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
Compass Pathways Commends White House Executive Order to Accelerate Research and Access for Psychedelic Treatments18.4.2026 22:12:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, welcomes the White House Executive Order on accelerating medical treatments for serious mental illness. “We commend the Administration’s Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have,” said Kabir Nath, CEO at Compass Pathways. “Today’s announcement aligns regulatory urgency with patient need, and we applaud the Administration for taking this important step forward in accelerating access, without compromising rigorous science. Compass is conducting the largest, most robust classic psychedelic studies to date with COMP360 synthetic psilocybin. We have recently reported two positive phase 3 trials in treatment-resistant depression (TRD) with highly statistically significant and clinically meaningful data that
2026 NAB Show Opens Tomorrow, Uniting Global Media Leaders to Shape the Future of Storytelling18.4.2026 04:08:00 CEST | Press release
CEO of Zhong, one of YouTube’s most-watched creators with 70 million subscribers and 95 million followers on all platforms, joins program The 2026 NAB Show kicks off Saturday, April 18, with the show floor and exhibits opening on April 19, highlighting the most innovative companies and bringing together the world’s most influential voices across media, entertainment and technology for the industry’s premier global event. As the only platform that convenes broadcasters, media companies, content creators and technology innovators at scale, NAB Show continues its century-long legacy as the catalyst for innovation, growth and deal-making in a rapidly evolving, multi-platform world. From artificial intelligence and the creator economy to sports, streaming and cloud transformation, NAB Show is where the tools, talent and ideas driving the future of storytelling converge. “NAB Show is where the global media ecosystem comes together not just to explore what’s next—but to build it,” said Karen
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product17.4.2026 23:43:00 CEST | Press release
A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.In their order, FDA concluded that: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals” The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes. The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit th
Canva Announces Anthropic Collaboration to Bring AI-Powered Design to Millions17.4.2026 17:51:00 CEST | Press release
New collaboration brings Canva into Claude Design by Anthropic, turning AI-generated ideas into fully editable, on-brand designs Canva, the world’s leading all-in-one visual communication platform, today announced the next chapter in its two-year strategic collaboration with Anthropic, bringing Canva directly into the newly launched Claude Design by Anthropic Labs, one day after unveiling Canva AI 2.0 to a crowd of 6,500 people at Canva Create in Los Angeles.. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260410843169/en/ Canva and Claude Canva is also today introducing HTML importing, a new capability that makes it easy to bring interactive content generated in tools like Claude into the Canva editor for drag-and-drop collaboration, refinement, and publishing. The collaboration makes it easier for Claude Design users to turn AI-generated drafts and ideas into fully editable designs in Canva, where they become collaborative
Andersen Consulting tilføjer samarbejdsfirmaet Nuvolar17.4.2026 15:43:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform for digitale transformation gennem en samarbejdsaftale med Nuvolar, et teknologikonsulenthus med speciale i cloudbaseret softwareudvikling og avancerede Salesforce-implementeringer. Nuvolar, der blev stiftet i 2008 og har hovedsæde i Spanien, leverer end-to-end digital produktudvikling med dyb ekspertise inden for Salesforce, specialudviklede web- og mobilapplikationer, full-stack udvikling, UX/UI-design, produktledelse og langsigtede supporttjenester. Med mere end 110 fagfolk fordelt over Barcelona, Madrid, Miami og Mexico City arbejder virksomheden med kunder inden for luftfart, sundhedsvæsen, forbrugsgoder, medicinalindustrien samt hotel- og restaurationsbranchen for at designe og implementere skalerbare, forretningskritiske platforme, der optimerer driften og fremskynder den digitale transformation. "Samarbejdet med Andersen Consulting giver os mulighed for at levere vores ekspertise i en større skala," udtalte Marc Vivas, administrerende di
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