Valbiotis, a research and development company committed to scientific innovation for the prevention and control of metabolic and cardiovascular diseases, announced the first visit of the first patient in the study of the modality of clinical action on TOTUM • 63 carried out by the ‘Institute of Nutrition and Functionality. Foods (INAF) at Laval University in Quebec City as part of the partnership with Nestlé Health Science. The study is launched today, after receiving permission from Health Canada and CÉRUL2.
This study, co-designed by Valbiotis in consultation with INAF and Nestlé Health Science experts in the framework of the global strategic partnership, will include 20 volunteers and will have to explore the mechanism of action of TOTUM • 63 in humans. It will provide additional data to support scientific communication and support the marketing of TOTUM • 63. It will be scientifically supervised by André MARETTE and Marie-Claude VOHL, professors at the Faculty of Medicine at Laval University and INAF researchers.
Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs, member of the Board of Directors of Valbiotis, comments: “This exploratory study of the mode of action will identify the mechanisms of action of TOTUM • 63 in subjects overweight or associated obesity This will complement the data on the efficacy of the Pivotal Phase II / III REVERSE-IT Clinical Study, which is currently underway, and we look forward to this last straight line to the prediabetes market. to INAF and our partner Nestlé Health Science for their involvement with us. ”
The study of the clinical mode of action on TOTUM • 63 should explore in humans the main hypotheses of the mode of action established by the results of preclinical work. It will include 20 overweight or obese volunteers associated with metabolic abnormalities. Endowed with a large number of scientific objectives, the protocol will evaluate the effect of an administration of TOTUM • 63 for 8 weeks on numerous mechanistic parameters involved in the pathophysiology of prediabetes and type 2 diabetes, through in-depth physiological examinations: mainly intestinal absorption of nutrients, metabolomics, inflammation, composition of the intestinal microbiota and gastrointestinal hormones (incretins, including GLP-1).
As part of the global strategic partnership on TOTUM • 63, the first patient visit announced today is a milestone in a new global payment from Nestlé Health Science to Valbiotis, to be paid during the first half of 2022.
Sébastien PELTIER, CEO and Chairman of the Board of Directors, adds: “2022 will be a decisive year for the acceleration of our clinical schedule with significant results expected in our main indications. In prediabetes, we are now taking a new step that embodies the strength of the project built with our partner Nestlé Health Science. Together, we are moving forward with the implementation of the roadmap that will lead us tomorrow to the launch of a product whose proven scientific value will support its worldwide marketing potential. This milestone is also an opportunity to benefit from a new payment for a milestone that further strengthens our financial position in pursuit of our ambitious strategic roadmap. »
1 Institute of Nutrition and Functional Foods (INAF)
2 Sectoral Committee on Health Sciences of the Humanities Research Committees of Laval University
Source and visual: Valbiotis