Valbiotis Announces That It Has Submitted to the Competent Authorities the Three Clinical Protocols for TOTUM•854 Indicated in the Reduction of Blood Pressure and Presents Its Comprehensive Clinical Development Plan
01 Décembre 2021 - 7:35AM
Business Wire
- The INSIGHT international, multicenter, randomized,
placebo-controlled pivotal Phase II/III clinical study will be
conducted with a 3.7 g/day dose of TOTUM•854 on 400
volunteers;
- The INSIGHT 2 international, multicenter, randomized,
placebo-controlled Phase II/III clinical study will be conducted
with a 2.6 g/day dose of TOTUM•854 on 400 volunteers;
- The clinical study of the bioavailability and mode of action of
TOTUM•854, to characterize its metabolites and identify their
effects on human cell lines, will be conducted in France on 10
volunteers.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) (Paris:AVAL),
a Research and Development company committed to scientific
innovation for preventing and combating metabolic and
cardiovascular diseases, announces that it has submitted the three
clinical protocols for TOTUM•854, indicated in the reduction of
blood pressure, to the competent authorities and presents its
comprehensive clinical development plan, as announced at the annual
meeting of the European Society of Hypertension and of the
International Society of Hypertension in April 2021 (Press release
dated April 12, 2021).
TOTUM•854 is the second plant-based active substance from the
Valbiotis product portfolio to enter Phase II/III clinical trials
and will address an unmet medical demand for non-drug prevention of
arterial hypertension.
The TOTUM•854 clinical development program includes three
clinical studies, whose results will be required in Europe and the
United States for health claim applications in the reduction of
blood pressure, which is a risk factor for cardiovascular disease.
The clinical protocols for the three studies have been filed with
the competent authorities.
The INSIGHT international, multicenter, randomized,
placebo-controlled Phase II/III clinical study will be conducted in
a population of 400 volunteers with mild to moderate blood pressure
elevation (systolic blood pressure between 130 mmHg and 159 mmHg
and diastolic pressure <100 mmHg). It will include two groups: a
TOTUM•854 group with a dose of 3.7 g/day and a placebo group. Its
main objective will be to reduce systolic blood pressure in the
TOTUM•854 group after 3 months of supplementation versus the
placebo group. 24-hour ambulatory blood pressure measurements will
also be taken as a secondary study endpoint. The end of recruitment
is expected at the first semester of 2023.
A second INSIGHT 2 international, multicenter, randomized,
placebo-controlled study will be conducted on 400 additional
subjects with the same inclusion criteria. It will include two
groups: a TOTUM•854 group with a dose of 2.6 g/day and a placebo
group. Its main objective will be to reduce systolic blood pressure
in the TOTUM•854 group after 3 months of supplementation versus the
placebo group. It will thus assess the effect of a reduced dose of
TOTUM•854 (2.6 g/day) on blood pressure. The end of recruitment is
expected at the first semester of 2023.
The clinical study of the bioavailability and mode of action of
TOTUM•854, to characterize its metabolites and identify their
effects on human cell lines, will be conducted in France on 10
volunteers. The results are expected at the end of 2022.
Murielle CAZAUBIEL, Member of the Board of Directors and
Director of Medical, Regulatory and Industrial Affairs at
Valbiotis, said: “TOTUM•854’s clinical development plan is very
ambitious, but meets the health challenges of preventing arterial
hypertension, which the World Health Organization considers to be
the world’s most prevalent chronic disease. It is a very important
risk factor for cardiovascular disease. TOTUM•854 could quickly
become an extremely interesting non-drug alternative for people at
risk, whether or not they are already taking treatment. This
innovative active substance, which contains six plant extracts, is
designed to act on blood pressure regulation mechanisms. It would
ultimately be produced in various dry forms, including as
capsules.”
Sébastien BESSY, Member of the Board of Directors and Chief
Operating Marketing and Business Officer at Valbiotis, comments:
“TOTUM•854 will open the door to a major market worth over €1.15
billion1 in the United States and in the five main European
countries (Germany, Spain, France, Italy and the United Kingdom),
where no fewer than 124 million people suffer from mild to moderate
arterial hypertension. This clinical development plan will leverage
the potential of TOTUM•854 in preventing arterial hypertension,
with the aim of bringing it to market as soon as the studies ends.
In addition, we have registered TOTUM•854 in over 60 countries,
including our key territories such as the United States, Europe,
Mexico, China, Japan and already obtained in some of these
territories.”
Valbiotis presented its preclinical data on the active substance
TOTUM•854 at the annual meeting of the European Society of
Hypertension and of the International Society of Hypertension in
April 2021. The in vivo results obtained from two predictive models
of hypertension in humans showed that TOTUM•854 effectively
prevented arterial hypertension. This proof-of-concept was obtained
in partnership with the Cardiovascular Pharm-Ecology Lab (LaPEC) of
the University of Avignon and at the Valbiotis R&D platform.
The research presented at the meeting was conducted on a model of
L-NAME-induced hypertension (an NO synthase inhibitor). In this
classic model of hypertension, predictive of human physiology,
TOTUM•854 prevented the onset of arterial hypertension compared
with the control group. Additional data, obtained from a polygenic
SHR (spontaneously hypertensive rat) model of hypertension, also
showed a positive effect of TOTUM•854 that delays the development
of hypertension.
A significant acute effect was also observed following a single
dose of TOTUM•854 on the same SHR model.
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
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.
1Source: AEC Partners pre-AHT preliminary market estimate 2020
data
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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
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