- Two in-depth studies on TOTUM•070 conducted jointly by
Valbiotis' preclinical platform and the University of Leiden
(Netherlands), have been selected by the annual meeting of the AHA,
the leading American learned society in the cardiovascular
field.
- Results showing a dose-dependent reduction of 38 to 47% of
"bad" cholesterol*1 (including LDL cholesterol) by TOTUM•070, as
well as a reduction of total cholesterol and blood triglycerides,
in two in vivo models predictive of human physiology.
- First data in favor of a multi-target mode of action of
TOTUM•070, with revealed effects on the gut and liver, involving
lipid metabolism and inflammation.
- Excellent and very promising results for the clinical
development of TOTUM•070 in hypercholesterolemia: the Phase II
HEART clinical study, which has completed enrolment, will deliver
its results in the second quarter of 2022, with LDL cholesterol
reduction as the primary endpoint.
Regulatory News:
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20211114005021/en/
TOTUM•070 preclinical results AHA 2021
(Graphic: Valbiotis)
Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA / SME
eligible), a Research and Development company committed to
scientific innovation for preventing and combating metabolic
diseases, announces the selection of TOTUM•070's positive
preclinical results in hypercholesterolemia by the annual meeting
of the American Heart Association, the leading American learned
society in the cardiovascular field.
Valbiotis is presenting two posters on TOTUM•070 at the AHA
meeting, which is being held November 13-15, 2021, in virtual
format. The results presented show a significant reduction in total
cholesterol and particularly "bad" cholesterol (including LDL
cholesterol)*, as well as initial data in favor of a multi-target
mode of action on lipid metabolism. They support the potential of
TOTUM•070, currently in Phase II of its clinical development
against hypercholesterolemia. Recruitment has been completed and
results are expected in the second quarter of 2022, with LDL
cholesterol reduction as the primary endpoint.
TOTUM•070 is an innovative active substance based on a
combination of 5 plant extracts (without phytosterols or red yeast
rice), designed to reduce LDL cholesterol, a cardiovascular risk
factor and the primary cause of atherosclerosis. It is developed
for people with mild to moderate, untreated
hypercholesterolemia.
The two studies presented at the AHA congress confirm the
efficacy of TOTUM•070 on cholesterol and blood lipids and provide
initial data on the mode of action of this active substance. In the
two in vivo models explored, the work demonstrates that TOTUM•070
largely prevents hypercholesterolemia, with a dose-dependent
reduction in "bad" cholesterol* of up to 47%. The first data on
mode of action also reveal significant effects on several key
mechanisms for the regulation of lipid metabolism, notably
intestinal, hepatic and inflammatory.
This in-depth work is the result of close cooperation between
Valbiotis' preclinical platform in Riom (Puy de Dôme) and Bruno
GUIGAS' team at the University of Leiden (Netherlands), one of the
Company's longstanding academic partners.
Pascal SIRVENT, Director of Discovery, Preclinical and
Translational Research, member of the Valbiotis Board of Directors,
comments: "These results on TOTUM•070 are striking in their
consistency. First, they confirm a strong and dose-dependent
preventive effect on blood cholesterol, the ultimate target of this
active substance. Furthermore, they confirm the hypothesis of a
multi-target mode of action on the regulation of lipid metabolism,
a central objective of our plant-based approach. This is an
important data set for the development and future commercialization
of TOTUM•070 in hypercholesterolemia and a very promising signal
for ongoing clinical studies. Their selection by the American Heart
Association Congress is of course a great source of pride and
recognition of the quality of the work done by our teams and those
of the University of Leiden."
Bruno GUIGAS, Assistant Professor at the University of Leiden
(Netherlands), adds:
"This research project had an exciting overall ambition for
TOTUM•070, for the prevention of hypercholesterolemia. For our
part, we focused on the intestinal mode of action of this active
substance and demonstrated a significant effect on fat absorption.
This is a particularly positive result on this well-known lever of
lipid metabolism regulation. As an R&D partner of Valbiotis
since 2015, we are very pleased with our contribution to the
success of these joint projects, whose benefits and value are
clearly demonstrated through their selection by the AHA
Congress."
TOTUM•070 efficacy and mode of action results presented at AHA
2021
Both studies were conducted in two in vivo models, predictive of
human pathophysiology, where hypercholesterolemia was induced by a
high-fat diet. TOTUM•070 was administered according to a prevention
protocol together with the high-fat diet. The design included two
controls: one with a high-fat diet alone and the other with a
normal diet. The first study was mainly oriented to efficacy
objectives and tested TOTUM•070 at three different doses for 12
weeks. The second study, oriented to mode of action hypotheses,
tested 2 different doses for 6 weeks. In both protocols, the
results show a significant reduction of cholesterol levels by
TOTUM•070 compared to a high-fat diet alone, confirming the
preventive effect sought with this active substance.
The first study demonstrates a profound efficacy of TOTUM•070 on
circulating lipids, with a dose-dependent reduction of 37-48% of
"bad" cholesterol (non-HDL)*, 31-42% of total cholesterol as well
as 30-46% of blood triglycerides, compared to the high-fat diet
alone, after 12 weeks.
In terms of mode of action, the second study provided
exploratory data indicating two major effects of TOTUM•070:
reduction of intestinal absorption of lipids and reduction of their
accumulation in the liver.
In both models, gene expression analyses also showed that
TOTUM•070 administration normalized many markers involved in lipid
metabolism as well as some pro-inflammatory markers, whereas they
were strongly altered by a high-fat diet alone.
Link to the posters: https://www.valbiotis.com/en/publications/
About TOTUM•070
TOTUM•070 is an innovative active substance derived from food
plant extracts, without phytosterols or red yeast rice, developed
to act on lipid metabolism in people with hypercholesterolemia.
TOTUM•070 is currently being tested in a Phase II clinical
trial, the HEART study, an international, multi-center, randomized,
placebo-controlled study on 120 volunteers with mild to moderate
hypercholesterolemia. Enrolment in this study was completed in
September 2021 and results are expected in the second quarter of
2022.
At the end of its development, this new Health Nutrition product
will be positioned in particular in people with LDL
hypercholesterolemia, for levels up to 190 mg/dl, with a moderate
overall cardiovascular risk. TOTUM•070 could be recommended to this
large population for whom no drug therapy is currently recommended
as first-line treatment, with the objective of reducing LDL
cholesterol levels and thus the overall cardiovascular risk.
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 health
nutrition products designed to reduce the risk of major metabolic
diseases, relying on a multi-target strategy enabled by the use of
plant-based terrestrial and marine resources.
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:
www.valbiotis.com
Name: Valbiotis ISIN code: FR0013254851 Ticker symbol: ALVAL
EnterNext© PEA-PME 150
1"Bad" cholesterol is the non-HDL fraction of cholesterol. It
includes ApoB lipoproteins, i.e. VLDL and LDL cholesterol.
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
approved by the French Financial Markets Regulator (AMF) on July
27, 2021 (application number R 21-039). This document is available
on the Company’s website ( www.valbiotis.com).
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211114005021/en/
Corporate communication / Valbiotis Carole Rocher / Marc
Delaunay +33 5 46 28 62 58 media@valbiotis.com
Financial communication / Actifin Stéphane Ruiz +33 1 56 88 11
14 sruiz@actifin.fr
Valbiotis (EU:ALVAL)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Valbiotis (EU:ALVAL)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024