- This last pivotal trial (REVERSE-IT), has been designed jointly
with Nestlé Health Science’s teams and will be entirely funded by
the partnership agreement;
- This international trial will include 600 participants and
should be launched before mid-2020;
- Its first objective is to confirm the positive results of the
Phase II clinical trial on fasting blood sugar levels, a
well-established risk factor for developing Type 2 Diabetes, to
obtain strong health claims;
- The trial aims to include a broad population with altered
glucose metabolism, spanning from elevated fasting glucose to early
(yet untreated) Type 2 Diabetes.
Regulatory News:
VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME
eligible), a Research & Development company committed to
scientific innovation for preventing and combating metabolic
diseases, announces today, that as part of its global partnership
with Nestlé Health Science, it is launching the pivotal late stage
development phase of TOTUM-63, a plant-derived active substance
with clinically demonstrated metabolic health benefits on people
with prediabetes.
This last phase of the clinical development was co-designed with
Nestlé Health Science's medical and regulatory teams and consists
of one pivotal Phase II/III clinical study, called REVERSE-IT. This
clinical trial will include people with prediabetes and with early
stage untreated Type 2 Diabetes. It will pursue two main strategic
objectives:
- Replicate the previous Phase II positive result on fasting
blood sugar levels, a well-established risk factor for developing
Type 2 Diabetes;
- Extend the evaluation of TOTUM-63 to patients with early stage
untreated Type 2 Diabetes, to enlarge the final target
population.
The launch of the REVERSE-IT trial is planned for the first half
of 2020. In order to rapidly complete the recruitment, the trial
will be led in more than 30 international clinical centers. It will
be entirely funded by the partnership signed in February 2020 with
Nestlé Health Science.
Murielle CAZAUBIEL, Head of Development and Medical Affairs,
states: “The REVERSE-IT study results from the combined expertise
of VALBIOTIS and Nestlé Health Science. We have strong ambitions
for this last regulatory clinical phase, that are based on the very
good results we obtained in the previous Phase II clinical trial.
Considering the resources we mobilize, we can reasonably expect the
topline data to be released before mid-2022. We feel enthusiastic
for this final step of our innovative R&D process and we are
confident in the fact that it will get TOTUM-63 to wide and
successful commercialization, which may take place before obtaining
health claims.”
Hans-Juergen WOERLE, Chief Scientific & Medical Officer of
Nestlé Health Science, adds: “The scope and conditions of this
clinical trial are significant: it is being led in 30 international
clinical settings with 600 participants. The thoroughness of this
trial will provide results that are extremely useful in
demonstrating a safe and effective opportunity to help patients who
have prediabetes and Type 2 Diabetes."
The REVERSE-IT trial will be randomized and placebo-controlled,
with the same primary objective (reduction in fasting glycemia),
the same duration of supplementation (6 months) and the same tested
dose (5g/day) and regimen (three times per day) than the previous
Phase II study, which positive results were published in 2019
(Press releases, 3rd July 2019 and 2nd September 2019).
The study population will include 600 subjects with abnormally
elevated fasting blood glucose (dysglycemia) and abdominal obesity,
two frequently associated conditions. The number of subjects
included will guarantee the robustness of this pivotal trial.
Led in a wider population, this trial will also pursue larger
clinical objectives, with a three-arm design. The regimen of three
doses per day, for a total daily dose of 5g, will be tested against
placebo (200 subjects receiving TOTUM-63 in one arm and 200
subjects receiving a placebo in the second arm). The primary
criterion is the reduction in fasting blood glucose against
placebo, with this three doses per day regimen. A third open label
arm will test a regimen of two doses per day, for the same total
daily dose of 5g, on 200 subjects.
The trial will evaluate several other metabolic criteria of high
interest for people with prediabetes or early stage untreated Type
2 Diabetes.
The partnership with Nestlé Health Science also plans an adjunct
clinical study to obtain exploratory data on TOTUM-63 mode of
action in humans.
VALBIOTIS will provide details on its other products in a
subsequent communication.
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 clinical 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200401005658/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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