Valbiotis Announces Approval to Launch the Two Phase II/III INSIGHT and INSIGHT 2 Clinical Studies, the Last Step in the Development of TOTUM•854 For the Reduction of Blood Pressure
17 Février 2022 - 7:35AM
Business Wire
- These authorizations enable the simultaneous launch of
recruitment for these international studies, which should be
completed in the first half of 2023.
- The INSIGHT and INSIGHT 2 randomized, placebo-controlled
studies are designed to include a total of 800 volunteers with mild
to moderate elevated blood pressure, with 400 volunteers in each
study.
- They will test the effect of a daily dose of 3.7 g and 2.6 g
respectively of TOTUM•854, for 3 months, with the primary endpoint
being the reduction of systolic blood pressure.
- The innovative active substance TOTUM•854 is entering the final
stage of development for the management of the early stages of
hypertension, one of the world's most prevalent cardiovascular risk
factors.
Regulatory News:
Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA / SME
eligible), a Research and Development company committed to
scientific innovation for preventing and combating metabolic
diseases, announces that it has received approval to launch the two
international multicenter Phase II/III INSIGHT and INSIGHT 2
clinical studies on TOTUM•854, for the reduction of blood pressure.
These two trials will include 800 volunteers with mild to moderate
elevated blood pressure, a risk factor for cardiovascular diseases,
with 400 volunteers in each study. The authorizations received
enable the launch of clinical recruitment, scheduled to be
completed in the first half of 2023.
Murielle CAZAUBIEL, member of the Board of Directors, Director
of Medical, Regulatory and Industrial Affairs at Valbiotis,
commented: "The approvals received for the INSIGHT and INSIGHT 2
clinical studies are an important milestone for the development of
TOTUM•854, which is now entering its final stage. They allow us to
begin an ambitious recruitment phase - 800 volunteers in total -
for these international Phase II/III studies. In addition, from a
medical point of view, the validation of the protocols by the
health authorities confirms the innovative positioning of TOTUM•854
in the field of hypertension. The INSIGHT and INSIGHT 2 trials,
through their methodology, should now provide the clinical evidence
that will support the promise of this active substance for the
management of the early stages of arterial hypertension".
TOTUM•854 is the second plant-based active substance in the
Valbiotis product portfolio to enter Phase II/III clinical studies
and will address the lack of non-drug treatment for hypertension,
complementing therapeutic solutions and supported by strong
scientific evidence.
The results of the two INSIGHT and INSIGHT 2 clinical studies
are essential for a health claim application for the reduction of
blood pressure, a risk factor for cardiovascular diseases, in
Europe and the United States. They will comply with the protocols
validated by the competent authorities:
- The INSIGHT Phase II/III international, multicenter,
randomized, placebo-controlled clinical study will be conducted on
a population of 400 volunteers with mild to moderate elevated blood
pressure (systolic blood pressure between 130 mmHg and 159 mmHg and
diastolic blood pressure < 100 mmHg). It will include two
groups: a TOTUM•854 group with a dose of 3.7 g/day and a placebo
group. The primary endpoint will be a reduction in systolic blood
pressure, after 3 months of supplementation, between the TOTUM•854
group and the placebo group. In addition, 24-hour ambulatory blood
pressure measurement will be performed and will be one of the
secondary endpoints of the study.
- The INSIGHT 2 clinical study, also international, multicenter,
randomized and placebo-controlled, will be carried out on 400 other
subjects with the same inclusion criteria. There will be two
groups: a TOTUM•854 group receiving a reduced dose (2.6 g/day) and
a placebo group. The primary endpoint will be a reduction in
systolic blood pressure, after 3 months of supplementation, between
the TOTUM•854 group and the placebo group.
In addition to these clinical efficacy studies, the development
plan for TOTUM•854 includes a bioavailability and mode of action
study in 10 volunteers to characterize TOTUM•854 metabolites and
identify their effects on human cell lines. The results are
expected by the end of 2022.
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 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 Mnemonic code: 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 July
27, 2021 (application number R 21-039). 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/20220216005832/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
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