VALBIOTIS Selected to Present 3 Studies on TOTUM-63 by the European Association for the Study of Diabetes (EASD)
21 Settembre 2020 - 7:35AM
Business Wire
- EASD, the leading European association in the field of
diabetes, has selected the positive results of the international
Phase II clinical study on TOTUM-63 in prediabetes to be presented
next September in its 56th annual meeting. These results were
selected by the American Diabetes Association last June 2020.
- Additionally, two preclinical studies have also been selected,
providing a better understanding of the multitargeted mode of
action of TOTUM-63 and its efficacy in prevention and reversion of
weight gain and its impact in the carbohydrate metabolism.
- The value of VALBIOTIS' scientific and clinical work keeps
gaining momentum, with increased recognition from the international
scientific community.
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.
Pascal SIRVENT, member of the Management Board, Director of
Discovery, Preclinical and Translational Research, states:
"Since 2014, we have been conducting extensive preclinical work on
TOTUM-63 in partnership with French and international universities,
such as Leiden (the Netherlands) or Vanderbilt (USA) universities.
These additional studies are essential, as they guide the clinical
development of the active substances and document their mode of
action. The two studies selected have demonstrated promising
additional effects on the prevention and reversal of weight gain
and its consequences on carbohydrate metabolism. We are now very
proud to present them to the European diabetology community."
The three VALBIOTIS presentations at the EASD 2020 meeting are
available at www.valbiotis.com/scientific-publications.
ABOUT TOTUM-63 TOTUM-63 is a unique and patented
combination of 5 plant extracts that targets the physiopathological
mechanisms of type 2 diabetes. TOTUM-63 has already been shown to
be safe and effective in healthy volunteers in a Phase I/II
clinical study. Results of an international randomized,
placebo-controlled Phase II study showed that TOTUM-63 reduced
fasting and 2-hour blood glucose levels, two risk factors for type
2 diabetes, compared to placebo. In these subjects, who also had
abdominal obesity, TOTUM-63 also significantly reduced body weight
and waist circumference. TOTUM-63 benefits from intellectual
property that has been validated by the granting of patents in the
main world markets: Europe (covering 39 countries), the United
States and Russia, and national phases are underway in more than 20
countries including China, Japan, Brazil and Australia. TOTUM-63's
industrial production capacity, in accordance with North American
and European standards, has been validated. TOTUM-63 already has
marketing authorizations linked to its status in Europe. In
February 2020, VALBIOTIS signed a long-term global strategic
partnership with Nestlé Health Science for the development and
worldwide marketing of TOTUM-63. This unique partnership in the
field of Health Nutrition provides for the worldwide marketing of
TOTUM-63 by Nestlé Health Science, possibly before obtaining a
health claim depending on the region. It will also finance the
final stages of development of TOTUM-63.
ABOUT VALBIOTIS VALBIOTIS is a Research & Development
company committed to scientific innovation for preventing and
combating metabolic diseases in response to unmet medical needs.
VALBIOTIS has adopted an innovative approach, aiming to
revolutionize healthcare by developing a new class of nutritional
health solutions designed to reduce the risk of major metabolic
diseases, based on a multi-target approach and made possible by the
use of plant-based ingredients. Its products are intended to be
licensed to players in the health world. VALBIOTIS was founded in
La Rochelle in early 2014 and has formed numerous partnerships with
top academic centers. The Company has established three sites in
France – Périgny, La Rochelle (17) and Riom (63). VALBIOTIS is a
member of the “BPI Excellence” network and received “Innovative
Company“ status awarded 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
via the European Regional Development Fund (ERDF). VALBIOTIS is a
PEA-SME eligible company. Find out more about VALBIOTIS:
www.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 may be affected by
changes in economic conditions and financial markets, as well as a
certain number of risks and uncertainties, including those
described in the VALBIOTIS registration document, filed with the
French Financial Markets Regulator (AMF) on 31 July 2020
(application number R 120--018). This document is available on the
Company’s website (www.valbiotis.com).
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.
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VALBIOTIS / CORPORATE COMMUNICATION Carole ROCHER / Marc
DELAUNAY +33 5 46 28 62 58 media@valbiotis.com
ACTIFIN / FINANCIAL COMMUNICATION Stéphane RUIZ +33 1 56 88 11
14 sruiz@actifin.fr
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