Valbiotis Announces the Completion of Recruitment for the Phase II HEART Clinical Study Conducted With TOTUM•070 in Hypercholesterolemia, a Risk Factor for Cardiovascular Disease
06 Septembre 2021 - 5:40PM
Business Wire
- Recruitment of the last volunteer, randomized at the beginning
of September 2021, confirms the announced schedule of the HEART
clinical study, the results of which will be available in the
second quarter of 2022.
- The multicenter, randomized, placebo-controlled HEART clinical
study is designed to evaluate the efficacy of TOTUM•070 in 120
people with mild to moderate untreated hypercholesterolemia.
- The primary endpoint of the study is the reduction in blood
LDL-cholesterol levels, a risk factor for cardiovascular disease
and the main risk factor for atherosclerosis1.
- The HEART study is a key step in the development of TOTUM•070
and in the commercialization strategy on the non-drug
hypercholesterolemia market, estimated at 1.2 billion euros in
Europe and the USA2.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible), a French
research and development company committed to scientific innovation
for preventing and combating metabolic diseases, announces that it
has completed the recruitment of 120 volunteers for the Phase II
HEART clinical study at the beginning of September 2021, in
accordance with the schedule announced by the Company. In line with
its development plan, Valbiotis confirms that the results of the
HEART study will be available in the second quarter of 2022.
The HEART clinical study is a multicenter, international,
randomized, placebo-controlled, double-blind study involving 120
people with untreated moderate hypercholesterolemia between 130 and
190 mg/dL. Participants are divided into two equivalent arms of 60
people, supplemented for 6 months with TOTUM•070 or placebo. The
primary endpoint of the HEART study is the reduction of blood
LDL-cholesterol levels, a risk factor for cardiovascular disease
and in particular atherosclerosis, and it has several secondary
objectives of interest.
Murielle CAZAUBIEL, Head of Development, Medical, Regulatory and
Industrial Affairs, member of the Valbiotis Board of Directors,
comments: "We are completing enrollment in the HEART clinical study
and we are delighted with the progress of this study and look
forward to seeing the results in a few months. The medical need is
real: according to the WHO, nearly 40% of the world's adult
population has high cholesterol, a well-known cardiovascular risk
factor. High-risk patients are generally treated with drug-based
approaches. But for more moderate forms, there is a lack of a
non-drug, open-label, clinically proven option to reduce excess
blood LDL-cholesterol before it becomes too high risk. We are
developing TOTUM•070 to bring this preventive option to as many
people as possible."
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.
Once development is completed, TOTUM•070 will be indicated for
people with LDL-hypercholesterolemia, for levels up to 190 mg/dL,
with a moderate overall cardiovascular risk. TOTUM•070 could be
recommended in this large population for whom no first-line drug
treatment is currently recommended (see press release of October
27, 2020).
Sébastien BESSY, Head of Marketing and Commercial Operations,
member of the Valbiotis Board of Directors, states: "The HEART
clinical study is a key element in the marketing strategy: it is
designed to demonstrate the efficacy of our active substance
TOTUM•070 for people at risk who are not currently receiving
treatment. The market for untreated hypercholesterolemia is already
very significant and is worth 1.2 billion euros in Europe and the
United States2. In these vast markets, the success of HEART would
give TOTUM•070 a decisive advantage with consumers."
Untreated hypercholesterolemia: the large market of non-drug
products
In the 5 major European countries (France, Germany, Italy,
Spain, United Kingdom) and the United States, an estimated 174
million adults have elevated LDL-cholesterol levels2,3. Thanks to a
high diagnosis rate, approaching 50%, the diagnosed population is
83 million people2.
However, in accordance with the recommendations, only people at
high overall cardiovascular risk are treated. A large proportion of
those diagnosed are therefore already turning to non-drug products,
notably in the USA (54% of people diagnosed), the UK (58%), France
(34%) and Germany (35%)2. The market for these LDL-cholesterol
lowering products is today estimated at nearly €1.2 billion in
these regions, including more than €600 million in the United
States2.
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, based on a multi-target approach enabled by the use of
plant-based ingredients. 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.
12018 Guideline on the Management of Blood Cholesterol, a report
from the American College of Cardiology / American Heart
Association, Journal Of The American College Of Cardiology, 2019.
2AEC Partners data, 2019, for Valbiotis. 3Blood LDL-cholesterol
level greater than 100 or 130 mg/dL, depending on available
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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