- The study achieved its objective on the primary endpoint, the
reduction of fasting blood glucose, a risk factor for type 2
diabetes, at a 5g daily dose in 3 intakes per day, with a high
statistical significance.
- The endpoint of fasting blood glucose reduction was also
achieved with a high level of statistical significance at a similar
dose, but in two intakes per day, acknowledging the efficacy of
this regimen.
- This clinical success triggers a lump sum payment of CHF 4
million from Nestlé Health Science, as part of the global strategic
partnership on TOTUM•63.
- Unequivocal clinical efficacy of TOTUM•63 validates Valbiotis'
scientific approach, based on the use of innovative and patented
combinations of plant-based active ingredients for the prevention
of metabolic and cardiovascular diseases.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible)
(Paris:ALVAL), a commercially oriented Research and Development
company committed to scientific innovation for preventing and
combating metabolic and cardiovascular diseases, announces the
large success of the REVERSE-IT Phase II/III clinical study on
TOTUM•63. Conducted in 636 prediabetic and untreated type 2
diabetic patients (early stage), this international, multicentric,
randomized and placebo-controlled study confirms the efficacy of
TOTUM•63 in reducing fasting blood glucose at 2 and 3 intakes per
day. These positive results trigger a lump sum payment of CHF 4
million from Nestlé Health Science as part of the global strategic
partnership.
Sébastien PELTIER, co-founder and Chairman of the Valbiotis
Executive Committee, comments: "I am extremely proud of the results
of the REVERSE-IT study on TOTUM•63, which represent a major
breakthrough in the fight against diabetes and its complications
for people with prediabetes and untreated type 2 diabetes (early
stage). We have provided unequivocal clinical evidence that
TOTUM•63 is a promising solution for millions of people worldwide,
helping to prevent the progression to type 2 diabetes. This is a
groundbreaking and exciting moment for our company, and I would
like to extend my warmest thanks to our employees, our partners
including Nestlé Health Science, and especially to the patients who
participated in this study. Together, we have accomplished
something truly remarkable, and we are determined to continue our
mission to develop innovative solutions to improve the health of
people around the world. Beyond this great achievement, which opens
up a new path, it is also a personal satisfaction, after almost 10
years of hard work."
Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer
at Nestlé Health Science, comments: "We are thrilled with the
completion of this large clinical study, gathering more than 600
patients, designed to rigorously evaluate TOTUM•63. This non-drug,
plant-based active substance has the potential to significantly
impact the management of early impairments of glucose
metabolism."
Jean-Marie BARD, emeritus professor of biochemistry and hospital
practitioner in pharmacy, scientific advisor of the REVERSE-IT
study, President of the French Nutrition Society Scientific
Committee, specifies: "With more than 600 patients included in more
than 50 centers internationally, REVERSE-IT is one of the largest
and most ambitious studies in the world with non-drug approaches to
early dysglycemia, from prediabetes to the early stages of type 2
diabetes. The results of this study represent a significant
breakthrough for these people with glycemic impairment and confirm
the data already obtained in 2019 with the Phase II study,
published in the journal Diabetes, Obesity and Metabolism in 2022.
I am delighted to have participated in the clinical validation of
this new approach. Many healthcare professionals will be able to
provide a solution for their patients and change their clinical
practices, which until now have been limited to lifestyle
recommendations alone."
The REVERSE-IT study was co-designed with Nestlé Health
Science's medical teams as part of the global strategic partnership
between Valbiotis and Nestlé Health Science signed in February
2020. Under this agreement, positive results of the REVERSE-IT
study on the primary endpoint trigger a lump sum payment of CHF 4
million from Nestlé Health Science to Valbiotis. This milestone
payment from Nestlé Health Science will occur upon submission of
the full study report during the summer.
The REVERSE-IT study and its results on its primary endpoint
The randomized and placebo-controlled REVERSE-IT Phase II/III
study included 636 people with impaired glucose metabolism, ranging
from prediabetes to untreated type 2 diabetes (early stage).
The volunteers were divided into three equally balanced arms,
each with more than 200 participants. In the intervention arm,
participants were supplemented with TOTUM•63 at a dose of 5 g/day
in three daily intakes. To complete the study, a second open-label
arm evaluated a similar dose of 5 g of TOTUM•63 in two daily
intakes.
The REVERSE-IT study met its two objectives on its primary
endpoint, fasting blood glucose, with a high statistical
significance on the data obtained in ITT (Intention To Treat):
- the reduction in fasting blood glucose with TOTUM•63 after 6
months of supplementation with a 5g/day dose in three daily
intakes, compared to placebo (p=0.015);
- the reduction in fasting blood glucose with TOTUM•63 after 6
months of supplementation with a 5g/day dose in two daily intakes,
compared to placebo.
The statistical analysis conducted in the per protocol
population also confirms the statistical significance of these two
results.
At the end of all the analyses, the comprehensive results of the
study will be communicated in a subsequent press release, on the
secondary endpoints and exploratory analysis, and submitted for
presentation at international congresses and publication in
international peer-reviewed journals.
About TOTUM•63
TOTUM•63 is a unique and patented combination of 5 plant
extracts that targets the pathophysiological mechanisms of type 2
diabetes. TOTUM•63 benefits from intellectual property validated by
patents in the world's leading markets: Europe (covering 39
countries), the United States, Russia, China, Japan, Mexico,
Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi
Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India, South
Korea and national phases are currently ongoing in Brazil,
Argentina, Canada, Thailand, Qatar and the United Arab Emirates
Production capacity for TOTUM•63 has been validated in accordance
with North American and European standards. TOTUM•63 already has
marketing authorizations related to its status in Europe. In
February 2020, Valbiotis signed a long-term global strategic
partnership with Nestlé Health Science for the development and
worldwide commercialization of TOTUM•63. This unique partnership in
the field of Health Nutrition foresees the marketing of TOTUM•63 by
Nestlé Health Science on a global scale, possibly before obtaining
a medical clearance depending on the area. They will also fund the
final stages of development of TOTUM•63.
About Valbiotis
Valbiotis is a commercially oriented Research & Development
company, committed to scientific innovation forpreventing 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. Internationally, its products are intended to be the
subject of licensing and/or distribution agreements with global or
regional health and nutrition players. In France, Valbiotis will be
responsible for marketing its own products. 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 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
filed to the French Financial Markets Regulator (AMF) on April 26,
2023. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230522005409/en/
Corporate Communication / Valbiotis Carole ROCHER Communication
and Public Affairs Director + 33 6 77 82 56 88
Marc DELAUNAY Communication Manager media@valbiotis.com
Financial communication / Seitosei Actifin Stéphane RUIZ
Associate Director +33 1 56 88 11 14 sruiz@actifin.fr
Valbiotis (EU:ALVAL)
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Valbiotis (EU:ALVAL)
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