DJ Valbiotis announces its roadmap and strategic priorities on the eve of key milestones for its portfolio of innovative active substances
VALBIOTIS SA
Valbiotis announces its roadmap and strategic priorities on the eve of key milestones for its portfolio of innovative
active substances
12-Jul-2023 / 17:40 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
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Press release
Valbiotis announces its roadmap and strategic priorities
on the eve of key milestones for its portfolio
of innovative active substances
-- Following the announcement of the major success of the Phase II/III REVERSE-IT study on its primary
endpoint (TOTUM.63, prediabetes / type 2 diabetes), the full results of the Phase II/III REVERSE-IT study will be
released in September;
-- Clinical development operations are progressing on the portfolio's other active substances, TOTUM.854
(raised blood pressure), TOTUM.070 (hypercholesterolemia) and TOTUM.448 (hepatic steatosis);
-- With regard to the launch of TOTUM.070, direct commercial launch in France is confirmed for the first
half of 2024 and discussions are ongoing with a view to signing one or more international commercial partnerships;
-- In preparation for the first market launches, Valbiotis is continuing to structure its industrial and
commercial development.
La Rochelle, July 12, 2021 (17:40 CEST) - Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a commercially oriented
Research and Development company committed to scientific innovation for preventing and combating metabolic and
cardiovascular diseases, today sets out its roadmap for the coming months, which promise to be rich in clinical,
industrial and commercial developments.
The next key milestone for the Company will be the communication of detailed results from the Phase II/III REVERSE-IT
study on TOTUM.63, which will complement the announcement of the study's first success on its primary endpoint last May
(press release, May 22, 2023). As a reminder, this international, multicenter, randomized, placebo-controlled study was
carried out in a population of 636 volunteers with prediabetes and early-stage, untreated type 2 diabetes. The study
met its primary endpoint with high statistical significance: TOTUM.63 reduced fasting blood glucose (a risk factor for
type 2 diabetes) versus placebo after 24 weeks at a daily dose of 5 g taken 3 times a day; the fasting blood glucose
reduction endpoint was also met with high significance at a similar dose but taken 2 times a day, the optimal dosing
schedule. Valbiotis looks forward to the communication of full results of the REVERSE-IT study with great confidence,
at the same time as the commercial phase of the global strategic partnership with Nestlé Health Science gets underway.
The next scientific steps will include the submission of clinical data from the REVERSE-IT study to international
congresses and publication in international peer-reviewed journals. In addition, the results of the mode-of-action
clinical study on TOTUM.63, conducted on 19 volunteers by INAF in Quebec City, are expected in the second half of 2023.
Strengthened by the scientific validation obtained for TOTUM.63, Valbiotis will pursue the clinical development of the
other three active substances in its portfolio:
-- The great success of the Phase II HEART study on TOTUM.070 (hypercholesterolemia) demonstrated the
efficacy of this active substance after three months on blood levels of LDL cholesterol and triglycerides
(respectively -13.7% and -14.3% per protocol) and after 6 months (-14.3% and -14.4% respectively), with an
improvement in the overall lipid profile, in a population with mild to moderate hypercholesterolemia. The Company
is preparing a final Phase II/III clinical stage, which will provide the clinical data required to file a health
claim. This clinical phase will be conducted in parallel with, and independently of, the commercial launch of
TOTUM.070 in France.
-- Concerning TOTUM.854 (raised blood pressure), recruitment for the Phase II/III INSIGHT study is ongoing
and should be completed in the fourth quarter of 2023. Recruitment for the second Phase II/III INSIGHT 2 study (100
people recruited to date out of a total of 400) will be completed at a later date.
-- Finally, the definitive clinical strategy for TOTUM.448 (hepatic steatosis) and the academic partnerships
involved will be unveiled in the coming months.
Structuring for industrial and commercial growth
In parallel with these R&D efforts, the Company is continuing to structure itself, with a dual objective. Firstly, to
prepare for the direct marketing of TOTUM.070, TOTUM.854 and TOTUM.448 in France. Secondly, to support the global
agreement with Nestlé Health Science for TOTUM.63, as well as future international partnerships for the other three
products. On the industrial processes front, Valbiotis is continuing to set up the supply chain, from sourcing plant
raw materials through to marketing. Regarding marketing in France (in pharmacies and online), the IT infrastructure and
e-commerce platform are being developed, and sales and marketing activities are being organized. The sales timetable in
France has thus been confirmed, with TOTUM.070 due for launch in the first half of 2024.
Lastly, as regards TOTUM.070, Business Development activities are continuing in line with the plan and strategy
announced, with the help of AEC Partners, Valbiotis' long-standing Business Development partner and the driving force
behind the agreement with Nestlé Health Science. Discussions already initiated are ongoing with several global and
regional players in the nutrition and health sectors. The ambition remains to sign one or more licensing and/or
distribution agreements worldwide (excluding France).
Sébastien PELTIER, Co-Founder and Chairman of the Valbiotis Executive Committee, comments: "The announcement of our
success on the primary endpoint marks the first major milestone of our R&D strategy, which has always aimed to obtain a
high level of clinical evidence for our plant-based active substances. The forthcoming communication of the full
results will mark a decisive step: these results will establish the final clinical value of TOTUM.63 against
prediabetes and the early stages of type 2 diabetes. At the same time, we are now structuring the Company with a view
to its industrial and commercial ramp-up, with the next milestones shaping up to be particularly exciting: market
launch of TOTUM.63, signature of a strategic agreement for TOTUM.070 and commercial launch of TOTUM.070 in France.
Valbiotis remains on course to bring its four portfolio products to market, to meet the immediate needs of the millions
of patients concerned by metabolic and cardiovascular risks, and to satisfy the high expectations of healthcare
professionals in terms of prevention."
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 or distribution agreements with global and
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 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
Contacts
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 / Actifin
Stéphane Ruiz
Associate Director
+33 1 56 88 11 14
sruiz@actifin.fr
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.
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Regulatory filing PDF file
File: Press Release Valbiotis Roadmap S2 2023
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Language: English
Company: VALBIOTIS SA
12F, Rue Paul Vatine
17180 Périgny
France
Phone: 0546286258
E-mail: contact@valbiotis.com
Internet: www.valbiotis.com
ISIN: FR0013254851
Euronext Ticker: ALVAL
AMF Category: Inside information / Other releases
EQS News ID: 1678683
End of Announcement EQS News Service
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1678683 12-Jul-2023 CET/CEST
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July 12, 2023 11:40 ET (15:40 GMT)
