Valbiotis Announces Completion of Recruitment for the Phase II/III REVERSE-IT Clinical Study With TOTUM•63 Against Prediabetes, in Partnership With Nestlé Health Science
28 Juli 2022 - 07:35AM
Business Wire
- The last volunteer was enrolled in the REVERSE-IT study;
recruitment of the 600 participants in this international,
multicenter, randomized, placebo-controlled clinical study is
complete.
- This Phase II/III study is evaluating the efficacy of TOTUM•63,
a plant-based active substance, in a population with impaired
glucose metabolism, from prediabetes to untreated type 2 diabetes
(early stage).
- The primary objective of the study will be the reduction of
fasting blood glucose levels after 24 weeks of TOTUM•63
supplementation compared to placebo; the results will be announced
at the end of the study.
- This Phase II/III clinical study was co-designed by Nestlé
Health Science and Valbiotis, as part of the global strategic
partnership between the two companies on TOTUM•63.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible)
(Paris:ALVAL), a Research and Development company committed to
scientific innovation for preventing and combating metabolic and
cardiovascular diseases, announces that it has completed the
recruitment of 600 volunteers for the international multicenter
Phase II/III REVERSE-IT clinical study on TOTUM•63.
This randomized, placebo-controlled study evaluates the efficacy
of TOTUM•63, a plant-based active substance, in a population with
impaired glucose metabolism, from prediabetes to untreated type 2
diabetes (early stage). The primary objective will be the reduction
of fasting blood glucose levels after 24 weeks of TOTUM•63
supplementation compared to placebo. The results will be
communicated at the end of the study.
The Phase II/III REVERSE-IT study was co-designed by the
Valbiotis and Nestlé Health Science medical and regulatory teams to
demonstrate the efficacy of TOTUM•63 against prediabetes and
untreated type 2 diabetes (early stage), as part of the global
strategic partnership between the two companies. REVERSE-IT should
confirm the positive results of the Phase II clinical study already
obtained in a similar population with TOTUM•63.
Murielle CAZAUBIEL, Director of Medical, Regulatory and
Industrial Affairs and member of the Valbiotis Board of Directors,
commented: “We have reached a very important milestone in the
development of TOTUM•63 with the completion of enrollment in the
Phase II/III REVERSE-IT study. With 600 volunteers enrolled in more
than 50 centers worldwide, REVERSE-IT is among the most ambitious
studies of early dysglycemia, from prediabetes to early-stage type
2 diabetes, using non-drug approaches. We would like to thank all
the teams involved in this project, as well as our partner Nestlé
Health Science. With a highly demanding design, REVERSE-IT was
developed to provide comprehensive and robust efficacy data on
these populations in preparation for the TOTUM•63 market
launch.”
The randomized, double-blind, placebo-controlled Phase II/III
REVERSE-IT study includes 600 people with impaired glucose
metabolism, from prediabetes to untreated type 2 diabetes (early
stage). It should confirm the efficacy of TOTUM•63 at a dose of 5
g/day (3 daily intakes) for 24 weeks on blood glucose abnormalities
and other metabolic risk factors for type 2 diabetes, compared to a
placebo. The protocol will evaluate the effect of TOTUM•63 on
fasting blood glucose, the primary endpoint of the study, as well
as on a number of secondary endpoints of interest, including
two-hour blood glucose and anthropometric parameters (body weight,
waist circumference and body fat mass).
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 has already been shown to
be safe and effective in healthy volunteers in a Phase I/II
clinical study. Results from a randomized, placebo-controlled,
international Phase II study showed that when compared to the
placebo, TOTUM•63 reduced fasting blood glucose and 2-hour blood
glucose levels, two risk factors for type 2 diabetes. In these
subjects, who were also abdominally obese, TOTUM•63 also
significantly reduced body weight and waist circumference. 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 and national phases are still underway in a
dozen other countries including Brazil and Australia. 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 worldwide scale, possibly before obtaining a
health claim depending on the area. They will also fund the final
stages of development of TOTUM•63.
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 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 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220727005561/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 Director of Operations
+33 6 80 28 47 70 damien.maillard@prpa.fr
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