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
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 00:10:00 CEST | Press release
Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of OR
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 22:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
Clinilabs Announces Medical Leadership Appointments5.8.2026 16:05:00 CEST | Press release
Bob Dagher, M.D., Named Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., Named Principal Investigator Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership,
Interactive Brokers Adds Brazilian Futures through Brazil’s B3 Exchange5.8.2026 16:00:00 CEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that eligible clients outside of Brazil can now trade Brazilian futures in addition to equities through the B3 exchange. Interactive Brokers was the first broker to provide international investors with streamlined, low-cost access to B3. Offering Brazilian futures and equities alongside products across more than 170 markets worldwide underscores IBKR’s commitment to broadening global market access and giving clients efficient, cost-effective ways to diversify through a single, unified platform. Access to B3 provides exposure to one of Latin America’s most active and liquid markets, providing long-term growth potential across multiple sectors and another way for investors to pursue emerging market opportunities. "Global investors deserve seamless, low-cost access to the world's most compelling markets, including emerging economies shaping tomorrow's financial landscape," said Milan Galik, Chief Executive Off
Speech Processing Solutions Launches Philips SpeechLive Legal AI Assistant for Faster, More Accurate Legal Document Creation5.8.2026 15:37:00 CEST | Press release
The new SpeechLive Legal AI Assistant reduces the administrative burden on legal professionals through customizable document drafting powered by speech recognition tuned for legal terminology Speech Processing Solutions, the global leader in AI-assisted professional dictation and documentation solutions sold under the Philips brand, today announced the Philips SpeechLive Legal AI Assistant. The new solution transforms voice recordings, dictation and uploaded sources into structured, ready-to-review legal documents, helping legal professionals work faster while retaining control of the final draft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805997413/en/ The new Philips SpeechLive Legal AI Assistant is designed for turning conversations into ready-to-review legal document drafts. SpeechLive Legal significantly reduces the time needed to transform voice input into structured legal documentation, delivering consistent an
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