- This randomized, placebo-controlled Phase II clinical study
with TOTUM•070 achieved its objective of reducing LDL cholesterol
(primary endpoint) and confirmed the very good tolerance of this
active substance.
- As early as 3 months of supplementation, the results showed a
significant reduction in blood levels of LDL cholesterol (-13%) and
triglycerides (-14%).
- Comprehensive data from the HEART study will be presented at
international scientific conferences.
- TOTUM•070 covers the unmet need for the management of untreated
mild to moderate hypercholesterolemia and addresses the
expectations expressed by patients and healthcare professionals in
the market studies1 conducted by Valbiotis.
- Valbiotis sets the objective of commercialization based on
these Phase II results, no later than the first half of 2024, and
is intensifying its discussions with major health and nutrition
players.
- Hypercholesterolemia is one of the major and most widespread
cardiovascular risk factors, with a prevalence of 39% in the adult
population worldwide, 48% in North America, 54% in Europe2, and 62%
in France3, i.e., 174 million adults in the United States and the 5
major European countries alone4.
Regulatory News:
Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a Research
and Development company committed to scientific innovation for
preventing and combating metabolic diseases, announces the major
success of the Phase II HEART clinical study, which achieved its
objective of reducing blood LDL cholesterol level (primary
endpoint) with TOTUM•070 and confirmed the very good tolerance of
this active substance. This multicentric, randomized,
placebo-controlled, double-blind study was conducted in 120
volunteers with mild to moderate untreated hypercholesterolemia and
tested a daily dose of 5 g in two intakes for 6 months. As early as
three months of supplementation, TOTUM•070 significantly reduced
blood levels of LDL cholesterol (-13%, p<0.01), and
triglycerides (-14%, p<0.05), compared to placebo. Excess of
these blood lipid markers is a cardiovascular risk factor.
Thanks to these very good clinical results, TOTUM•070, an
innovative patented active substance derived from food plant
extracts, without phytosterols or red yeast rice, becomes a
clinically proven non-drug option for people with untreated mild to
moderate LDL hypercholesterolemia, as a complement to lifestyle and
dietary recommendations.
Sébastien PELTIER, Chairman of the Board of Directors at
Valbiotis, comments: "This clinical success exceeds our
expectations, as it shows a significant reduction in LDL
cholesterol, our primary objective, as well as blood triglycerides,
which are associated with cardiovascular risk. Given these positive
results, the quality of the scientific data already obtained and
the need for solutions for untreated patients, we have decided to
market TOTUM•070 after these Phase II results. In this perspective,
we are already engaged in the search for commercial partnerships
with a commercialization horizon no later than the first half of
2024. The TOTUM•070 scientific package, combined with our market
studies with patients and healthcare professionals, supports this
ambition. At the same time, we will be preparing a final Phase
II/III clinical step to obtain a health claim that will enhance the
value of this active substance."
Results of the Phase II HEART clinical study
The HEART clinical study was a multicentric, international,
randomized, placebo-controlled, double-blind study involving 120
people with untreated mild to moderate hypercholesterolemia, with
blood level of LDL cholesterol between 130 mg/dl and 190 mg/dl. The
participants were divided into two equivalent arms of 60 people,
supplemented for six months with a daily dose of 5 g of TOTUM•070
or a placebo, in two intakes.
After a 6-month supplementation, the study achieved its
objective of significantly reducing LDL cholesterol in the blood
(primary endpoint, -9% versus placebo, p<0,015). As early as 3
months of supplementation with TOTUM•070, the results showed a
significant lipid-lowering effect, with:
- a significant 13% reduction in blood LDL cholesterol level,
compared to placebo (p<0.015);
- a significant 14% reduction in blood triglyceride level,
compared to placebo (p<0.055).
In clinical practice, the reduction of LDL blood cholesterol as
early as 3 months of supplementation is an expected benefit by
patients and healthcare professionals1. The HEART study also
demonstrates the persistent lipid-lowering effect at 6 months.
In addition, the study confirmed the safety and very good
tolerance of TOTUM•070.
The comprehensive data from the study will be presented at
international scientific conferences.
Prof. Jean-Marie BARD, professor of biochemistry and pharmacy
hospital practitioner at Nantes University Hospital and at the West
Institute of Cancerology (Institut de Cancérologie de l'Ouest),
scientific advisor of the HEART study, comments: "The results of
the HEART study are very positive. They demonstrate the efficacy of
TOTUM•070 on blood LDL cholesterol, a well-known cardiovascular
risk factor, and a lipid-lowering effect on triglycerides,
associated with cardiovascular risk. The study also confirms the
very good tolerance of this active substance: this is an important
issue in lipid-lowering strategies, as emphasized by international
learned societies. With these data, TOTUM•070 is therefore a very
good solution to address the lack of reliable options adapted to
mild to moderate hypercholesterolemia, for which only lifestyle and
dietary recommendations are currently proposed."
Murielle CAZAUBIEL, Head of Development, Medical, Regulatory and
Industrial Affairs, member of Valbiotis Board of Directors, adds:
"These results exceed the ambitions we had announced for TOTUM•070.
It was a challenge to demonstrate the relevance of a plant-based
active substance in such a demanding clinical field, in line with
the preclinical data we had already published. This has been
achieved. We are very proud of this achievement and would like to
thank all the people involved in this study, both professionals and
volunteers: thanks to them, TOTUM•070 is now a clinically proven
and well-tolerated non-drug option against high cholesterol, in the
context of cardiovascular risk prevention."
The efficacy and mode of action data
previously obtained for TOTUM•070
The results of the HEART clinical study are consistent with the
preclinical efficacy data already obtained in dyslipidemia models
and presented at the American Heart Association meeting in 2021.
This work showed a significant dose-dependent reduction in LDL
cholesterol and triglycerides.
In addition, clinical and preclinical studies (positive clinical
results published March 29, 2022) have documented the multi-target
mode of action of TOTUM•070. According to these data, the
lipid-lowering effect of TOTUM•070 is based:
- at the intestinal level, on the reduction of the absorption of
cholesterol;
- at the hepatic level, on the reduction of de novo6 cholesterol
synthesis.
In these studies, additional liver benefits were observed, with
a decrease in cholesterol storage and a decrease in gene expression
of inflammatory markers.
Targeting the marketing of the product by the first half of
2024 at the latest
Given the need for clinically proven non-drug options, as
highlighted by market studies with patients and healthcare
professionals, the Company sets the objective of commercialization
no later than the first half of 2024, based on all of these Phase
II results, and is intensifying its discussions with major players
in the health and nutrition sectors.
Following the finalization of the industrial scale-up, TOTUM•070
will be offered in two galenic forms (capsules or powder for
dilution), to be taken twice daily. It will be available over the
counter in pharmacies (pharmacy stores or online) for patients and
consumers. Available without a prescription, TOTUM•070 may be
advised by healthcare professionals.
From a regulatory standpoint, TOTUM•070 can already be marketed
in Europe, after notification to the DGCCRF in France (mutual
recognition applicable for other European Union countries).
Regulatory processes for North America and other areas are
ongoing.
Mild to moderate hypercholesterolemia: patients and
physicians awaiting solutions
Excess blood LDL cholesterol is the primary cause of
atherosclerosis, a serious disease of the arteries with
debilitating and potentially deadly cardiovascular complications
(stroke, heart attack, arterial diseases, amongst others). Given
the risk, hypercholesterolemia must be managed according to
international guidelines, to reduce blood LDL cholesterol
levels.
How is it managed?
Other than essential lifestyle changes, therapeutic strategies
are defined for each patient following an assessment of their
overall cardiovascular risk level: smoking, blood pressure,
overweight, age, individual and family history, amongst others.
- For the most at-risk patients, long-term drug treatments (such
as statins) are recommended and effective.
- For patients with moderate hypercholesterolemia or a lower
overall risk, the initiation of these treatments is discussed
between the physician and the patient depending on their
benefit/risk ratio.
- For patients with a mild form and a moderate risk, the
benefit/risk ratio of the treatment is unfavorable.
A real need for solutions for patients at
moderate risk
Between lifestyle-dietary rules alone and long-term treatments,
there is a lack of effective, well-tolerated intermediary solutions
for managing cholesterolemia, preventing it from worsening, and
delaying the initiation of treatment. Confronted with this need
expressed by physicians and their patients, international
guidelines recognize the potential benefit of non-drug products -
in particular food - but highlight the lack of clinical proof so
far.
A world with high cholesterol
And yet the epidemiological data is worrying: according to the
WHO, hypercholesterolemia affects 39% of adults in total worldwide
with its prevalence reaching 54% in Europe and 48% in North
America2.
In France, 62% of adults have a total cholesterol level above
2.0 g/l3.
Overall, it is estimated that 174 million adults in the United
States and the 5 major European countries have excessive LDL
cholesterol levels4.
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 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 Mnemonic code: 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
(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.
___________________ 1 Market studies conducted by IFOP and A+A
institutes for Valbiotis in 2022 2 Global Health Observatory, WHO
(2018, data 2008) 3 Wilkins E et al., European Cardiovascular
Disease Statistics 2017. European Heart Network, Brussels 4 AEC
Partners, Elevated LDL cholesterol preliminary market estimation,
2020 5 Intention-to-treat analysis (ITT) 6 Cholesterol can be
supplied by the diet or produced by the body itself ("de novo
synthesis").
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220613005630/en/
Corporate communication / Valbiotis Carole ROCHER Communication
and Public Affairs Director +33 6 77 82 56 88
Marc DELAUNAY Communication Manager +33 5 46 28 62 58
media@valbiotis.com
Financial communication / Actifin Stéphane RUIZ Associate
Director +33 1 56 88 11 14 sruiz@actifin.fr
Media Relations / PrPa Damien MAILLARD Operational Director +33
6 80 28 47 70 damien.maillard@prpa.fr
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