- TOTUM•854 protects human cells of the vascular wall,
particularly against inflammation and oxidative stress, which is
key to preventing worsening of high blood pressure.
- TOTUM•854 also reduces angiotensin I-converting enzyme (ACE1)
activity, one of the main modes of action known to reduce blood
pressure.
- The bioavailability study also confirms the presence of 10
metabolites of interest in human serum after oral administration of
3.7 g of TOTUM•854, the daily clinical dose used in the Phase
II/III INSIGHT clinical study.
- In line with the preclinical data, these very strong results
confirm the potential of TOTUM•854 against mild to moderate high
blood pressure in humans and provide strong prospects for late
clinical development.
- With a view to marketing TOTUM•854, Valbiotis is targeting the
signature of international partnerships and will market directly on
the French market; the market for mild to moderate high blood
pressure currently includes 123 million adults in the United States
and Europe1.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible)
(Paris:ALVAL), a commercially oriented Research and Development
company, with a commercial purpose, committed to scientific
innovation for preventing and combating metabolic and
cardiovascular diseases, announces positive results in the
bioavailability and mode of action clinical study conducted on
TOTUM•854 against high blood pressure, the number one
cardiovascular risk factor worldwide. The mode of action results
demonstrate a protective effect of TOTUM•854 on vascular wall cells
and a reduction in angiotensin I-converting enzyme (ACE1) activity
in humans. These robust data confirm the potential of TOTUM•854 to
reduce blood pressure at the earliest stages of arterial
hypertension, which affect 123 million people in the US and
Europe1. They hold great promise for the late-stage clinical
development of TOTUM•854.
Pascal SIRVENT, Director of Discovery and Preclinical and
Translational Research, member of the Executive Committee,
comments: "These innovative bioavailability and mode of action
studies once again demonstrate their scientific value for the
development of our plant-based active substances. In line with our
preclinical work, we can now confirm that TOTUM•854 preserves the
integrity of the cells of the blood vessel wall, more specifically
of its endothelium. Damage to the vascular wall is a major
mechanism in the progression of high blood pressure. Moreover, we
also discovered that this active substance acts on the angiotensin
pathway, a well-known target of anti-hypertensive strategies. This
first-in-human evidence confirms the relevance of TOTUM•854's
positioning in the early stages of the disease and bodes well for
the ongoing Phase II/III clinical efficacy studies in high blood
pressure."
TOTUM•854, a patented active substance based on a combination of
plant extracts, is developed to reduce blood pressure in people
with mild to moderate hypertension, a risk factor for
cardiovascular disease.
Mild to moderate arterial hypertension now affects 123 million
adults in the United States and the 5 major European countries1. No
non-drug product has strong clinical evidence or a specific health
claim.
TOTUM•854 is currently in the final phase of clinical
development before being marketed. Valbiotis aims to sign one or
more international commercial partnerships while it will market
this active substance in France itself, in accordance with the
strategy announced on October 7, 2022 (press release of October 7,
2022). TOTUM•854 will be marketed in two stages. The first step
will be based on the recommendation by healthcare professionals,
thanks to the Phase II/III results. In a second step, obtaining a
proprietary health claim will strengthen the medical positioning of
TOTUM•854, especially with patients/consumers.
Enrollment in the first Phase II/III clinical trial (INSIGHT
study) is expected to be completed by half-year 2023.
Results of the bioavailability and mode of action clinical study
on TOTUM•854
The TOTUM•854 bioavailability and mode of action clinical study,
conducted in 10 healthy volunteers, first confirmed the presence of
10 metabolites of interest2, mainly polyphenolic compounds, in
volunteers' serum3. These analyses were performed after taking 3.7
g of TOTUM•854 orally, the daily clinical dose also used in the
Phase II/III INSIGHT clinical study.
Ex vivo mode of action analyses then demonstrated a triple
protective effect of these metabolites on human blood vessel wall
cells (endothelial cells):
- increased resistance and viability of these cells to stress
induced by excess lipids;
- strong protection against inflammatory processes, with a
significant decrease in the production of pro-inflammatory agents
such as interleukin 1-ß (IL1-ß) and in the expression of MCP-1 and
VCAM-2 markers;
- protection against oxidative stress with a decrease in the
concentration of free radicals and a reduced expression of the Nox2
enzyme.
Mode of action tests also revealed a reduction in angiotensin
I-converting enzyme (ACE1) activity, an enzyme well known in the
pathophysiology of high blood pressure.
This protective effect on the vascular wall in humans confirms
the data already obtained in preclinical studies and presented at
the annual meetings of the American Heart Association (AHA), the
European Society of Cardiology (ESC) and the European Society of
Hypertension (ESH) in 2022. Above all, it confirms the preventive
positioning of TOTUM•854 in the early stages of high blood
pressure. In the initial phases of the disease, when blood pressure
rises, the vascular wall undergoes damage involving inflammation
and oxidative stress. Ultimately, these changes lead to the
narrowing of blood vessels: hypertension worsens, becomes chronic
and requires long-term pharmacological treatment. Protection of the
vascular wall is therefore a major challenge in the management of
early high blood pressure, in order to prevent the progression of
the condition.
The innovative protocol of the TOTUM•854 bioavailability and
mode of action clinical study
The study was conducted on 10 healthy volunteers in an
open-label setting and followed a protocol combining metabolomics
and mode of action. Prof. Gisèle PICKERING, coordinator of the
Clinical Investigation Center at Clermont-Ferrand University
Hospital, was the principal investigator4.
Metabolomic analysis consists of characterizing the metabolites
of an active substance in serum, i.e., the molecules derived from
this active substance after their intestinal absorption and their
passage into the blood. After a single oral intake of 3.7 g of
TOTUM•854, the daily clinical dose also used in the INSIGHT Phase
II/III clinical study, analysis of the volunteers' serum confirmed
the presence of 10 metabolites of interest, polyphenolic compounds
mostly known to exert biological activity on metabolism. Kinetic
measurements confirmed good bioavailability of these metabolites in
serum within three hours after oral administration of
TOTUM•854.
In a second step, serum from volunteers was collected after oral
intake of 3.7 g TOTUM•854. This serum rich in active metabolites
was used to conduct in vitro mode of action tests on human
umbilical vein endothelial cells (HUVECs), exposed to massive lipid
intake, or lipotoxic stress, generating inflammation and oxidative
stress.
About Valbiotis
Valbiotis is a commercially oriented 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.
Internationally, its products are intended to be the subject of
licensing or distribution agreements with global and regional
health and nutrition players. In France, Valbiotis will be
responsible for marketing its own products.
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
filed to the French Financial Markets Regulator (AMF) on May 19,
2022, and completed by an amendment on November 8, 2022. 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.
1Elevated LDL, pre-HTA and NAFL preliminary market estimation,
AEC Partners, 2020. 2Molecules from TOTUM•854, after they have been
absorbed from the intestine and passed into the bloodstream. 3The
fraction of blood remaining after all blood cells (red blood cells,
leukocytes, platelets) and fibrinogen (a protein involved in
coagulation) have been removed. 4ID-RCB: 2021-A02695-36
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230130005310/en/
Corporate communication / Valbiotis Carole ROCHER Communications
and Public Affairs Director + 33 6 77 82 56 88
Marc DELAUNAY Communication Manager media@valbiotis.com
Financial communication / Seitosei Actifin Stéphane Ruiz
Associate Director +33 1 56 88 11 14 sruiz@actifin.fr
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