanistic parameters involved in the pathophysiology of prediabetes and type 2 diabetes, using in-depth physiological explorations: mainly intestinal nutrient absorption, metabolomics, inflammation, gut microbiota composition and gastrointestinal hormones (incretins, including GLP-1).

As part of the global strategic partnership on TOTUM•63, TODAY's announcement of the first visit of the first patient is a milestone that results in a new lump-sum payment from Nestlé Health Science to Valbiotis, to be received in the first half of 2022.

Created in the early 2000s to address the challenges of sustainable nutrition and the prevention of metabolic diseases, the INAF brings together some 100 researchers in the biofood, health and social sciences sectors from 14 universities and scientific institutions in Quebec.

Its multidisciplinary approach and the quality of the projects it coordinates have earned it a reputation for scientific excellence on the North American continent.

TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.

TOTUM•63 has already been shown to be safe and effective in healthy volunteers in a Phase I/II clinical study.

Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM•63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes.

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 (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand and national phases are still underway in a dozen other countries including Brazil and Australia.

Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe.

In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63.

This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a worldwide scale, possibly before obtaining a medical clearance depending on the area.

They will also fund the final stages of development of TOTUM•63.

Valbiotis is a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.

Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.

Its products are intended to be licensed to players in the health sector.

Created at the beginning of 2014 in La Rochelle, the company has forged numerous partnerships with leading academic centers. The company has established three sites in France Périgny, La Rochelle and Riom and a subsidiary in Quebec City (Canada).

Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative company" by the BPI label.

Valbiotis has also been awarded "Young Innovative company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund. Valbiotis is a PEA-SME eligible company.
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