Tuesday 19 November 2019

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

  • TOTUM-63 reduces inflammation in visceral adipose tissue, one of the
    mechanisms leading to type 2 diabetes and metabolic diseases.
  • The efficacy of TOTUM-63 on sugar and lipid metabolism is confirmed in
    a murine model of prediabetes.
  • These results were obtained by an independent study led by Dr. Bruno
    GUIGAS at Leiden University (Netherlands).

LA ROCHELLE, France–(BUSINESS WIRE)–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 31st,”
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.

ABOUT VALBIOTIS

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:
http://valbiotis.com/

Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL

Disclaimer

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.

Contacts

VALBIOTIS
CORPORATE COMMUNICATION
Carole Rocher /
Marc
Delaunay
+33 5 46 28 62 58
medias@valbiotis.com

FINANCIAL COMMUNICATION
ACTIFIN
Stéphane Ruiz
+33 1 56 88
11 14
sruiz@actifin.fr

MEDIA RELATIONS
MADIS PHILEO
Guillaume De Chamisso
+33 6
85 91 32 56
guillaume.dechamisso@madisphileo.com

UNITED STATES
SOLEBURY TROUT
Rebecca John / Patrick Till
+1
646 378 2935
rjohn@troutgroup.com
ptill@troutgroup.com

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