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
LZE GmbH Introduces Fraunhofer’s RFicient® Technology to the Market12.3.2026 14:51:00 CET | Press release
LZE GmbH is expanding its technology transfer portfolio and making the RFicient® ultra-low-power wake-up receiver technology from the Fraunhofer Institute for Integrated Circuits IIS available for the first time as a standard chip for close-to-production industrial applications. The solution enables energy-efficient IoT designs that remain continuously reachable while consuming only microamps – a key step for long-lasting, low-maintenance IoT products. LZE GmbH drives technology transfer to market: standard chip availability for close-to-production applications As a bridge between research and industry, LZE GmbH is making it easier for companies to access innovative technologies and helping them to quickly and reliably transform new developments into market-ready solutions. With RFicient®-IC (FH101RF), LZE is providing another high-tech product that comes directly from Fraunhofer research and can now be ordered in volume and integrated into close-to-production product development for t
Owkin Creates New Spin out Waiv, Formerly Owkin Dx, With $33M Financing12.3.2026 14:30:00 CET | Press release
Investment lead by OTB Ventures and Alpha Intelligence CapitalWaiv develops AI-powered precision testing to better identify and stratify patients in the clinic and in clinical trials, transforming patient careWaiv extends Owkin’s strategy of real-world validation for its AI Owkin, the AI company on a mission to solve the complexity of biology, today announced the spin out of Waiv, formerly known as Owkin Dx. The move follows significant investor interest and positions Waiv to bring AI-powered precision testing for better identification of patients in the clinic and in clinical trials, to transform patient care. This follows on from the successful launch of Bioptimus, an Owkin incubated company, in February 2024. Waiv translates AI innovation into real-world clinical impact, developing tests that predict biomarkers and patient outcomes, including RlapsRisk BC for prognostic risk profiling. With multiple tests already in use in clinical settings, its deployment platform Destra, and colla
RQM+ Launches SMART Solutions Life Cycle Partnership Model12.3.2026 14:30:00 CET | Press release
Helps MedTech Companies Navigate MDR, IVDR, and AI-Enabled Device Development RQM+, a leading MedTech CRO offering regulatory consulting, clinical trial, laboratory, and reimbursement services, today announced the launch of SMART Solutions, a life cycle partnership model designed to help medical device and diagnostics companies manage growing regulatory and development complexity. SMART Solutions introduces a strategy-led operating framework that unifies regulatory, quality, clinical, reimbursement, and laboratory expertise to support MedTech companies across the entire product life cycle to help reduce risk from early development through post-market. “MedTech companies are navigating unprecedented complexity as regulatory expectations evolve, product innovation accelerates, and post-market expectations are expanding,” said John Potthoff, Ph.D., chief executive officer of RQM+. “SMART Solutions moves beyond traditional consulting by providing an integrated life cycle partnership that h
Cryptio Raises $45m Series B as Digital Assets Move Into Regulated Financial Markets12.3.2026 14:06:00 CET | Press release
The system of record for tokenized finance – ERP infrastructure for institutions operating in digital assets Cryptio, a leader in financial data transformation and enterprise resource planning (ERP) applications for regulated digital assets, announced today a $45 million Series B funding round co-led by BlackFin Capital Partners and Sentinel Global, with participation from 1kx, Alven, BlueYard Capital and Ledger Cathay Capital. Banks, exchanges, asset managers, including Société Générale’s SG Forge, Circle, Gemini, and Securitize rely on Cryptio to ensure financial integrity across their digital assets businesses. Existing ERP systems fall short for digital assets Traditional ERP and accounting systems were not designed for blockchain-native assets, real-time reporting, or modern custody frameworks. As regulated financial institutions expand into stablecoins, tokenized securities and other on-chain instruments, these limitations create material operational and reporting challenges. Cry
HyperLight Introduces 145 GHz Reference Modulators to Enable 448Gbps per Lane Datacom and 260GBaud Telecom Development12.3.2026 14:03:00 CET | Press release
HyperLight Corporation, creator of the TFLN Chiplet™ platform, today announced the release of its 145 GHz Packaged Intensity Modulator (IM), expanding the company‘s high-speed modulator portfolio. The new device is designed for ultra-wide modulation bandwidth, high signal fidelity, and stable operation control, enabling 448 Gbps per lane intensity-modulated-direct-detection (IMDD), 260 GBaud coherent links, and broadband RF photonics systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312319685/en/ Fig. 1: HyperLight’s 145 GHz intensity modulator for 448Gbps per lane IMDD and 260GBaud coherent applications, with operational electro-optical bandwidth >145GHz, stable bias control, 0.8 mm-connector; available in O-, C-, and L-bands. As symbol rates and analog bandwidth requirements continue to rise across data center interconnects, AI-driven photonics infrastructure, and laboratory test environments, system architects in
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