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
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
Credit Derivatives Determinations Committees Membership applications for 202627.3.2026 17:30:00 CET | Press release
DC Administration Services, Inc. (DCAS) would like to invite all interested Members of ISDA to apply for a position as a member of the Credit Derivatives Determinations Committees. There is a separate Determinations Committee for each of the relevant regions. Members of ISDA may apply for membership as either a Dealer Member of the Determinations Committees or a Non-Dealer Member of the Determinations Committees (as applicable). Parties wishing to apply for such a position should carefully review and submit either an executed Dealer Participation Letter (for a prospective Dealer Member) or an executed Non-dealer Committee Participation Letter (for a prospective Non-Dealer Member) by 5pm (New York time) on Friday, April 3, 2026. CCPs may also apply to participate as a CCP Member by submitting a Participating CCP Institution Letter. For more information on the process and to download the form of the relevant letter, please visit https://www.cdsdeterminationscommittees.org/about-dc-commit
Andersen Consulting indgår samarbejdsaftale med Solutia27.3.2026 15:22:00 CET | Pressemeddelelse
Andersen Consulting udvider sin tilstedeværelse i Spanien gennem en samarbejdsaftale med Solutia, en virksomhed med speciale i løsninger inden for arbejdsmiljø og sundhed samt rekruttering inden for life science- og sundhedssektoren. Solutia blev stiftet i 2014 og tilbyder omfattende tjenester og rådgivning med fokus på sunde arbejdsmiljøer, sygefravær, outsourcing af sundhedsydelser og uddannelse til organisationer på tværs af alle sektorer. Virksomheden leverer også rekrutterings- og executive search-løsninger med fokus på life science, tekniske fagfolk samt mellem- og topledelse samt dybdegående ekspertise inden for medicinal-, bioteknologi-, medico- og sundhedsindustrien. Ved hjælp af datadrevne og skræddersyede løsninger hjælper Solutia virksomheder med at optimere medarbejdereffektiviteten og tiltrække specialister. "Vores mål er at forbedre, hvordan organisationer tiltrækker, udvikler og leder medarbejdere i et stadig mere komplekst miljø," udtalte Cesar Castel, administrerende
Klarna Partners With EuroParcs to Offer Flexible Payments for Holiday Park Stays Across Europe27.3.2026 15:04:00 CET | Press release
Klarna, the global digital bank and flexible payments provider, today announces a new partnership with EuroParcs, one of Europe's fastest-growing holiday park operators. The collaboration gives holidaymakers in Germany, the Netherlands, Belgium, and Austria more flexibility in how they pay for their getaway. Guests booking through EuroParcs can now choose from a range of Klarna payment options tailored to their market: Germany & Austria: Pay in Full, Pay in 30 Days, Pay in 3, and Financing Netherlands: Pay in Full, Pay in 30 Days, and Pay in 3 Belgium: Pay in Full and Pay in 30 Days Nicole Defren, Head of Europe at Klarna, says: "Booking a holiday should feel exciting, not complicated – and that includes how you pay for it. With Klarna, EuroParcs guests can choose the payment option that suits them best, whether that's paying upfront, in a few weeks, or spreading the cost over time. From a cosy chalet on the Veluwe to a luxury villa in the Austrian Alps, we're making it easier for fami
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