VALBIOTIS
22.2.2021 17:42:09 CET | Business Wire | Press release
Regulatory News:
VALBIOTIS (FR0013254851 – ALVAL / eligible for the PEA/SME) (Paris:ALVAL), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the First Patient's First Visit in the Phase II HEART clinical study evaluating TOTUM-070, an innovative active substance for the reduction of blood LDL-cholesterol levels, a risk factor for cardiovascular disease.
The Company is stepping up development of TOTUM-070 in 2021, with the completion of a complementary clinical study and preclinical work on lipid metabolism. These preclinical results will be submitted to the American Heart Association (AHA) meeting at the end of the year.
Murielle CAZAUBIEL, member of the Management Board and Director of Development and Medical Affairs at VALBIOTIS, comments: “The start of recruitment for the Phase II HEART clinical study kicks off a decisive year for the development of TOTUM-070. This study should demonstrate the clinical efficacy of our active substance against excess blood LDL-cholesterol, a major risk factor for cardiovascular disease worldwide. Pending these results in early 2022, and given the potential of TOTUM-070, we have decided to conduct several complementary clinical and preclinical studies simultaneously this year. This is an ambitious program, which should provide a maximum amount of data by early next year and confirm TOTUM-070 as an additional innovation for people at risk of cardiovascular disease.”
The randomized, double-blind, placebo-controlled, multicenter, Phase II HEART clinical study is designed to evaluate the efficacy of a 5g daily dose of TOTUM-070 on blood LDL-cholesterol levels, its primary endpoint. The study will include 120 people with LDL-cholesterol levels between 130 and 190 mg/dL. Results are expected in early 2022.
Development of TOTUM-070 stepped up in 2021
Simultaneously with the HEART study, VALBIOTIS has decided to conduct a complementary clinical study to expand knowledge of TOTUM-070 and its effects on lipid metabolism in humans. Conducted on a limited number of volunteers, it will combine a bioavailability study, metabolomic analysis (characterization and quantification of TOTUM-070 metabolites) and targeted ex-vivo mode of action tests on human cell models, mainly hepatic. Results are expected before the end of 2021.
Finally, a series of preclinical experiments will be launched and completed in 2021. Conducted on the VALBIOTIS R&D platform, this work is intended to detail the impact of TOTUM-070 on lipid metabolism in a predictive model of human pathophysiology. The results will be submitted to the annual meeting of the American Heart Association (AHA), the leading American learned society in the cardiovascular field, to be held from November 13 to 15, 2021.
Once development is complete, TOTUM-070, a new Health Nutrition product, will be positioned for individuals with LDL-hypercholesterolemia, at levels up to 190 mg/dL, with a moderate overall cardiovascular risk. At the end of 2020, the Company provided detailed market data on hypercholesterolemia and the role of TOTUM-070 in its management (see press release of October 27, 2020 ).
ABOUT THE HEART STUDY
The Phase II HEART clinical study is designed to evaluate the efficacy of a 5g daily dose of TOTUM-070 on blood LDL-cholesterol levels, a risk factor for cardiovascular disease, in the absence of lipid-lowering treatment.
This randomized, double-blind, placebo-controlled, multicenter study will include 120 people with untreated moderate hypercholesterolemia and blood LDL-cholesterol levels 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 metabolic secondary endpoints of interest.
ABOUT TOTUM-070
TOTUM-070 is an innovative active substance derived from food plant extracts, without phytosterols or red rice yeast, developed to act on lipid metabolism in hypercholesterolemic individuals.
Once development is complete, this new Health Nutrition product will be positioned in particular for people with LDL-hypercholesterolemia, at levels up to 190 mg/dL, with a moderate overall cardiovascular risk. TOTUM-070 may be recommended in this large population for whom no first-line drug treatment is currently recommended, with the aim of reducing LDL-cholesterol levels and thus overall cardiovascular risk.
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: www.valbiotis.com
.
Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-PME 150
DISCLAIMER
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 (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/20210222005407/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
Union of Kansai Governments: Kansai Deep Tech Ecosystem Gains Global Visibility31.3.2026 02:00:00 CEST | Press release
Platform Update Reflects 20-Place Rise in GSER Ranking The Union of Kansai Governments has refreshed the Kansai Startup Ecosystem portal, strengthening the region’s global communication platform for startups and deep tech. At the same time, the “DeepTech Frontier Kansai” website has also been updated, further enhancing international visibility for Kansai’s rapidly growing deep tech ecosystem. Kansai’s startup ecosystem has demonstrated steady growth in recent years. The ecosystem’s total value expanded from USD 2.68 billion in 2023 to USD 3.23 billion in 2025. In addition, Kansai rose 20 places in the Global Startup Ecosystem Ranking (GSER) published by Startup Genome, climbing from 99th in 2023 to 79th in 2025, and early-stage funding reached USD 124 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330459051/en/ Kansai’s Strength in Deep Tech Kansai represents a rare ecosystem where fundamental research and indust
Merz Aesthetics® Announces EU Approval of Two New Indications for Their Hyaluronic Acid Filler BELOTERO® Balance30.3.2026 22:49:00 CEST | Press release
Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, is pleased to announce that BELOTERO® Balance has received EU approval for two additional indications: the treatment of infraorbital hollow (including the tear trough) and horizontal forehead lines1*. “With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications1 designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” said Dr. Kerstin Olsson, Head of Medical Affairs EMEA. The approval of these two new indications is supported by compelling clinical evidence: In a clinical investigation on infraorbital hollow, 98.9% of subjects demonstrated visible improvement at Week 8, with long-lasting results sustained up to 72 weeks, and no treatment related serious adverse events reported.2 Similarly, in a postmarket investigation on horizontal forehead lines, 82.
Klarna Payments Now Available at B-Parts, Europe's Largest Automotive Parts Website30.3.2026 21:51:00 CEST | Press release
B-Parts is now offering its customers a more personalised and flexible shopping experience, with interest-free payments via "Pay in 3", amongst other Klarna features. Klarna, the global digital bank and flexible payments provider, is joining forces with B-Parts, a leading online retailer of used and original car parts, to offer consumers greater flexibility, convenience, choice and control at the point of payments, with no interest or hidden fees. Through Klarna’s interest-free installment payments, B-Parts customers will benefit from greater flexibility and control over their finances. Klarna also ensures a secure shopping experience thanks to its buyer protection scheme, as well as a range of features such as cashback and deals. "We continue to grow locally, with an increasing number of brands across different sectors recognising the enormous advantage of offering their customers more payment options, those that make for a more convenient and seamless checkout experience," explains I
Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings & Gatbits IT Infrastructure Announce Launch of GTBS Digital Ecosystem; Mainnet Set for April 202630.3.2026 20:30:00 CEST | Press release
The Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings, in collaboration with Gatbits IT Infrastructure, has officially announced the launch of the GTBS Digital Ecosystem, marking a significant step forward in the global Web3 space. The announcement follows the successful launch of the native GTBS Coin on December 25, with the ecosystem’s mainnet scheduled to go live in April 2026. GTBS represents a full-stack Web3 ecosystem integrating blockchain, artificial intelligence, decentralized finance (DeFi), entertainment, gaming, media, and cloud infrastructure into a unified platform. Built on the philosophy of “All Commitment On Time,” the ecosystem focuses on delivering reliability, scalability, and real-world utility. Designed as a comprehensive digital infrastructure, GTBS goes beyond standalone crypto platforms by offering an integrated environment for users, developers, creators, and enterprises. Its proprietary Layer-1 blockchain powers seamless interaction across se
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
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