Valbiotis Announces the Positive Results of Its Clinical Study on the Bioavailability and Mode of Action of TOTUM•070, Against Hypercholesterolemia
29 Mars 2022 - 7:35AM
Business Wire
- This innovative study is the first to characterize the
metabolites of TOTUM•070 in humans and their mode of action in the
liver in a population of 10 healthy volunteers. TOTUM•070 was
tested at its clinical daily dose (5g), used also in the Phase II
HEART clinical trial.
- Metabolomic analysis confirms the presence of 22 metabolites of
interest in the serum of volunteers after oral ingestion of 5g of
TOTUM•070.
- Mode of action results demonstrate that TOTUM•070 and its
metabolites exert a dual effect on human liver cells:
- Inhibition of the de novosynthesis pathway of cholesterol1, a
key mechanism in the fight against hypercholesterolemia;
- Inhibition of cholesterol storage in the liver.
- These data confirm this active substance’s potential for
regulating cholesterol metabolism in humans.
- As per the announced schedule, the Phase II HEART clinical
efficacy study results will be communicated in the second quarter
of 2022, the primary endpoint being the reduction of blood
LDL-cholesterol.
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,
announces the positive results of its clinical study on the
bioavailability and mode of action of TOTUM•070 against
hypercholesterolemia.
This innovative protocol, involving 10 healthy volunteers, has
first confirmed the presence of 22 metabolites2 of interest in the
serum3 of volunteers. The analyses were conducted following oral
administration of the clinical dose of 5g of TOTUM•070, used also
in the Phase II HEART study. Most of the 22 metabolites are already
known for their activity on metabolism. Mode of action analyses
then demonstrated, among other things, two effects of TOTUM•070 on
human liver cells: inhibition of the cholesterol synthesis pathway
and inhibition of cholesterol storage in hepatocytes. These two
effects on cholesterol in the liver, which is one of the main
metabolic organs, speak in favor of TOTUM•070’s potential against
hypercholesterolemia. Following on from these positive results,
Valbiotis will announce the outcome of its Phase II HEART clinical
efficacy study in the second quarter of 2022, as planned. Its
primary endpoint is the reduction of blood LDL-cholesterol.
Pascal SIRVENT, Director of Discovery and Preclinical and
Translational Research and Member of the Board of Directors,
states: “For the first time, this clinical study has evaluated the
bioavailability and hepatic mode of action of TOTUM•070 in humans.
The results live up to our expectations: we can confirm that
TOTUM•070 contains many metabolites of interest for regulating
cholesterol. Most importantly, the results show that these
metabolites are bioavailable in humans and have two significant
effects on the regulation of cholesterol in the cells of the human
liver, one of the main metabolic organs. These novel clinical data
build on the positive preclinical results presented in 2021 and
pave the way for further mode-of-action investigations in the
liver. Above all, they confirm the potential of TOTUM•070 against
hypercholesterolemia in humans, pending the imminent results of our
Phase II clinical efficacy study.”
Murielle CAZAUBIEL, Director of Medical, Regulatory and
Industrial Affairs and Member of the Board of Directors, adds:
“During this clinical study on TOTUM•070, we used an innovative
methodology adapted to our plant-based active substances that
combines metabolomics and mode of action, which is now producing
results. This is a positive clinical development and a very
encouraging sign while we wait for the Phase II HEART clinical
efficacy results, which will become available in the second quarter
of 2022.”
Results of the clinical study on bioavailability and mode of
action
This study was conducted on 10 healthy volunteers in an
open-label setting and followed a protocol combining metabolomics
and mode of action, designed and implemented by Clinic’n’Cell.
Professor Gisèle PICKERING, coordinator of the Clinical
Investigation Center of the Clermont-Ferrand University Hospital,
was Principal Investigator4.
Metabolomic analysis consists of characterizing the metabolites
of an active substance in serum, i.e., the molecules derived from
this active substance following their intestinal absorption and
passage into the blood. After a single oral dose of 5g of
TOTUM•070, which is the clinical daily dose, used also in the HEART
clinical study (see below), analysis of the volunteers’ serum
confirmed the presence of 22 metabolites of interest, the majority
of which are known to have a biological activity on metabolism.
Kinetic measurements validated good bioavailability of these
metabolites in serum within three hours of oral TOTUM•070
intake.
In a second step, the serum collected from volunteers after oral
intake of 5g of TOTUM•070 – a serum rich in active metabolites from
TOTUM•070 – was used to conduct in vitro tests on human liver cells
exposed to massive lipid intake. In this context of “lipotoxic
stress”, the volunteers’ serum exerted two major effects on these
human liver cell lines: inhibition of the de novo cholesterol
synthesis pathway1 and inhibition of cholesterol storage. It also
showed no toxicity.
All analyses were conducted with a double control: cell cultures
with and without lipotoxic stress, then with and without serum
enriched in active metabolites.
Upcoming publication of the Phase II clinical results of
TOTUM•070 on hypercholesterolemia
The Phase II HEART clinical trial results will be announced in
the second quarter of 2022. This multi-center study will evaluate
the efficacy of TOTUM•070 in reducing blood LDL-cholesterol levels
versus placebo, in 120 volunteers with mild to moderate untreated
hypercholesterolemia. These results will be decisive for the
marketing of TOTUM•070, an innovative 100% plant-based active
substance containing neither phytosterols nor red yeast rice, and
for its positioning as a reference non-drug option against
LDL-cholesterol.
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
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
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.
1Cholesterol can be brought by food or produced by the body
itself ("de novo synthesis"). 2Molecules derived from TOTUM•070,
following their intestinal absorption and passage into the blood.
3The fraction of blood remaining after all blood cells (red blood
cells, leukocytes, platelets) and fibrinogen (a protein involved in
clotting) have been removed. 4ID-RCB: 2021-A01211-40
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Corporate communication / Valbiotis Carole ROCHER / Marc
DELAUNAY +33 5 46 28 62 58 media@valbiotis.com
Medias relations / PrPa Damien MAILLARD +33 6 80 28 47 70
damien.maillard@prpa.fr
Financial communication / Actifin Stéphane RUIZ +33 1 56 88 11
14 sruiz@actifin.fr
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