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VALBIOTIS to Present Novel Data about TOTUM-63 and Metabolic Diseases Prevention at the 2019 Scientific Sessions of the American Diabetes Association

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for the treatment and prevention of metabolic diseases, today announced that new preclinical results of TOTUM-63 obtained independently by Leiden University (Netherlands) will be presented at the 2019 scientific sessions of the American Diabetes Association, being held from June 7 to 11 in San Francisco, California. In a murine model of prediabetes, TOTUM-63 reduced inflammation in visceral adipose tissue, one of the pathophysiological mechanisms of metabolic diseases, especially type 2 diabetes. Moreover, this study also confirmed the efficacy of TOTUM-63 on sugar and lipid metabolism in this preclinical model.

"This study from Leiden University is important from a scientific standpoint: it demonstrates a new effect of TOTUM-63, the active substance of lead product candidate VALEDIA ® , on visceral adipose tissue inflammation that enriches the multi-target mode of action of TOTUM-63. On the clinical side, as previously announced, we expect to report the results of the international Phase IIA clinical study of VALEDIA ® before July 31 st ," comments Sébastien PELTIER, CEO of VALBIOTIS.

Anti-inflammatory action on visceral adipose tissue

"Obesity, in both humans and mice, leads to an increase and an activation of macrophages in visceral adipose tissue. These immune cells are involved in maintaining a silent metabolic inflammation, thus reducing the body's ability to use insulin. By reducing this inflammation and increasing insulin sensitivity in adipose tissue, TOTUM-63, the active substance of VALEDIA ® , would contribute to the reduction of the release of lipids into the bloodstream," specifies Dr. Bruno GUIGAS, researcher at Leiden University (Netherlands), the lead investigator of the study.

The discovery of this new effect further enriches the multi-target mode of action of TOTUM-63, which was presented at the European Association for the Study of Diabetes (EASD) congress in 2018. This mode of action would already combine the preservation of the pancreas, the improvement of insulin signaling in the muscle and the adipose tissue, the reduction in hepatic steatosis and an improved composition of the intestinal microbiota.

About TOTUM-63, the active substance of VALEDIA ®

Prediabetes is a growing public health issue worldwide that has been acknowledged by international organizations. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes.

VALEDIA® intend to be the first natural and clinically proven solution specifically designed for prediabetics. VALEDIA® contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.

The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk of type 2 diabetes.

TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the first international Phase IIA study are expected before 31 July 2019.


VALBIOTIS is a French Research & Development company committed to scientific innovation for the treatment and prevention of metabolic diseases. Its products are made for major players in the health care sector. 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 La Rochelle University, the CNRS and Clermont Auvergne University located in Clermont-Ferrand. These partnerships have enabled Valbiotis to benefit from strong financial leverage, particularly thanks to experts and technical partners who support its projects. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and an American office in Boston (MA).

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). VALBIOTIS is a PEA-SME eligible company.

Find out more about VALBIOTIS:

ISIN code: FR0013254851
Mnemonic code: ALVAL


This press release contains forward-looking statements about VALBIOTIS' objectives, based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 5 April 2017 (application number I.17-012), as well as in the 2017 annual financial report, filed with AMF on 3 April 2018. This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, VALBIOTIS' shares or securities in any country.


VALBIOTIS CORPORATE COMMUNICATION Carole Rocher / Marc Delaunay +33 5 46 28 62 58

FINANCIAL COMMUNICATION ACTIFIN Stéphane Ruiz +33 1 56 88 11 14

MEDIA RELATIONS MADIS PHILEO Guillaume De Chamisso +33 6 85 91 32 56

UNITED STATES SOLEBURY TROUT Rebecca John / Patrick Till +1 646 378 2935



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