Valbiotis Announces the Last Visit of the Last Patient in the Phase II/III REVERSE-IT Study on TOTUM•63, in Partnership with Nestlé Health Science
March 13 2023 - 12:40PM
Business Wire
- The last patient included in the study has completed the final
protocol follow-up visit.
- The first results of the study will be released before the end
of the first half of 2023, after the database is frozen and the
statistical analysis work is completed.
- This international, multicenter Phase II/III 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).
- Its primary objective is to reduce fasting blood glucose levels
after 24 weeks of supplementation with a daily dose of 5 g of
TOTUM•63, in 3 intakes, compared with placebo.
- The REVERSE-IT study was co-designed by Nestlé Health Science
and Valbiotis as part of the overall strategic partnership between
the two companies on TOTUM•63; as such, the results of the study
are associated with milestone payments from Nestlé Health
Science.
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible)
(Paris:ALVAL), a commercially oriented Research and Development
company, committed to scientific innovation for preventing and
combating metabolic and cardiovascular diseases, announces the last
visit of the last patient enrolled in the Phase II/III REVERSE-IT
study on the active substance TOTUM•63. This international,
multi-center, randomized, placebo-controlled study on 600 untreated
prediabetic and type 2 diabetic patients (early stage) is designed
to confirm the efficacy of TOTUM•63 on impaired glucose metabolism.
The first results will be available and communicated before the end
of the first half of 2023, in accordance with the schedule
announced on September 15, 2022.
TOTUM•63 is a unique and patented combination of 5 plant
extracts that targets the pathophysiological mechanisms of type 2
diabetes. It has been developed to address a large unmet need: to
act on metabolic impairments in the early stages of type 2
diabetes, in particular prediabetes. Prediabetes currently affects
nearly 900 million people worldwide, including 128 million in the
United States and the five main European1 countries, for whom no
non-drug health product yet has solid proof of efficacy.
Nestlé Health Science has the exclusive and global commercial
rights to use TOTUM•63 in the prediabetes and type 2 diabetes
market.
Murielle CAZAUBIEL, Director of Medical, Regulatory and
Industrial Affairs, member of the Valbiotis Executive Committee,
comments: "The development of TOTUM•63, our first innovative active
substance, is nearing completion. The conclusion of the REVERSE-IT
study is an unprecedented achievement for Valbiotis: with 600
patients enrolled in more than 50 centers worldwide, REVERSE-IT is
one of the largest and most ambitious studies conducted globally
with non-drug approaches in early dysglycemia, from prediabetes to
early type 2 diabetes. We would like to pay tribute to the
long-term work carried out by all the teams involved, without whom
this challenge could not have been met. We also thank the Nestlé
Health Science teams for their guidance and support as part of our
strategic partnership on TOTUM•63. The demanding work of analyzing
the database will now begin, with the hope that it will confirm the
potential of TOTUM•63 for people affected by the risk of diabetes
and its early stages and pave the way for the commercialization of
this breakthrough active substance."
Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer
at Nestlé Health Science, adds: "We co-designed the REVERSE-IT
study with Valbiotis to provide a large clinical dataset on
TOTUM•63 for the benefit of people with early dysglycemia. An
increasing number of people around the world are at risk of type 2
diabetes. We welcome the completion of this highly ambitious study
and look forward to the initial results for the management of this
early deterioration in glucose metabolism."
The Phase II/III REVERSE-IT randomized, double-blind,
placebo-controlled study includes 600 people with impaired glucose
metabolism, ranging from prediabetes to untreated type 2 diabetes
(early stage). Its primary objective will be to confirm the
reduction of fasting blood glucose levels by TOTUM•63 taken three
times daily for a total daily dose of 5 g over 24 weeks. The
protocol will also evaluate the effect of the same daily dose of
TOTUM•63 on fasting blood glucose levels but taken twice daily.
Finally, REVERSE-IT will evaluate the effects of TOTUM•63 on other
metabolic parameters of interest.
Following the collection and monitoring of data from the last
follow-up medical visits planned in the protocol, the clinical
database will be frozen for statistical analysis. At the end of
this process in accordance with Good Clinical Practices, Valbiotis
confirms that the first results of the REVERSE-IT study will be
available and communicated before the end of the first half of
2023, as announced in the schedule published on September 15, 2022
(September 15, 2022, press release).
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 patients 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,
Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia,
Chili, India, South Korea and national phases are still underway in
Brazil, Argentina, Canada, Thailand, Qatar, 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 worldwide 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 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. 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 May 19,
2022 and completed by an amendment on November 8, 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.
1AEC Partners data on Valbiotis' key markets, 2019
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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
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