VALBIOTIS
15.2.2021 17:42:03 CET | Business Wire | Press release
VALBIOTIS (FR0013254851 – ALVAL / eligible for the PEA/SME, French equity savings plan for the financing of SMEs) (Paris:ALVAL), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has received a positive opinion from the CPP and authorization from the ANSM to launch HEART, a multi-centric Phase II clinical study with TOTUM-070, for the reduction of blood LDL-cholesterol levels, a risk factor for cardiovascular disease.
The main objective of this clinical study is to evaluate the efficacy of a 5g daily dose of TOTUM-070 and to confirm its safety. HEART results will support the application for a proprietary health claim related to the reduction of LDL-cholesterol, a risk factor for cardiovascular disease.
These authorizations make it possible to begin enrolling 120 people with untreated mild to moderate LDL-hypercholesterolemia in the study.
Professor Jean-Marie Bard, PharmD, PhD, Professor and Hospital Practitioner at Nantes University Hospital, scientific advisor for the Phase II clinical study, declared: “The need for an additional, effective and well-tolerated tool in the clinical arsenal to rapidly reduce LDL-cholesterol without waiting for the situation to deteriorate is currently not fully met. TOTUM-070 offers, in this regard, new promise for patients with genuine cardiovascular risk. By acting on LDL-cholesterol, the risk of cardiovascular events is reduced with a positive impact on life expectancy. Improving cardiovascular prognosis is a major public health challenge. As an advisor to the HEART study, I have high hopes for the ability of TOTUM-070 to significantly reduce bad cholesterol levels in the blood.”
Murielle Cazaubiel, member of the Management Board, Head of Development and Medical Affairs at VALBIOTIS, added: “VALBIOTIS is very proud to bring its second active substance, TOTUM-070, to the Phase II clinical stage. The design of the HEART study will provide unequivocal proof of the efficacy of this active substance in hypercholesterolemic patients. This is a key milestone in the development of TOTUM-070 and an exciting prospect for those awaiting alternative solutions. With this second innovative active substance, VALBIOTIS consolidates its breakthrough position in the prevention of metabolic diseases.
We wish to warmly thank all the healthcare professionals involved in this study.”
The Phase II randomized, double-blind, placebo-controlled clinical study will include 120 people with untreated moderate hypercholesterolemia between 130 and 190 mg/dL. Participants will be divided into 2 equivalent arms of 60 people, supplemented for 6 months with TOTUM-070 or placebo. The primary endpoint of the study will be the reduction of blood LDL-cholesterol levels, with several secondary objectives of interest.
Results are expected at the beginning of 2022.
In line with VALBIOTIS' business model, the objective is to conclude a partnership and license agreement for the marketing of TOTUM-070 with a global healthcare player. In February 2020, this model enabled VALBIOTIS to sign a strategic partnership with Nestlé Health Science for the active substance TOTUM-63, aimed at reducing the risk of type 2 diabetes in prediabetic individuals.
ABOUT TOTUM-070
TOTUM-070 is an innovative active substance derived from food plant extracts, free from phytosterols and red rice yeast, developed to act on lipid metabolism in hypercholesterolemic subjects.
This exclusive active substance is especially developed for people with mild to moderate LDL-cholesterol levels, up to 190 mg/dL, untreated and associated with a moderate overall cardiovascular risk.
TOTUM-070 benefits from intellectual property backed by patents in the world's main markets: Europe, the United States, Russia, South Africa and national phases in progress in the United Arab Emirates, Brazil, Canada, Japan, China, Australia and Mexico.
The goal of TOTUM-070 clinical development is to obtain a proprietary health claim related to the reduction of blood LDL-cholesterol, a risk factor for cardiovascular disease.
Excess LDL-cholesterol is a widespread cardiovascular risk factor, found in nearly 40% of the world's adult population, according to WHO data.
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 nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top 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 received “Innovative Company“ status awarded by BPI France. 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.
Find out more about VALBIOTIS: www.valbiotis.com
Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-SME 150
DISCLAIMER
This press release contains forward-looking statements about VALBIOTIS’ objectives, 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 affected by 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 120-018). This document is available on the Company’s website (www.valbiotis.com
).
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210215005131/en/
About Business Wire
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
ProAmpac Pushes the Limits of Fiber Packaging with New High Barrier Packaging Innovation Platform17.2.2026 18:08:00 CET | Press release
ProAmpac, a global leader in flexible packaging and material science, announces the expansion of its ProActive Recyclable® RP-2000 High Barrier Series. This curbside recyclable, fiber-based packaging platform is designed to help brands transition away from traditional non-recyclable high-barrier multilayer structures, such as paper/foil, paper/metalized polyethylene terephthalate (METPET), and certain film laminations. The RP-2000 platform provides strong barriers to oxygen and moisture, making it well-suited for sensitive dry food products such as oatmeal, granola, cereal, spices, snacks, dried fruits, and nuts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260217779741/en/ ProAmpac's RP-2000MHB Series “Supporting the growing Fiberization of Packaging® movement, and as adoption of fiber-based structures accelerates, it is critical that ProAmpac continues to expand the functional performance envelope of paper-based material
ChipAgents Raises $74M to Scale an Agentic AI Platform to Accelerate Chip Design17.2.2026 16:00:00 CET | Press release
Company opens 20,000 sq ft HQ in Silicon Valley to deploy AI Agents to accelerate chip design workflows. Sandeep Bharathi joins Advisory Board. ChipAgents, the category leader for Agentic AI platforms in the semiconductor design industry, announced it has closed an oversubscribed $50 million Series A1 funding round, bringing total capital raised to $74 million. The round was led by Matter Venture Partners, a TSMC-backed HardTech VC firm, with participation from existing investors Bessemer Venture Partners, Micron, MediaTek, and Ericsson. As part of the investment, Wen Hsieh, Founding Managing Partner of Matter VP, will join ChipAgents' Board of Directors, bringing over two decades of expertise and relationships in semiconductor design and manufacturing. Building the AI Workforce for Chip Design Companies This new capital will enable ChipAgents to aggressively scale its Agentic AI platform, expand its engineering and research organization, and accelerate global deployment of multi-agent
Toshiba Showcases End-to-End Innovations Shaping What’s Next in Retail at EuroShop 202617.2.2026 15:45:00 CET | Press release
At EuroShop, Toshiba showcases intelligent, scalable solutions that combine AI, computer vision, and energy-efficient design to transform the future of retail. At EuroShop 2026, Toshiba Global Commerce Solutions will showcase how retailers across Europe are using scalable, sustainable innovation to address today’s challenges and build what’s next. Exhibiting in Hall 6, Booth C41 from the 22nd to 26th February, Toshiba will demonstrate technologies designed to evolve with retailers, empowering flexibility, resilience, and long-term growth, and prepare them for what’s next. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260216755053/en/ At EuroShop, we’re showing how Toshiba empowers retailers across all segments to transform with confidence by scaling intelligent solutions to deliver lasting impact. “Retailers are under pressure to move faster, operate more efficiently, and deliver better experiences than ever before. At Euro
Andersen Consulting Expands Executive Talent Capabilities With Lansdowne Executive Search17.2.2026 15:30:00 CET | Press release
Andersen Consulting strengthens its human capital practice through a Collaboration Agreement with Lansdowne Executive Search, a Dublin-based firm specializing in executive search, interim management and board level appointments. Founded in 2015, Lansdowne Executive Search is an Irish-owned firm, delivering C-level executive search, fractional executives, and board placement services. As a partner-led, boutique practice, Lansdowne is known for the deep involvement of senior leadership in all client engagements. Lansdowne helps clients navigate complex leadership transitions and growth strategies across a wide range of sectors including financial services, construction, nonprofit, agriculture, higher education, public sector, and TMT. “Great leadership is contextual and getting it right means understanding far more than just a resume,” said Tom Keane, partner at Lansdowne Executive Search. “Collaborating with Andersen Consulting gives us the scale and access to expertise we need to conti
Caidya Names Michael Clay COO to Drive Operational Excellence and Advance Multi-Regional Clinical Development17.2.2026 15:10:00 CET | Press release
Caidya, a leading global, mid-sized CRO focused on accelerating clinical development for innovative biopharmaceutical companies, today announced the appointment of Michael Clay as chief operating officer (COO). Clay will lead Caidya’s global operational delivery, client engagement model, and execution strategy, further strengthening the company’s ability to serve innovative biopharma sponsors across the U.S., Europe, and Asia-Pacific. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260217431202/en/ Michael Clay, Caidya's Chief Operating Officer Clay brings a distinguished track record in global project delivery and site relationship strategy. He has led large-scale global programs across 60+ countries and built high-performing delivery organizations known for operational rigor and sponsor trust. Notably, Clay has extensive leadership experience across Asia-Pacific, where speed, regulatory nuance, and close site collaboration
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