VALBIOTIS Selected to Present 3 Studies on TOTUM-63 by the European Association for the Study of Diabetes (EASD)

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 - ALVAL, eligible for the PEA/SME), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the selection of 3 studies on TOTUM-63 by the European Association for the Study of Diabetes (EASD), which will be presented at the association's annual meeting in September 2020.

For the third consecutive year, VALBIOTIS has seen its results on TOTUM-63, its active substance designed to reduce the risk of type 2 diabetes, selected by the main European diabetes meeting. This year, VALBIOTIS will present 3 studies at this major event, to be held from 22 to 25 September in virtual format due to the COVID-19 pandemic.

The clinical results of the international Phase II study of TOTUM-63 will first be presented by Prof. Jean-Marie Bard in the form of an e-poster (Abstract #621). Completed in the summer of 2019, this study showed a significant reduction in the main risk factors for type 2 diabetes (glycemic parameters, waist circumference, body weight) in prediabetic people, compared to a placebo. Already selected by the American Diabetes Association last June, these results have now been accepted by the two main scientific societies in the field of diabetes worldwide.

Murielle CAZAUBIEL, member of the Management Board and Director of Development and Medical Affairs at VALBIOTIS, comments: "The excellent results of the TOTUM-63 Phase II clinical study exceeded our expectations and enabled us to enter into a strategic partnership with Nestlé Health Science last February. In 2020, we have launched a strategy for the scientific communication of these results, which has already led to selection for presentations at the two largest diabetes meetings in the world, the ADA and EASD, within three months. These publications constitute indisputable recognition of the quality of our work. They are also a great source of pride and an additional incentive to complete the clinical development of TOTUM-63 with our partner Nestlé Health Science."

In addition to these clinical results, two preclinical studies demonstrating the positive effects of TOTUM-63 on obesity and carbohydrate metabolism disorders have also been selected by the EASD (Abstract #448 and #623). These studies highlight the efficacy of TOTUM-63 through two protocols: a protocol for the prevention of weight gain and associated metabolic disorders, carried out by the VALBIOTIS teams, and a protocol for the management of obesity and acquired disorders, carried out by the team of Dr Bruno Guigas (University of Leiden, Netherlands) with Vanderbilt University (Nashville, USA), one of the American expert centers for the study of diabetes. This preclinical work shows a reduction in body weight thanks to TOTUM-63 as well as an improvement in carbohydrate parameters in both protocols. It also provides a better understanding of the multi-targeted mode of action of TOTUM-63: reduced intestinal absorption of lipids and glucose, increased sensitivity of peripheral tissues to insulin and increased energy expenditure.