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
Brenus Pharma Welcomes New European and Asia-Pacific Life Sciences Investors in Series A Extension20.7.2026 22:00:00 CEST | Press release
Brenus Pharma today announced an €11 million ($12.6M) extension to its Series A round, bringing total capital raised since inception to €38 million ($43.5M). This funding reflects strong execution across clinical, regulatory, and business development milestones, de-risking STC-1010 (NCT06934538): lead clinical-stage in-vivo immunotherapy for MSS mCRC, while positioning the company’s proprietary platform for multi-asset expansion. The round was supported by strong follow-on participation from existing investors, including Angelor, UI Investissement (managing FRAI), Crédit Agricole (CACE Création, CACF Capital Innovation), Noshaq, Orsa (formerly Investsud), BIO JAG, and Bpifrance (through non-dilutive funding). This round also welcomes two new international investors: Sambrinvest, strengthening the company’s European shareholder base, and Korea Omega Investment Corp, marking its first institutional investment from the Asia-Pacific region. "We couldn't be more confident in our first inves
Hollywood Chamber of Commerce Expands Into Luxury Hospitality20.7.2026 18:30:00 CEST | Press release
Hollywood Hotels & Residences to Bring the Spirit of Hollywood to Luxury Destinations Worldwide The Hollywood Chamber of Commerce, known for the iconic Hollywood Sign® and Hollywood Walk of Fame®, is expanding into luxury hospitality through a strategic partnership with The Scene Hotels & Resorts to launch Hollywood Hotels & Residences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720026178/en/ The Scene Hotels & Resorts, with 40+ years of combined expertise in hospitality, travel, and brand development, will lead the brand’s development and management. The partnership will bring the Hollywood lifestyle to luxury hotels and branded residences around the world, creating immersive destinations inspired by the world's entertainment capital. "This partnership represents far more than an expansion of the Hollywood brand—it reflects our vision of Hollywood as the world's premier hub for entertainment, creativity, and commerce
Andersen Consulting udvider med samarbejdsfirmaet Smartbridge20.7.2026 17:54:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Smartbridge, et Texas-baseret firma, der tilbyder digitale løsninger og AI-teknologi, og forbedrer dermed sine kapaciteter inden for data og analyse samt digitale transformationstjenester. Smartbridge blev grundlagt i 2003 og hjælper organisationer med at accelerere deres digitale transformation og modernisere driften gennem digital innovation, AI, data og analyse samt applikationsmoderniseringstjenester. Firmaet arbejder med kunder inden for olie- og gas-, medtech- og restaurationsbranchen og kombinerer rådgivnings- og teknologitjenester for at muliggøre erhvervsvirksomheders transformation og vækst. Ved at udnytte strategiske relationer med førende teknologileverandører hjælper Smartbridge organisationer med at forbinde data, forbedre beslutningstagning og accelerere forretningsresultater. "I dag ønsker organisationer at accelerere deres digitale omstilling og AI-transformation og søger praktiske måder at omsætte innovation til m
Epic Flight Academy Agrees to Purchase up to 50 Pipistrel Voyager Aircraft, Supplementing Its Fleet of Trainers as It Supports Continued Pilot Training20.7.2026 17:38:00 CEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today announced Epic Flight Academy as the launch customer for the Pipistrel Voyager during Textron Aviation’s press conference at EAA AirVenture 2026. The company has signed a purchase agreement for up to 50 Voyager aircraft, with an order for 10 initial deliveries beginning in 2027, and options for up to 20 additional aircraft in 2028 and 20 in 2029, supporting the continued expansion of its training fleet and growing demand for pilot training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720003143/en/ Epic Flight Academy agrees to purchase up to 50 Pipistrel Voyager aircraft, supplementing its fleet of trainers as it supports continued pilot training (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) Epic Flight Academy is a Florida-based flight training provider offering FAA Part 141 and
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 15:00:00 CEST | Press release
Debuting at EAA AirVenture 2026 in Oshkosh, the world’s largest aviation gathering Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. c
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