First development milestone payment of CHF 3
million from Nestlé Health Science
- The first subject, with fasting hyperglycemia, underwent the
initial protocol medical visit prior to randomization at one of the
study's clinical investigation centers.
- The international REVERSE-IT 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 and it will be led in more than 30
centers in France and abroad.
- This First Visit of the First Patient triggers a first
milestone payment of CHF 3 million from Nestlé Health Science,
thereby strengthening VALBIOTIS’ cash position.
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 the First Patient First Visit in the international Phase
II/III REVERSE-IT clinical study designed to assess TOTUM-63 for
the reduction of Type 2 Diabetes metabolic risk factors.
Murielle CAZAUBIEL, member of the Management Board and Director
of Development and Medical Affairs at VALBIOTIS, comments: "The
first visit of this first subject, a few days after obtaining both
ANSM1 approval and the favorable decision from the
CPP2, marks the concrete launch of the REVERSE-IT study, the
results of which are expected in mid-2022. We are right on schedule
and are delighted to be able to enter the operational phase of this
major study so quickly. We also welcome the enthusiasm and
commitment of all the partner investigation centers."
Dr Hans-Juergen WOERLE, Chief Scientific and Medical Officer at
Nestlé Health Science, states: "The first visit of the first
subject in the Phase II/III study is a great step forward for
TOTUM-63 and encouraging news for patients with prediabetes or
untreated early stage Type 2 diabetes. With the 600 patients in
this global clinical study, the objective is to demonstrate
efficacy and safety of a new plant-based extract.“
The pivotal, randomized, double-blind, placebo-controlled
REVERSE-IT study will include 600 patients with fasting
hyperglycemia ranging from prediabetes to untreated early stage
Type 2 Diabetes. The study should confirm the efficacy of TOTUM-63
- at a dose of 5g/day for 6 months - in addressing the metabolic
risk factors for developing Type 2 Diabetes, compared to placebo.
The protocol will assess the effect of TOTUM-63 on fasting blood
glucose, the primary endpoint of the study, as well as on two-hour
blood glucose and anthropometric parameters (body weight, waist
circumference and body fat mass), all well-known risk factors for
Type 2 diabetes.
REVERSE-IT is being conducted in more than 30 centers in France
and internationally.
As a result of this achievement, VALBIOTIS will receive the
first milestone payment of CHF 3 million from Nestlé Health
Science. The global strategic partnership with Nestlé Health
Science, concluded in February 2020, includes an upfront payment of
CHF 5 million, already received by Valbiotis, development &
sales milestone payments up to a maximum CHF 66 million and tiered
royalties on net sales. The agreement also includes the supply of
TOTUM-63 by VALBIOTIS to Nestlé Health Science, representing an
additional source of revenue.
ABOUT THE REVERSE-IT STUDY
The international Phase II/III REVERSE-IT study is the final
step in the clinical development of TOTUM-63, an innovative
plant-derived active substance designed to reduce the risk factors
for type 2 diabetes.
This randomized, double-blind, placebo-controlled study will
involve 600 patients with impaired glucose metabolism ranging from
prediabetes to untreated type 2 diabetes (early stage). The
protocol calls for oral intake of TOTUM-63 at a dose of 5 g/day for
6 months, versus placebo.
The REVERSE-IT study is expected to confirm the efficacy of
TOTUM-63 on the major risk factors for type 2 diabetes: fasting
blood glucose elevation, the primary endpoint of the study,
two-hour blood glucose and anthropometric parameters (body weight,
waist circumference and body fat).
REVERSE-IT is being conducted following the positive results of
the TOTUM-63 Phase II clinical study, published in July and
September 2019. It was co-designed with the medical and regulatory
teams of Nestlé Health Science, as part of the global strategic
partnership for the development and marketing of TOTUM-63, signed
by the two companies in February 2020. It will be conducted in more
than 30 clinical investigation centers in France and abroad.
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.
1 ANSM: French National Agency for the Safety of Medicines and
Health Products 2 CPP: French Research Ethics Committee
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version on businesswire.com: https://www.businesswire.com/news/home/20200715005644/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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