Business Wire

Valbiotis Announces That It Has Submitted to the Competent Authorities the Three Clinical Protocols for TOTUM•854 Indicated in the Reduction of Blood Pressure and Presents Its Comprehensive Clinical Development Plan

Share

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) (Paris:AVAL), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces that it has submitted the three clinical protocols for TOTUM•854, indicated in the reduction of blood pressure, to the competent authorities and presents its comprehensive clinical development plan, as announced at the annual meeting of the European Society of Hypertension and of the International Society of Hypertension in April 2021 (Press release dated April 12, 2021).

TOTUM•854 is the second plant-based active substance from the Valbiotis product portfolio to enter Phase II/III clinical trials and will address an unmet medical demand for non-drug prevention of arterial hypertension.

The TOTUM•854 clinical development program includes three clinical studies, whose results will be required in Europe and the United States for health claim applications in the reduction of blood pressure, which is a risk factor for cardiovascular disease. The clinical protocols for the three studies have been filed with the competent authorities.

The INSIGHT international, multicenter, randomized, placebo-controlled Phase II/III clinical study will be conducted in a population of 400 volunteers with mild to moderate blood pressure elevation (systolic blood pressure between 130 mmHg and 159 mmHg and diastolic pressure <100 mmHg). It will include two groups: a TOTUM•854 group with a dose of 3.7 g/day and a placebo group. Its main objective will be to reduce systolic blood pressure in the TOTUM•854 group after 3 months of supplementation versus the placebo group. 24-hour ambulatory blood pressure measurements will also be taken as a secondary study endpoint. The end of recruitment is expected at the first semester of 2023.

A second INSIGHT 2 international, multicenter, randomized, placebo-controlled study will be conducted on 400 additional subjects with the same inclusion criteria. It will include two groups: a TOTUM•854 group with a dose of 2.6 g/day and a placebo group. Its main objective will be to reduce systolic blood pressure in the TOTUM•854 group after 3 months of supplementation versus the placebo group. It will thus assess the effect of a reduced dose of TOTUM•854 (2.6 g/day) on blood pressure. The end of recruitment is expected at the first semester of 2023.

The clinical study of the bioavailability and mode of action of TOTUM•854, to characterize its metabolites and identify their effects on human cell lines, will be conducted in France on 10 volunteers. The results are expected at the end of 2022.

Murielle CAZAUBIEL, Member of the Board of Directors and Director of Medical, Regulatory and Industrial Affairs at Valbiotis, said: “TOTUM•854’s clinical development plan is very ambitious, but meets the health challenges of preventing arterial hypertension, which the World Health Organization considers to be the world’s most prevalent chronic disease. It is a very important risk factor for cardiovascular disease. TOTUM•854 could quickly become an extremely interesting non-drug alternative for people at risk, whether or not they are already taking treatment. This innovative active substance, which contains six plant extracts, is designed to act on blood pressure regulation mechanisms. It would ultimately be produced in various dry forms, including as capsules.”

Sébastien BESSY, Member of the Board of Directors and Chief Operating Marketing and Business Officer at Valbiotis, comments: “TOTUM•854 will open the door to a major market worth over €1.15 billion 1 in the United States and in the five main European countries (Germany, Spain, France, Italy and the United Kingdom), where no fewer than 124 million people suffer from mild to moderate arterial hypertension. This clinical development plan will leverage the potential of TOTUM•854 in preventing arterial hypertension, with the aim of bringing it to market as soon as the studies ends. In addition, we have registered TOTUM•854 in over 60 countries, including our key territories such as the United States, Europe, Mexico, China, Japan and already obtained in some of these territories.”

Valbiotis presented its preclinical data on the active substance TOTUM•854 at the annual meeting of the European Society of Hypertension and of the International Society of Hypertension in April 2021. The in vivo results obtained from two predictive models of hypertension in humans showed that TOTUM•854 effectively prevented arterial hypertension. This proof-of-concept was obtained in partnership with the Cardiovascular Pharm-Ecology Lab (LaPEC) of the University of Avignon and at the Valbiotis R&D platform. The research presented at the meeting was conducted on a model of L-NAME-induced hypertension (an NO synthase inhibitor). In this classic model of hypertension, predictive of human physiology, TOTUM•854 prevented the onset of arterial hypertension compared with the control group. Additional data, obtained from a polygenic SHR (spontaneously hypertensive rat) model of hypertension, also showed a positive effect of TOTUM•854 that delays the development of hypertension.

A significant acute effect was also observed following a single dose of TOTUM•854 on the same SHR model.

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
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 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.


1 Source: AEC Partners pre-AHT preliminary market estimate 2020 data

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

Contact information

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Specifica Validates Best-in-Class Status for in vitro Antibody Discovery Platform in Two Key Peer Reviewed Publications29.1.2022 02:00:00 EET | Press release

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody library and discovery tools, announced the publication of two peer-reviewed articles describing its Generation 3 Antibody Discovery Platform1,2. Antibodies are the fastest growing class of therapeutics, representing nine of the top twenty best-selling drugs3. The global antibody therapy market is projected to grow from $178.50 billion in 2021 to $451.89 billion in 2028 at a CAGR of 14.1%4. Traditionally, therapeutic antibodies have been generated by harvesting immune responses, either from in-bred or transgenic mice, or from immune human subjects. Although there has been a long-standing interest in using in vitro antibody library approaches that avoid the use of animals, there have been two main concerns with antibodies from in vitro libraries: binding affinities tend to be lower, and poor developability characteristics are common, complicating their development as successful drugs. As desc

ADVA Optical Networking SE: Acorn HoldCo, Inc. reaches minimum acceptance threshold for its public exchange offer to all shareholders of ADVA Optical Networking SE29.1.2022 01:45:00 EET | Press release

ADTRAN, Inc. today announced that by the end of the acceptance period on January 26, 2022, 24:00 hours (local time Frankfurt am Main), the voluntary public takeover offer of Acorn HoldCo, Inc. (“Bidder”) to all shareholders of ADVA Optical Networking SE (“ADVA“) has been accepted for more than 60% of all ADVA shares entitled to voting rights and existing as of October 31, 2021. The minimum acceptance threshold has therefore been reached. The final result as at the end of the acceptance period is expected to be published on January 31, 2022. ADTRAN, Inc. and ADVA have thus reached yet another important milestone for the merger of the two companies and have come closer to their goal of creating a leading company in the field of optical transmission technology for enterprise, access and wide-area networks. The consummation of the public exchange offer continues to be subject to closing conditions not yet fulfilled, especially foreign direct investment approval in Germany. ADVA shareholder

causaLens Raises $45m Series A to Scale Human-centered AI That Understands Cause-and-effect28.1.2022 17:46:00 EET | Press release

causaLens, the London deep tech company delivering the future of AI, has raised a $45m Series A round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220126005888/en/ The causaLens co-founders, Dr. Maksim Sipos, CTO, on the left, and Dr. Darko Matovski, CEO, on the right. (Photo: Business Wire) causaLens is the pioneer of Causal AI - the only AI technology quantifying cause-and-effect relationships to reason alongside humans in a manner that is trustworthy, explainable, and fair. Causal AI represents a giant leap ahead of current correlation-based AI technologies, which blindly extrapolate historical data and are unable to ask counterfactual questions — the ‘what ifs’ at the core of human imagination and creativity. causaLens’s no-code platform delivers far more accurate and reliable results, and allows humans and machines to work together for the first time. It is trusted by decision makers across finance, industry, technol

Monrol Signing Agreement to License its GMP Grade Lu-177 n.c.a Production Technology to Curium28.1.2022 15:47:00 EET | Press release

Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has today announced it has signed an agreement with Curium Netherlands B.V (Curium) to license its GMP grade medical radioisotope, no-carrier-added 177Lu (n.c.a. 177Lu) cutting-edge production technology LuMagic®. This agreement will enable transfer of relevant equipment and supply from Monrol to Curium. Monrol is one of the few producers of Lutetium-177 n.c.a worldwide, having uninterrupted worldwide supply capabilities. Monrol Lu-177 n.c.a production process is an exclusive processing technology having cleaner and safer production method with stable isotope enrichment capability. Curium planning to manufacture the product Lu-177 n.c.a in its Petten production facility, Netherlands. This licence is offering significant opportunities both for Curium; one of the world’s largest nuclear medicine companies and Monrol; a company which develops, manufactures, and distributes world-class radiopharmaceutical products, radioisotopes to improve qu

CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction28.1.2022 15:26:00 EET | Press release

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced today.1 Empagliflozin was previously approved for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).4 If approved, the positive opinion would expand this indication to be applicable for adults across the full spectrum of left ventricular ejection fraction (LVEF), including preserved ejection fraction (HFpEF). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220127005861/en/ “For the very first time, we now have a treatment that will improve clinical results across the full spectrum of heart failure patients – regardless of ejection fraction,” said Professor Stefan Anker, Heart Failure Car

Schlumberger DELFI Digital Platform Selected by Northern Lights JV for CO2 Project28.1.2022 15:00:00 EET | Press release

Schlumberger will deploy the DELFI* cognitive E&P environment on the Norwegian CO2 project by the Northern Lights Joint Venture (NL), to streamline subsurface workflows and longer-term modeling and surveillance of CO2 sequestration. NL was established to develop the world’s first open-source CO2 transport and storage infrastructure, providing accelerated decarbonization opportunities for European industries, with an ambition to store up to 5 million tonnes of CO2 per year based on market demand. For CO2 transportation and storage, Schlumberger digital solutions are used for subsurface characterization and dynamic reservoir simulation, which are key to understanding storage site capacity and the potential for injecting and containing fluids. They are also used for development planning, operations, appraisals, and monitoring purposes. “Northern Lights has recognized the huge potential of Schlumberger’s digital technology to fast-track decision making and de-risk CO2 transportation and st

Pixis Appoints Neel Pandya as the CEO for Europe Business, in Addition to APAC28.1.2022 14:28:00 EET | Press release

Pixis (formerly known as Pyxis One), a leading provider of contextual codeless AI infrastructure for complete marketing optimization, today appointed Neel Pandya as the Chief Executive Officer of its operations in Europe, in addition to his responsibilities of leading the APAC business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220128005166/en/ Neel Pandya joined Pixis as the CEO of APAC in its Bengaluru office after exiting L'Oréal. (Photo: Business Wire) Neel joined Pixis in its Bengaluru office in July 2021 as the CEO of APAC, bringing immense change and progress to the way Pixis operates, and greatly streamlining expansions in the APAC region. Under his leadership, Pixis witnessed a 185% growth in revenue in the APAC region, with India independently recording a 150% of growth. Over the last 7 months, in addition to greatly stabilizing customer churn Neel has also been instrumental in adding close to 30 new enterpris

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom