Business Wire

Valbiotis Reveals Positive TOTUM•854 Preclinical Results in the Prevention of Hypertension at the Annual ESH-ISH Joint Meeting


Regulatory News:

This press release features multimedia. View the full release here:

To view this piece of content from, please give your consent at the top of this page.

Figure 1: Effect of TOTUM•854 supplementation on systolic (SBP) and diastolic (DBP) blood pressure after 3 weeks, in an induced hypertension model (L-NAME model). After 3 weeks, L-NAME induced a 24 mmHg-raise in SBP and a 19 mmHg- raise in DPB (grey bars). Supplementation with TOTUM•854 (blue bars) significantly reduced SBP by 16 mmHg (p<0.01) and DBP by 15 mmHg (p<0.05). (Graphic: Business Wire)

VALBIOTIS (FR0013254851 – ALVAL, PEA-SME eligible) (Paris:ALVAL), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the presentation of positive preclinical results of TOTUM•854 in hypertension at the joint meeting of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH) held from April 11 to 14, 2021, in virtual format.

This research, conducted on two different in vivo models, shows that TOTUM•854 prevents hypertension.
Based on this positive data, Valbiotis is stepping up its development of TOTUM•854 and will launch three clinical studies at the end of this year, including a Phase II/III clinical study for reduction of hypertension, a risk factor for cardiovascular disease.
TOTUM•854 could be commercialized at the end of this study, up to 3 years ahead of schedule, in partnership with a major healthcare player.

Pascal SIRVENT, Member of the Board and Head of Discovery, Preclinical and Translational Research at Valbiotis, said: “We are proud of this first selection at a major international congress in the cardiovascular field, for which Valbiotis has partnered with the University of Avignon. The TOTUM•854 data collected from two different models of hypertension is remarkable, it validates our hypotheses and our approach to this condition. This very strong proof-of-concept for prevention of hypertension points to ambitious clinical development for TOTUM•854.”

The work presented at the ESH-ISH Joint Meeting was conducted on a model of hypertension induced by L-NAME (a NO synthase inhibitor). In this classic model of hypertension, predictive of human physiology, TOTUM•854 prevented the onset of hypertension compared with the control group. Additional data, obtained from a polygenic model of hypertension (SHR, spontaneously hypertensive rats), also shows a positive effect of TOTUM•854 that delays the onset of hypertension. In addition, a significant acute effect was observed following a single dose of TOTUM•854 on the same SHR model.

Table 1: Effect of a single oral dose of TOTUM•854 in a polygenic model of hypertension (SHR model) on systolic (SBP) and diastolic (DBP) blood pressure, during 24 hours. Starting the experiment (« baseline »), SBP (164 mmHg) and DBP (115 mmHg) were typical of an installed hypertension. Oral intake of a TOTUM•854 dose led to blood pressure reduction, resulting in a decrease of both SBP and DBP Areas Under the Curve (AUC), over a 24h-record compared to the control group.


(mmHg; mean ± SEM)

Change in area under the curve over
the 24 hours following one dose of TOTUM•854
(mmHg x h, mean ± SEM)


164.4 ± 4.7

-108.0 ± 87.8


115.9 ± 3.6

-84.4 ± 69.3

These results stem in particular from a program carried out under a partnership between Valbiotis and the experimental unit of the Cardiovascular Pharm-Ecology Lab (LaPEC) of the University of Avignon, directed by Cyril REBOUL, PhD, expert in cardiovascular pharmacology.

Cyril REBOUL, PhD, head of the experimental unit of the Cardiovascular Pharm-Ecology Lab (LaPEC) of the University of Avignon, said: “Through our work, we have shown a preventive effect of TOTUM•854 on the development of hypertension in a recognized preclinical model using the L-NAME inhibitor. Undeniably, these results constitute quite an achievement at this stage of TOTUM•854’s development. We are very pleased to have been able to contribute our expertise as part of this fruitful partnership with Valbiotis.”

Acceleration of the development for commercialization now scheduled for 2023

Based on these results, Valbiotis has revised its clinical development program for TOTUM•854 with the launch of a Phase II/III study, the last step before a health claim application in Europe and the United States for reduction of blood pressure, a risk factor for cardiovascular disease. This international, multicenter, randomized, placebo-controlled study will be conducted in a population of 600 volunteers with mild to moderately elevated blood pressure. The study will involve three groups: a TOTUM•854 group at a dose of 3.75 g/day, a TOTUM•854 group at a dose of 2.5 g/day and a placebo group. Its primary endpoint will be the reduction of systolic blood pressure in the TOTUM•854 group (3.75 g/day) after 6 months of supplementation versus the placebo group. It will also evaluate the effect of a reduced dose of TOTUM•854 (2.5 g/day) on blood pressure. In addition, 24-hour ambulatory blood pressure measurements will be taken as a secondary endpoint of the study. The protocol is expected to be filed with the authorities in the fourth quarter of 2021, with results anticipated in the second half of 2023.
A second international, multicenter, randomized, placebo-controlled clinical study will be conducted in parallel at a dose of 3.75 g/day of TOTUM•854. This strategy will allow Valbiotis to prepare a complete health claim application.
Finally, Valbiotis will conduct a third clinical study to measure the bioavailability of TOTUM•854, characterize its metabolites and explore their mode of action.

Murielle CAZAUBIEL, Member of the Board, Head of Development and Medical Affairs at Valbiotis, said: “These preclinical results raise great hopes for the clinical development of TOTUM•854 in the prevention of hypertension. That’s why we are accelerating our strategy for this active substance. Hypertension is considered the foremost chronic disease in the world by the World Health Organization. It’s a serious risk factor for cardiovascular disease, in particular strokes. TOTUM•854 could quickly become an extremely interesting non-drug alternative for people at risk, whether or not they are already taking treatment. This plant-derived active substance would ultimately be developed in the form of capsules or powder for dilution.”

The new strategic development plan will leverage the potential of TOTUM•854 in preventing hypertension, with the aim of bringing it to market as soon as the Phase II/III study ends, in other words by 2023.

Market data on mild to moderate hypertension: conquering an addressable market of over one billion euros

In 2020, AEC Partners conducted a mild to moderate hypertension market study in the United States and 5 main European countries (Germany, Spain, France, Italy and the United Kingdom).
It highlights the size of this market in these regions, which alone represents 124 million people with moderately elevated blood pressure.

Sébastien PELTIER, CEO and Chairman of the Board, said: “In the US and 5 main European countries (Germany, Spain, France, Italy and the United Kingdom), our target represents 124 million people with mild to moderately high blood pressure. TOTUM•854 will give us access to a huge market worth over €1.15 billion. We are now embarking on a new cycle with the development of TOTUM•854 for prevention of hypertension. By accelerating our strategy, we will gain 3 years on our development plan, with a possible market launch on completion of the Phase II/III study. I am confident that we will achieve growth and create value for our shareholders over the long term, turning our innovations into products that can transform the lives of millions by addressing as yet unmet medical needs.”

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, based on a multi-target approach enabled by the use of plant-based ingredients.
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).
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:

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 the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and uncertainties, including those described in the VALBIOTIS registration document, filed with the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018). This document is available on the Company's website (
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.

To view this piece of content from, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
+33 5 46 28 62 58

Financial communication / Actifin
Stéphane RUIZ
+33 1 56 88 11 14

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Incyte and MorphoSys Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-Line Treatment for Diffuse Large B-Cell Lymphoma11.5.2021 22:01:00 CEST | Press release

Incyte (NASDAQ:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation. This press release features multimedia. View the full release here: “While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current outcomes for high-risk patients are poor,” said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. “We believe we may be able to make a difference for those DLBCL patien

Lattice Automate Solution Stack Accelerates Development of Industrial Automation Systems11.5.2021 20:00:00 CEST | Press release

Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today extended its portfolio of comprehensive low power FPGA-based solution stacks with the introduction of Lattice Automate™. The stack includes software tools, industrial IP cores, modular hardware development boards, and software-programmable reference designs and demos that simplify and accelerate implementation of applications like robotics, scalable multi-channel motor control with predictive maintenance, and real-time industrial networking. Intelligent industrial systems made possible by Automate will play a vital role in automating future smart factories, warehouses, and commercial buildings. This press release features multimedia. View the full release here: Introducing the Lattice Automate solution stack for the accelerated development of industrial automation applications. (Graphic: Business Wire) Technology trends like the IoT and Ed

Esri and IBM Team Up to Take on Climate Change with Call for Code11.5.2021 19:23:00 CEST | Press release

Esri, the global leader in location intelligence, today announced it is joining the fourth annual Call for Code Global Challenge. Created by David Clark Cause and launched in partnership with IBM, United Nations Human Rights, and the Linux Foundation, Call for Code is designed to make an immediate and lasting global impact on humanitarian issues, using open-source-powered technology. In this year’s competition, software developers and innovators around the world will take on climate change with open-source software, including Red Hat OpenShift, IBM Cloud, IBM Watson, IBM Blockchain, and data from The Weather Company. Since Call for Code was launched in 2018, more than 400,000 developers and problem solvers across 179 nations have participated, creating more than 15,000 applications. This year’s competition focuses on three sub-themes related to combating climate change: water availability and consumption, food production and delivery, and economic production and consumption. The winnin

Experian Announces New Commitment to a Flexible Working Culture11.5.2021 18:26:00 CEST | Press release

Experian, the global information services company, has today announced a new global approach to work. The aim is to take the learnings from the experience of Covid-19 lockdown and create a working environment which suits everyone’s situation. Experian is committing to promote more individual choice by creating a new hybrid model, where employees will be encouraged to ‘work your way’. Through the lockdown, Experian moved its global operations to remote working with very limited disruption. Most employees will be offered increased flexibility, with the majority moving to a hybrid model, some working fully remotely, and some in the office. Experian – which operates in 45 countries around the world – believes this will continue to boost productivity and improve the work / life balance options for its 17,800 global employee base. What the Covid-19 crisis has reminded us, beyond everything else, is that we are all individuals living very different lives. That’s prompted Experian to go down t

SentinelOne is the Only Vendor to Score Highest Across All Three Gartner Critical Capabilities Use Cases11.5.2021 17:40:00 CEST | Press release

SentinelOne, the autonomous cybersecurity platform company, today announced that Gartner has positioned SentinelOne with the highest scores in all three use cases; Type A, B, & C in Gartner’s 2021 Critical Capabilities for Endpoint Protection Platforms report1. Out of the 19 vendors included in the report, SentinelOne is the only vendor that received the highest score across all three Critical Capabilities use cases: Customer use case Type A is focused on “lean forward” organizations that adopt new technologies very early in the adoption cycle. Customer use case Type B is focused on “overall value” by weighing the risks of the early use of new technology against the benefits. Customer use case Type C represents organizations that typically view technology as an expense or operational necessity and use it as a means to reduce costs. “We believe receiving the highest product score across all three customer use cases in the 2021 Critical Capabilities for Endpoint Protection Platforms vali

1E Challenges DEM Market to Deliver More, Launching New Unified eXperience Management Category11.5.2021 16:35:00 CEST | Press release

1E, innovators in endpoint management, today announced Unified eXperience Management (UXM), a new category that seeks to address the siloed approach inherent in tools in the Digital Experience Monitoring (DEM) space. This press release features multimedia. View the full release here: 1E Tachyon Platform: Unified eXperience Management to improve the Digital Experience of all employees (Graphic: Business Wire) Due to the relative immaturity of the Digital Experience Management category, most tooling is focused on identifying and reporting on the scale of the problem, scoring, and issue identification. These tools create analytics silos that give insight, but are uncoupled from the automation technology that can actually improve end-user experience at an enterprise scale. Meanwhile, employees are becoming increasingly more frustrated, with 56% feeling dissatisfied with their IT experience. Organizations looking to improve the digit

Biorasi Receives ISO 9001:2015 Certification for Quality Management11.5.2021 16:30:00 CEST | Press release

Biorasi, a leading global full-service contract research organization (CRO), is proud to announce the achievement of ISO 9001:2015 certification. By earning this ISO accreditation, Biorasi has demonstrated dedication to the practice of quality assurance within the clinical trials industry and commitment to quality excellence for individual clinical studies. “ISO 9001:2015 certification is a big deal for Biorasi,” said Chris O’Brien, CEO at Biorasi. “It is a powerful, independent validation of the quality of our processes. It sends a message to potential sponsors across the globe that Biorasi cares deeply about quality. It tells them they can trust us.” Biorasi was presented with their ISO 9001:2015 certification on May 5, 2021, joining the ranks of other quality-focused organizations, including our preferred vendor, IBM Watson Health. “Our Quality Policy is driven by the fundamental understanding that patients and their families are affected by the decisions we make,” said Todd Brill,