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
PMCOrganometallix Announces Price Increase on All Products24.4.2026 22:55:00 CEST | Press release
Due to significant changes in market conditions, PMC Organometallix, Inc. announces that effective May 1, 2026, or as contracts permit, prices across all product lines globally will increase by 10-25%. This adjustment is driven by sustained cost pressures from key inputs including rising raw material costs and escalating freight and logistics expenses. While the company has been absorbing these increases, the current economic environment brought on by the geopolitical crisis of the Iran conflict requires this adjustment to continue providing the high-quality, consistent materials and supply reliability that customers expect. PMC Organometallix will implement these changes in a transparent, collaborative manner and values your partnership while navigating these economic challenges. Customers with questions or to discuss a specific situation should contact their account representative. About PMC Group PMC Group is a growth-oriented, diversified, global chemicals and plastics company deli
Frankfurt Higher Regional Court upholds BESREMi® arbitral award in favor of AOP Health24.4.2026 18:52:00 CEST | Press release
Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424005227/en/ Portrait Dr. Rudolf Widmann, Founder AOP Health Credit: AOP Health/Daniel Ospelt Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.” The Product in Dispute The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into
Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher24.4.2026 16:37:00 CEST | Press release
Compass is the most advanced company in classic psychedelics and has generated positive data from two ongoing large, well controlled Phase 3 clinical trials, designed to uphold the highest regulatory standardsFDA grants Compass NDA rolling submission and review request, based on Phase 3 dataCNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin, for treatment-resistant depression (TRD)CNPV further accelerates momentum and Compass is confident and ready to deliver for patients Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be en
Banma Intelligence and Alipay Launch AI Cockpit Solution Powered by Alipay AI Pay, Enabling Seamless and Secure In-Car Transactions by Voice24.4.2026 16:04:00 CEST | Press release
At the 2026 Beijing International Automotive Exhibition (“Auto China 2026”), OS and AI technology company Banma Intelligence and Alipay today launched a new AI cockpit solution integrating Alipay AI Pay, enabling drivers to complete purchases by voice command directly from their vehicle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424618328/en/ Industry-first AI Cockpit Solution with Alipay AI Pay Unveiled “In the past two years, smart cockpits have achieved rapid advances in perception and decision-making,” said Ming Cai, Banma Intelligence Chief Product Officer. “With large models onboard, vehicles can understand user intent and make recommendations. By integrating Alipay AI Pay into our AI cockpit solution, we are removing the last friction point in the in-car smart cockpit experience - drivers simply speak to pay, no phone required.” The new AI cockpit solution initially covers two high-frequency use cases: enterta
Spatial Announces the Release 2026 1.0.1: New Enhancements Across 3D InterOp, Data Prep, Meshing, and 3D Modeling SDKs24.4.2026 15:21:00 CEST | Press release
Spatial Corp., the leading software development kit provider for design, manufacturing and engineering solutions and a subsidiary of Dassault Systèmes, today announced new enhancements across several of its product lines. These updates further strengthen Spatial’s commitment to delivering high-performance solutions that optimize interoperability, data preparation, and advanced modeling workflows. Designed to improve efficiency and robustness across CAD translation, modeling, meshing, and simulation processes, the latest updates introduce expanded format support, enhanced PMI handling, and new capabilities for complex geometry processing. 3D InterOp NX Reader Enhancement for 2D Drawings The NX reader imports 2D drawings as visualization data from NX 2412 and later versions. glTF Writer Supports Draco Compression glTF export incorporates Draco compression for meshes and point-clouds to significantly reduce output file sizes. Enhanced Support for Reading Product Manufacturing Information
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