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Valbiotis
Will Present Significant Preclinical Results for Its Active Substance TOTUM•448 Against
Fatty Liver Diseases (NAFL and NASH)
, at the Annual Meeting of the American Association for the Study of
Liver Diseases
(AASLD)
2022-10-27
·
BioSpace
TOTUM•448 is an innovative plant-based patented active substance developed by
Valbiotis
, a young French SME, to counteract the development of
metabolic liver diseases
(NAFL and NASH1). In two preclinical models that mimic the development of fatty liver disease in humans, two studies demonstrate the broad efficacy of TOTUM•448 on the key mechanisms of these diseases, from the earliest stages: Reduction of fat accumulation in the liver, e.g.
hepatic steatosis
. Reduction of
hepatic inflammation
, which causes damage to the liver. Improvement of certain markers of
fibrosis
. These very promising results have been selected for presentation at the annual meeting of the AASLD, the leading American learned society for
liver diseases
, in Washington (USA), November 4-8, 2022.
Metabolic liver diseases
(NAFL,
NASH
), linked to overweight, are spreading throughout the world and can lead to severe
liver damage
requiring transplantation; its early management is all the more essential as no treatment is yet available. The studies were carried out by
Valbiotis
research teams at its Riom center (Puy-de-Dôme), in collaboration with the Hospices
Civils de Lyon
, and by the
University of Leiden
(Netherlands). LA ROCHELLE, France--(BUSINESS WIRE)-- Regulatory News:
Valbiotis
(FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating
metabolic and cardiovascular diseases
, will present the significant preclinical results of TOTUM•448, a non-drug, plant-based active substance, against
metabolic liver diseases
(NAFL and
NASH
), at the annual meeting of the American Association for the Study of
Liver Diseases
, from November 4 to 8, 2022. These results demonstrate the efficacy of TOTUM•448 in the early stages of these diseases, on
steatosis
,
inflammation
and
fibrosis
of the liver. The two studies presented were conducted by
Valbiotis
teams at its R&D center in Riom (Puy-de-Dôme) in collaboration with the Hospices Civils
de Lyon
and by teams from the
University of Leiden
(Netherlands). Pascal SIRVENT, Chief Scientific Officer, member of the
Valbiotis
Board of Directors, states: "The excellent results that will be presented acknowledge extensive work in designing, refining and testing TOTUM•448, an innovative plant-based active substance. TOTUM•448 is the result of our combined expertise in plant-based substances and in
metabolic diseases
, and was specifically designed for
metabolic liver diseases
, or
fatty liver diseases
such as
NASH
. The selection of these results by the AASLD annual meeting, the world reference in the field, is a recognition of the real potential of TOTUM•448 in
metabolic liver diseases
, which are growing rapidly worldwide and for which no specific treatment exists today. We would like to thank our academic partners on this project, the
University of Leiden
and the Hospices Civils
de Lyon
." TOTUM•448 results: broad efficacy on key parameters of
fatty liver diseases
, from the earliest stages Two studies will be presented at the AASLD world congress in two preclinical models of
fatty liver diseases
, which mimic the development of the disease in humans. They showed the efficacy of TOTUM•448 on
hepatic steatosis
and
inflammation
and suggested an improvement in certain markers of
fibrosis
, the first three stages of the development of these diseases. First study: preventive efficacy of TOTUM•448 against fatty liver disease This first protocol evaluated the efficacy of this active substance in preventing the development of
fatty liver diseases
in a model of induced
obesity
in golden hamsters. The animals were separated into four groups: a control group and three groups fed a high-fat diet, two of which were simultaneously supplemented with TOTUM•448 at two different doses. At the end of the study (12 weeks), TOTUM•448 significantly reduced
hepatic steatosis
with a dose-dependent effect. This accumulation of triglycerides and cholesterol in the liver, a consequence of an excessively rich diet, is the first step in the development of
metabolic liver diseases
. Concurrent limitation of blood triglyceride and cholesterol levels was recorded, suggesting a major preventive effect of TOTUM•448 on the regulation of lipid metabolism. Second study: the "curative" efficacy of TOTUM•448 on already established
fatty liver diseases
This second "reversal" protocol evaluated the efficacy of TOTUM•448 in a model of previously developed liver pathology. The animals were separated into five groups: a control group and four groups fed a high-fat diet only, for 12 weeks. Of these four groups that had developed
liver disease
, three were then supplemented with TOTUM•448 for four weeks at three different doses while continuing their high-fat diet. By the end of the study, TOTUM•448 had reduced the level of fat in the liver (
steatosis
), but also reduced immune markers of
liver inflammation
and the ballooning score (swelling of the liver cells). At the same time, TOTUM•448 produced marked positive effects on metabolic parameters strongly involved in the early stages of the disease (insulin sensitivity, glucose tolerance). In both studies, TOTUM•448 reduced the expression of genes involved in
inflammation
and
liver fibrosis
, two key steps in the progression of
fatty liver diseases
. Vivien CHAVANELLE, PhD, Research officer and project manager of the TOTUM•448 program for
Valbiotis
, comments: "We have developed TOTUM•448 for the management of
fatty liver diseases
in their early stages. The excellent results of these studies converge to demonstrate a strong efficacy of TOTUM•448 on these very early key mechanisms of
fatty liver diseases
: the initial accumulation of fat in the liver and
inflammation
. Our data even suggest an effect on
fibrosis
, which is observed at slightly later stages. This is a real success and opens the way to an effective and totally new, non-drug preventive approach. We are very proud to present these promising data to the scientific community and hepatology specialists gathered in Washington for the AASLD congress". NAFL and
NASH
: an alarming global picture
Metabolic liver diseases
or NAFLD (
non-alcoholic fatty liver diseases
) constitute a spectrum of diseases that extends from simple isolated non-
alcoholic fatty liver (NAFL)
to
non-alcoholic steatohepatitis (NASH)
. These
liver diseases
are closely related to other
metabolic disorders
(
obesity
,
insulin resistance
,
dyslipidemia
,
type 2 diabetes
,
hypertension
). Their global prevalence, including all stages, is estimated at 25% worldwide2. NAFL, the first stage of these diseases, is characterized by the accumulation of fat in the liver and is estimated to affect 18.5 to 23.5% adults in the world3. It progresses to
NASH
when inflammatory processes and then
fibrosis
damage the liver tissue. At this advanced stage, the risk of
liver failure
,
cirrhosis
and
hepatocellular carcinoma
increases. In the United States,
NASH
is now the second most common reason for liver transplantation4. No proven therapeutic or preventive solution is yet available for these
liver diseases
. Posters presentation Poster: #2559 Title: TOTUM•448 improves
diet-induced non-alcoholic steatohepatitis
in golden Syrian hamsters fed a western-diet. Authors: Chavanelle V. et al. Poster: #2483 Title: The novel plant-based active principle TOTUM•448 decreases
hepatic steatosis
and
inflammation
in diet-induced NAFLD mice. Authors: Lambooij JM. et al. About
Valbiotis
Valbiotis
is a
Research & Development company
committed to scientific innovation for preventing and combating
metabolic and cardiovascular diseases
in response to unmet medical needs.
Valbiotis
has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic and cardiovascular dis-eases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine re-sources. Its products are intended to be licensed to players in the health sector. Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec City (Canada).
Valbiotis
is a member of the “BPI Excellence” network and has been recognized as an “Innovative Company” by the BPI label.
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. For more information about
Valbiotis
, please visit: Name:
Valbiotis
ISIN code: FR0013254851 Ticker symbol: ALVAL EnterNext© PEA-PME 150 This press release contains forward-looking statements about
Valbiotis
’ objectives.
Valbiotis
considers that these projections are based on rational hypotheses and the information available to
Valbiotis
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 certain risks and uncertainties, including those described in the
Valbiotis
Universal Registration Document filed to the French Financial Markets Regulator (AMF) on May 19, 2022. This document is available on the Company’s website ( ). This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to
Valbiotis
’ shares or financial securities in any country. 1 NAFL: non-alcoholic fatty liver;
NASH
:
non-alcoholic steatohepatitis
. 2 Younossi ZM et al. Global epidemiology of
nonalcoholic fatty liver disease
, Hepatology, 2016. 3 Internal estimation, based on Younossi ZM et al. Global epidemiology of
nonalcoholic fatty liver disease
, Hepatology, 2016. 4 Cholankeril G, et al. Liver Transplantation for
Nonalcoholic Steatohepatitis
in the US: Temporal Trends and Outcomes. Dig Dis Sci. 2017.
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机构
European Regional Development Fund Erdf
Innovative Technology
Valbiotis SA
[+3]
适应症
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脂肪肝
炎症
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