- The favourable opinion from the French Ethical Committee (CPP)
and the authorization from the French National Agency for the
Safety of Medicines and Health Products (ANSM) allow the
operational launch of REVERSE-IT, the last clinical development
phase of TOTUM-63.
- The REVERSE-IT study will be run under the scientific expertise
of Pr. Samy HADJADJ, diabetologist and endocrinologist at Nantes
University Hospital & Thorax Institute.
- This Phase II/III study, has been designed jointly with Nestlé
Health Science’s teams as part of the global strategic partnership
between both companies and is the latest phase of the development
of TOTUM-63.
- This international study will include 600 subjects with altered
glucose metabolism, spanning from elevated fasting glycemia to
early, yet untreated, Type 2 Diabetes. Its primary endpoint is
fasting glycemia.
- The first medical visit of the first patient applying to the
study will be the subject of an upcoming communication.
Regulatory News:
VALBIOTIS (FR0013254851 - ALVAL / PEA/SME eligible), a Research
& Development company committed to scientific innovation, for
preventing and combating metabolic diseases, announces the
favourable opinion issued from the French Ethical Committee (CPP)
and the authorization received from the French National Agency for
the Safety of Medicines and Health Products (ANSM) to launch the
international Phase II/III REVERSE-IT clinical study on TOTUM-63,
to reduce Type 2 Diabetes risk factors.
This clinical study primarily aims at confirming the Phase II
positive results previously obtained on the reduction of fasting
glycemia, a risk factor for developing Type 2 Diabetes, to obtain
health claims from American and European authorities. This study is
the latest phase of the development of TOTUM-63. TOTUM-63 is an
innovative active substance derived from plants, which has already
shown metabolic benefits in people with prediabetes. The CPP
favourable opinion and the ANSM authorization allow to initiate the
enrollments of 600 subjects with prediabetes and untreated Type 2
Diabetes (early stage) in the study.
Pr Samy HADJADJ, Diabetologist and Professor of Endocrinology
and Diabetology at Nantes University Hospital, scientific
expert of the study, comments: “From a prevention perspective,
it is essential to act on early stages of metabolic imbalance,
before the onset of Type 2 Diabetes or early at disease onset. This
is the purpose of the REVERSE-IT study, designed and sized to
establish the efficacy of this approach. To do so, we will assess
the impact of TOTUM-63 on the main metabolic risk factors for
developing Type 2 Diabetes, with particular attention to glycemic
parameters, abdominal obesity and body weight”.
Murielle CAZAUBIEL, Member of the Management Board, Director
of Development and Medical Affairs at VALBIOTIS, adds: "We are
satisfied to receive the CPP favourable opinion and the ANSM
authorization to start the REVERSE-IT clinical study, which will
complete the development of our active substance TOTUM-63. It is a
major clinical study, through its objective and methodology, to
validate our approach in the fight against Type 2 Diabetes. With
our teams and all our partners at our side, we are now eager to
carry it out, to offer all people with prediabetes the opportunity
to benefit from it."
The REVERSE-IT study follows the positive results of the Phase
II study on TOTUM-63, for the reduction of Type 2 Diabetes risk
factors. These results were published in 2019 (Press releases of
July 3 and September 2, 2019) and presented during the American
Diabetes Association scientific sessions in June 2020. The
REVERSE-IT study will take up the same primary endpoint (reduction
of fasting blood glucose level), the same tested dose (5g / day)
and the same regimen (three times a day during 6 months). It was
co-designed with the medical and regulatory teams of Nestlé Health
Science, as part of the global strategic partnership signed in
February 2020 for the development and marketing of TOTUM-63.
ABOUT TOTUM-63
TOTUM-63 is a unique and patented combination of 5 plant
extracts, with high potential to target the physiopathological
mechanisms of Type 2 Diabetes.
TOTUM-63 has already been proven safe and effective in healthy
human volunteers during a Phase I/II clinical study. The results of
the international randomized, placebo-controlled Phase II study
showed that TOTUM-63 reduced fasting and 2-hour blood sugar levels,
two risk factors for Type 2 Diabetes, in prediabetics compared to
placebo. In these subjects, who also had abdominal obesity,
TOTUM-63 significantly reduced body weight and waist
circumference.
TOTUM-63 benefits from intellectual property granted in the main
markets worldwide: Europe (covering 39 countries), the United
States, Russia and national phases are underway in more than 20
countries including China, Japan, Brazil, Australia. The ability to
produce TOTUM-63 industrially, in compliance to North American and
European standards, has been validated. TOTUM-63 already has
marketing authorizations related to its status in Europe.
In 2020, VALBIOTIS has signed a global and long-term partnership
with Nestlé Health Science for the development and worldwide
commercialization of TOTUM-63. This unique partnership in the field
of Nutrition Health plans that TOTUM-63 will be put on the market
by Nestlé Health Science at a global level, possibly before
obtaining a health claim, depending on the areas. It will also
provide funding for the latest development stages of TOTUM-63.
ABOUT NESTLE HEALTH SCIENCE
Nestlé Health Science (NHSc), a wholly-owned subsidiary of
Nestlé, is a globally recognized leader in the field of nutritional
science. At NHSc we are committed to empowering healthier lives
through nutrition for consumers, patients and their healthcare
partners. We offer an extensive consumer health portfolio of
industry-leading medical nutrition, consumer and VMS brands that
are science-based solutions covering all facets of health from
prevention, to maintenance, all the way through to treatment.
Headquartered in Switzerland, NHSc employs over 5’000 people around
the world, who are committed to making a difference in people’s
lives, for a healthier today and tomorrow.
For more information, please visit:
www.nestlehealthscience.com.
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 nutritional
health solutions designed to reduce the risk of major metabolic
diseases, based on a multi-target approach and made possible by the
use of plant-based ingredients.
Its products are intended to be licensed to players in the
health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has
formed numerous partnerships with top academic centers. The Company
has established three sites in France – Périgny, La Rochelle (17)
and Riom (63).
VALBIOTIS is a member of the "BPI Excellence" network and
received the "Innovative Company" status accorded by BPI France.
Valbiotis has also been awarded "Young Innovative Company" status
and has received major financial support from the European Union
for its research programs by obtaining support from the European
Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible
company.
Find out more about VALBIOTIS: www.valbiotis.com
Name: Valbiotis ISIN code: FR0013254851 Mnemonic code: ALVAL
DISCLAIMER
This press release contains forward-looking statements about
VALBIOTIS' objectives, based on rational hypotheses and the
information available to the company at the present time. However,
in no way does this constitute a guarantee of future performance,
and these projections can be reconsidered based on changes in
economic conditions and financial markets, as well as a certain
number of risks and doubts, including those described in the
VALBIOTIS core document, filed with the French Financial Markets
Regulator (AMF) on 31 July 2019 (application number R19-030) as
well in its supplement approved by the AMF on Octobre 9, 2019.
These documents being available on the Company’s website
(www.valbiotis.com). This press release, as well as the information
contained herein, does not constitute an offer to sell or subscribe
to, or a solicitation to purchase or subscribe to, VALBIOTIS'
shares or securities in any country.
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version on businesswire.com: https://www.businesswire.com/news/home/20200707005886/en/
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
MEDIA RELATIONS / MADIS PHILEO Guillaume DE CHAMISSO +33 6 85 91
32 56 guillaume.dechamisso@madisphileo.com
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