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
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 13:00:00 CEST | Press release
NAVIGATE comprises two pivotal Phase 3 studies investigating nizubaglustatRecruitment completed in Phase 3 registrational study in patients with late-infantile and juvenile GM1/GM2 gangliosidosesEnrollment in Niemann-Pick type C disease (NPC) Phase 3 study is ongoingTopline data from GM1/GM2 gangliosidoses Phase 3 study is anticipated in early 2028 Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, invest
Francisco Partners Closes $21 Billion Across Flagship and Agility Funds23.7.2026 13:00:00 CEST | Press release
Largest fundraise in the firm’s history brings total capital raised to more than $75 billion Francisco Partners (“FP”), a leading global investment firm that specializes in partnering with technology companies, today announced the closing of $21 billion in capital commitments across its Francisco Partners VIII, L.P. flagship fund and Francisco Partners Agility IV, L.P., its middle-market fund. FP exceeded its initial targets of $14.0 billion and $3.5 billion, respectively. This milestone builds on Francisco Partners' longstanding track record of performance, underscored by its distinction as the only firm to rank among the top three performers in each of the past six HEC-Dow Jones Large Buyout Performance Rankings.* “In our business, long-term success is created through a series of relationships built on years of trust and collaboration," said Dipanjan (“DJ”) Deb, Co-Founder and CEO of Francisco Partners. "We want to thank our investors for their support, our management teams for their
Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days23.7.2026 10:21:00 CEST | Press release
The Prague Folklore Days 2026 was held on July 17 and 18 in the heart of Prague, bringing together 56 international arts groups from Germany, Austria, Slovakia, Spain, the Netherlands, and Poland. Four Taiwanese groups took part: Hildebrand Yu’s ocarina band, the Shi-xian Huqin Orchestra, the Taipei Folk Orchestra, and the Four Strings Ensemble. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722841530/en/ Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days Led by Huang Chun-sin, the official Taiwan representative band featured a diverse lineup of ocarina, erhu, and dance performers. Their program stood out among the European groups with its distinctive character and vivid stage presence. Hildebrand Yu’s ocarina band captivated audiences with warm, uplifting melodies accompanied by the ocarina and ukulele. Yu also performed “Twilight Waltz,” delivering a heartfelt piece of poetic expression, like sunlight
Taiwan Children’s Choirs Garner Major Awards at Hungarian Choral Competition23.7.2026 09:33:00 CEST | Press release
Competing against 36 leading contenders from 20 countries, four Taiwanese children’s choirs have garnered several major awards and top honors at the 5th Budapest International Choral Celebration, showcasing Taiwan’s cultural diversity and music excellence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722613876/en/ Puzangalan Children’s Choir and Yo Wu Wei Children’s Chorus join forces with international choral ensembles and orchestras to perform Mozart’s Requiem Mass in D minor, K. 626 at the Béla Bartók National Concert Hall of Müpa Budapest. With its pure, angelic voices and exceptional vocal techniques, Puzangalan Children’s Choir from Pingtung County won the top prize, Laurea Summa Cum Laude, in the Grand Prix Competition’s Youth Choir of Equal Voices, Folklore, and Sacred Music categories. In the Open Competition, Yo Wu Wei Children’s Chorus claimed three gold prizes in the categories of Youth Choir of Equal Voices
Evotec Selects Navan to Unify Global Travel, Payments, and Expense Management23.7.2026 09:00:00 CEST | Press release
Global drug discovery leader partners with Navan to drive operational excellence and eliminate manual expense reporting Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced that Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT), the global drug discovery and development company, has selected Navan to manage its complete corporate Travel and Expense (T&E) program in its top global markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722261092/en/ Global drug discovery leader partners with Navan to drive operational excellence and eliminate manual expense reporting A life science company that is pioneering the future of drug discovery and development, Evotec had historically managed T&E independently across different countries, meaning employees were dealing with a patchwork of different tools and manual offline processes. As part of its focus on operational excellence, Evot
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