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
Ant International Secures Payment Institution Licence from the Central Bank of Brazil4.9.2026 16:41:00 CEST | Press release
Expanding the company’s capability to support local partners with FinAI solutions Ant International, the leading global digital payment, digitisation, and FinAI solutions provider, today announced that it has received a Payment Institution (PI) licence from the Central Bank of Brazil. “With the Central Bank's invaluable support, we are ready to step up more reliable and comprehensive global payment and account services to enterprises, platforms and SMEs in the country's dynamic digital economy, in ever deeper collaboration with its highly developed payments ecosystem and financial services industry,” said Rodrigo Reif, General Manager, Ant International Brazil. Ant International provides cross-border payments and account services, embedded credit and treasury services, and other finAI and blockchain solutions to clients across Asia, Europe and the Americas. The company processes over 20 million transactions daily, connecting 2 billion consumer accounts to 150 million global merchants v
Bending Spoons completes the acquisition of Airtable4.9.2026 14:30:00 CEST | Press release
Bending Spoons S.p.A. (NASDAQ: BSP) has completed the previously announced acquisition of Airtable, the platform used by more than 500,000 organizations to reshape how teams organize data and manage critical workflows. “Airtable continues to grow because customers value its best-in-class flexibility,” said Luca Ferrari, Bending Spoons CEO and co-founder. “Teams can bring all their data, context, and AI agents together in one place, shape their workflows around their specific needs, and progressively expand their use of the platform over time. As we take the reins, our focus will be on sustaining that growth by investing heavily in Airtable’s product, customer support, and go-to-market capabilities.” “I’m proud of what the Airtable team has built and excited to see the business enter this next chapter,” said Howie Liu, co-founder of Airtable. “I’m confident Bending Spoons has the resources and long-term perspective to help Airtable continue delivering exceptional value to its customers
EQT to acquire McGill and Partners, a leading specialty (re)insurance broker for USD 2.0 billion, from Warburg Pincus4.9.2026 13:48:00 CEST | Press release
Warburg Pincus and McGill and Partners have reached an agreement with EQT that will see Warburg Pincus sell its majority stake to EQT McGill and Partners founders, management team and colleagues will re-invest alongside EQT, retaining a meaningful ownership stake in the firm going forward as they continue to serve clients globally Maintains commitment to firm’s independent model and culture of ownership, developed organically since its founding in 2019 EQT will partner with Steve McGill and the management team to accelerate organic growth, including via talent recruitment, further development of technology and data capabilities, and expansion of innovative digital solutions EQT and McGill and Partners are pleased to announce that EQT X ("EQT") has entered into a definitive agreement to acquire a majority stake in McGill and Partners from Warburg Pincus for USD 2.0bn. Founder and Chief Executive Officer Steve McGill will continue to lead the firm, while Chairman John Lloyd will remain a
A Race Is Never Won Alone: With La Tavolata, Barilla Brings the Paddock Family Together on the Monza Grid4.9.2026 12:18:00 CEST | Press release
A nearly 100-meter-long dinner table hosted more than 200 guests for an evening celebrating collaboration, trust and the bonds built beyond competition. On Thursday evening ahead of the Formula 1® Italian Grand Prix, Barilla transformed one of the sport’s fastest and most competitive environments into a place where the Paddock Family took center stage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902463001/en/ La Tavolata by Barilla on the starting grid of the Monza circuit. More than two hundred people gathered around a single table: drivers, Team Principals, mechanics, engineers, strategists, safety and medical car drivers, personal trainers, tire technicians. The individuals whose collaboration, precision and trust shape every race, every decision and every performance. A nearly 100-meter table set with plates and pasta. With the first-ever Tavolata organized by Barilla and F1, people from across the Formula 1® ecosy
Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 20264.9.2026 11:30:00 CEST | Press release
Aqara, a global leader in IoT, today announced a new lineup of smart lighting products and a global community platform for smart space creators, at IFA 2026 in Berlin. The announcements reflect Aqara's ongoing vision for AI-driven spatial intelligence — spaces that understand their users and adapt to how people actually live in them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904365343/en/ Aqara Showcases The New Smart Lighting Series and Immersive Smart Home Experience at IFA 2026 The new lighting series — spanning indoor and outdoor use — integrates seamlessly with Aqara's existing ecosystem of sensors, switches, and hubs, bringing complete whole-space lighting scenarios and automated controls to life. The new Aqara products showcased include the Floor Lamp T1, LED Downlight T2, LED Strip T2, Outdoor String Lights H1, and Permanent Outdoor Lights H1. In addition, the company will present Aqara Builder, a platform fo
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