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
Armis Centrix™ Named “Best Solution” for Cyber Exposure Management as Armis Wins Multiple Global InfoSec Awards at RSAC 202623.3.2026 17:00:00 CET | Press release
Armis awarded “Publisher’s Choice Cybersecurity Company”Yevgeny Dibrov received “Industry Pioneering CEO” Armis, the cyber exposure management & security company, today announced that it has won multiple Global InfoSec Awards from Cyber Defense Magazine at this year’s RSAC™ Conference. Armis received the following accolades: Armis Centrix™ won “Best Solution” for Cyber Exposure Management Armis named “Publisher’s Choice Cybersecurity Company” Yevgeny Dibrov, Armis’ CEO and Co-Founder, awarded “Industry Pioneering CEO” “We cannot safeguard modern infrastructure with yesterday’s tactics; the extended attack surface demands a unified, AI-driven approach that sees, protects and manages all assets (IT, OT, IoT, IoMT, applications, code, cloud and AI) in real time,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “Armis secures the most complex environments of organizations and governments worldwide to protect society from the destruction cybercriminals seek to cause. These awards reinforc
STOKR Appoints Subhankar Sinha as Senior Advisor23.3.2026 15:00:00 CET | Press release
Former BNY and PwC blockchain leader appointed to advance fund tokenization and STOKR's U.S. institutional expansion STOKR has appointed Subhankar Sinha as Senior Advisor. Sinha will work directly with STOKR's leadership team on fund tokenization with particular focus on money market fund (MMF) tokenization and on expanding STOKR's institutional presence in the U.S. market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323315236/en/ Image, Subhankar Sinha A New York-based digital assets executive, Sinha brings deep expertise across blockchain infrastructure, capital markets, and institutional business development. He previously served as Head of Blockchain at BNY, the world's largest custody and asset servicing business. Earlier in his career, he was a Director at PwC, where he co-founded and co-led the firm's blockchain consulting practice in the U.S. "Subhankar brings the institutional depth that this stage of STOKR's
Xsolla Partners With Cyprus Game Makers Association (CYGMA) as the Island Emerges as a Game Development Hub23.3.2026 14:00:00 CET | Press release
Strategic Partnership Equips Cyprus-Based Developers With the Commerce Infrastructure to Compete Globally Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced a strategic partnership with the Cyprus Game Makers Association (CYGMA). The collaboration will provide creators and studios within the CYGMA network with hands-on support, industry expertise, and access to world-class commerce tools, helping Cyprus-based studios bring their titles to players worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323570679/en/ Graphic: Xsolla The partnership comes as Cyprus continues to attract game development talent, fueled by favorable business conditions and a growing creative community. Through its collaboration with CYGMA, Xsolla aims to accelerate momentum and expand opportunities for developers by removing commerce and distribution barriers that often p
Exein Unveils Next-Generation Runtime Security to Protect the AI-Native World23.3.2026 14:00:00 CET | Press release
Photon blocks cyberattacks before execution across physical AI and IoT, autonomous AI agents and cloud and edge infrastructure Kernel-level prevention sets a new standard beyond traditional user-space detection Builds on Exein’s position as the world’s largest runtime security provider, protecting over two billion devices Exein, the global leader in runtime cybersecurity, today unveiled Photon, a preemptive breakthrough solution that blocks cyberattacks at the point of execution. Designed for the AI-native world - where digital and physical systems are now inseparable - Photon marks a fundamental shift in how critical infrastructure protects itself. Unlike traditional cybersecurity solutions that detect threats after compromise - typically operating in user space and relying on a cloud network - Exein’s Photon operates directly inside the kernel, preventing malicious execution paths before they can run. By blocking attacks before the point of execution, the technology dramatically redu
Manhattan Associates’ 2026 Unified Commerce Benchmark Reveals the High Price of Standing Still in Retail23.3.2026 13:30:00 CET | Press release
Leaders achieve up to 2X revenue growth, but only 7% of retailers are true unified commerce leaders Manhattan Associates Inc. (NASDAQ: MANH), today announced the findings of its 2026 Global Unified Commerce Benchmark for Specialty Retail, the industry’s most comprehensive assessment of how well retailers connect digital and physical experiences to drive growth, profitability and loyalty. Conducted by Incisiv, a leading retail research firm, the Benchmark is based on real-world purchases and returns. It analyzes more than 400 specialty retailers across EMEA, LATAM and North America on 330 capabilities spanning four key experience areas: Shopping, Checkout, Fulfillment, and Service. The 2026 Benchmark reveals that while the industry has made steady progress in unified commerce maturity since 2023 when it was first launched, only 7% of retailers have achieved true unified commerce leadership while 33% are still stuck in the Basic category. Leaders are translating connected, data‑driven ye
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