Metformin + TOTUM-63 Combination: VALBIOTIS Announces First Preclinical Data for Possible Use in Diabetes Real Life Practice

∙ No risk of hypoglycemia for the metformin + TOTUM-63 combination shown in preclinical studies

∙ First positive preclinical results on insulinemia, during an oral glucose tolerance test

Regulatory News:

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(Graphic: VALBIOTIS)

VALBIOTIS (Paris:AVAL) (FR0013254851 – ALVAL / PEA/PME eligible [the PEA-PME scheme is a share savings plan aimed at providing financing aid to SMEs]), a company specialized in the development of innovative nutrition solutions designed to prevent cardiometabolic diseases and provide nutritional support for patients, today announces initial positive preclinical data on the combination of metformin with TOTUM-63, for possible use in diabetes real life practice. These results were selected and will be presented during the annual congress of the International Diabetes Federation in Abu Dhabi (UAE) on December 5, 2017.

Metformin is considered as the first-line standard treatment prescribed for newly diagnosed type 2 diabetic patients. This medication belongs to the class of oral antidiabetic drugs and is used to normalize fasting glycemia by increasing insulin sensitivity and by reducing neoglucogenesis (production of glucose by the liver).

> Metformin as a possible combination: an additional asset for the use of VALEDIA® in real life practice

While the safety of TOTUM-63 alone has already been proven, VALBIOTIS provides new data for the active ingredient of VALEDIA® in order to supply all the necessary data for patients and healthcare professionals to use this product in real life. Tested in combination with metformin in murine models (C57BL6/J), TOTUM-63 has not demonstrated any risk of hypoglycemia.

Furthermore, initial data in these murine models suggest a beneficial potentiating effect of TOTUM-63 on the reduction of insulinemia induced by metformin, in response to an oral glucose tolerance test (Fig. 1).

Figure 1: Insulinemic response in murine models during an oral glucose tolerance test (OGTT) after 16 weeks of complementation with metformin, alone or in combination with TOTUM-63 (*p <0.05).

OGTT: Oral glucose tolerance testAUC: Area under curveHFD: High-fat diet

These favorable initial results pave the way for a clinical trial in type 2 diabetic patients treated with metformin, which will provide all the necessary data for an optimal use of VALEDIA® in current diabetes practice.

ABOUT VALBIOTIS

VALBIOTIS specializes in developing innovative nutrition solutions designed to prevent cardiometabolic diseases and provide nutritional support for patients. Its products are made for manufacturers in the agri-food and pharmaceutical industries. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.

VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers in France and abroad, including the La Rochelle University, the CNRS and the Clermont Auvergne University located in Clermont-Ferrand, where the company opened a second office. These agreements enable it to benefit from a considerable leverage effect since it was set up thanks, in particular, to the experts and technical partners mobilized for these projects. VALBIOTIS is a member of the “BPI Excellence” network and received the “Innovative Company” status accorded by BPI France. Valbiotis has also been awarded “Young Innovative Company” status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF).

Find out more about VALBIOTIS:http://valbiotis.com/

Name: VALBIOTISISIN code: FR0013254851Mnemonic code: ALVAL

View source version on businesswire.com: http://www.businesswire.com/news/home/20171204005448/en/

FINANCIAL COMMUNICATIONACTIFINStéphane RUIZ, +33 1 56 88 11 14sruiz@actifin.frorPRESS RELATIONSALIZE PRCaroline CARMAGNOL / Wendy RIGAL+33 1 44 54 36 66valbiotis@alizerp.comorCOMMUNICATION DEPARTMENTVALBIOTISMarc DELAUNAY, +33 5 46 28 62 58marc.delaunay@valbiotis.com

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