Valbiotis announces the major success of the INSIGHT clinical study on TOTUM•854

Valbiotis announces the major success of the
INSIGHT clinical study on TOTUM•854: Demonstrated efficacy
in reducing systolic blood pressure (SBP)
in individuals with untreated mild hypertension

• The study's primary endpoint was met, with a significant difference vs. placebo in the reduction of systolic blood pressure (SBP) in individuals with mild, untreated hypertension (p<0.05).

• The Totum•854 group showed a highly significant decrease in SBP of -9 mmHg after 3 months of supplementation (129 ± 9 mmHg vs. 138 ± 6 mmHg at Baseline).

• The study also demonstrated Totum•854's excellent safety and tolerability, as well as a compliance rate of over 98%.

• TOTUM•854 is now the 3rd Valbiotis product to obtain unequivocal clinical proof of efficacy after Lipidrive® (formerly known as TOTUM•070) for hypercholesterolemia and TOTUM•63 for pre-diabetes and the early stages of type 2 diabetes. This validates Valbiotis' scientific approach based on innovative combinations of plant-based active ingredients.

La Rochelle, 15 octobre 2024 (17H40 CEST) – Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible), a Research and Development company with a commercial arm, dedicated to scientific innovation in preventing and combating metabolic and cardiovascular diseases, announces the major success of the INSIGHT study on TOTUM•854. Carried out on four hundred and ten participants with high normal blood pressure or untreated stage 1 hypertension, this international, multicenter, randomized, placebo-controlled study validates the efficacy of TOTUM•854 at a dose of 3.7g per day on the primary endpoint of lowering systolic blood pressure after 3 months of supplementation.

Once all the analyses have been completed, the full results of the INSIGHT study will be submitted for presentation at international congresses and in international peer-reviewed journals. The Company will subsequently announce its launch plan for TOTUM•854.

Jean-Marie Bard, Professor Emeritus of Biochemistry, Hospital Pharmacist, Science Officer for the INSIGHT Study and Chairman of the Scientific Committee of the French Nutrition Society, explains: “Hypertension is a major cause of premature death worldwide, affecting around 1.13 billion people. The primary objective of the INSIGHT clinical study was to evaluate the efficacy of TOTUM•854 in reducing systolic blood pressure (SBP) in individuals with high normal blood pressure (SBP 130-139 mmHg and/or DBP 85-89 mmHg) or stage 1 hypertension (SBP 140-159 mmHg and/or DBP 90-99 mmHg). Throughout a 3-month supplementation period, participants took 3.7g per day of T•854 or placebo. The INSIGHT clinical study has for the first time demonstrated the efficacy of TOTUM•854 in reducing SBP in individuals with mild untreated hypertension. The unambiguous results of TOTUM•854 in this large-scale multicenter study, with over 400 patients included, definitively validate its clinical efficacy. TOTUM•854 is therefore a highly promising non-drug solution for reducing SBP and preventing the risk of associated cardiovascular diseases.”

Sébastien Peltier, Co-Founder and Chairman of the Valbiotis Executive Committee: “We are proud to announce these positive clinical results. They mark a decisive step forward in our fight to prevent metabolic and cardiovascular diseases. This study is fully in line with our goal to bring innovative and effective solutions to millions of people across France. It is the latest study born out of a rigorous scientific approach that, for over 10 years, has been an integral part of our work towards fulfilling our mission, that of helping to improve quality of life for everyone.”

About Valbiotis

Valbiotis is a French scientific research laboratory specializing in the development and marketing of dietary supplements that support daily health and prevent and combat metabolic disorders that cause cardiovascular disease.

Valbiotis has adopted an innovative approach aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the impact of metabolic disorders and minimize cardiovascular risk factors. This approach relies on a multi-target strategy made possible with the use of marine and terrestrial, plant-based resources.

Created at the beginning of 2014 in La Rochelle, France, Valbiotis has forged numerous partnerships with leading academic centers. The Company has three sites in France – Périgny, La Rochelle and Riom – and a subsidiary in Quebec (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 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.

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