VALBIOTIS Authorized to Launch HEART, the Phase II Multi-center Clinical Study With TOTUM-070, for the Reduction of Blood LDL-cholesterol Levels
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.
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.
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
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-SME 150
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.
VALBIOTIS / CORPORATE COMMUNICATION
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
ACTIFIN / FINANCIAL COMMUNICATION
+33 1 56 88 11 14
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus8.3.2021 09:00:00 EET | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/ Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application. The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is supported by positive data from two pivotal phase-III trials KALM-1, condu
HD-PLC Alliance Develops Its Global Activities in High-speed Power Line Communications and High-speed Wired Communications8.3.2021 09:00:00 EET | Press release
Last year, HD-PLC Alliance *1, Fukuoka, Japan (Alliance) launched the “Global Strategy Preparatory Office”, a new ad-hoc working group, to support the advancement of IoT migration which is leading to a dramatic growth of the needs for high-speed PLC in various systems such as smart-meter, factory-automation (FA), building-automation (BA), solar power generation, smart-streetlight, smarter-city, smarter-home, etc. The Alliance announces today several initiatives as part of the development of its global activities. First, the Alliance will hold an HD-PLC *2 global web seminar (webinar) jointly with IEEE SA*3 on coming Thursday, 18th March to showcase its ecosystem footprint. Event title: [IEEE SA And HD-PLC Alliance Webinar March 2021] Home Networking, Industrial and Building Automation through HD-PLC (High Speed Powerline Communication) Official website: https://hd-plc.org/news/ , https://standards.ieee.org/events/index.html Topics covered/Agenda: HD-PLC technology and Standards, Buildi
Masimo Monitoring Solutions Promote Newborn and Maternal Safety8.3.2021 08:00:00 EET | Press release
Masimo (NASDAQ: MASI) provides a variety of innovative monitoring solutions designed to improve maternal and newborn safety during childbirth and the critical first minutes of life. Masimo SET® pulse oximetry’s ability to measure during motion and low perfusion has helped newborns, neonates, and pediatric patients like no other pulse oximetry. Not only has Masimo SET® helped clinicians reduce retinopathy of prematurity (ROP)1 and improve screening for critical congenital heart disease (CCHD),2-10 but it has helped push the standard of care for babies to new heights—the evidence from CCHD studies with SET®, for example, has been used in the establishment of screening guidelines used around the world.11 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005058/en/ Masimo Newborn Sensor (Photo: Masimo) Today, on International Women’s Day, it is especially important to recognize that, as UNICEF reports, “newborns and mothers a
High-Quality Healthcare, Education Systems Highlighted in China's Two Sessions7.3.2021 06:41:00 EET | Press release
Building Healthy China and a high-quality education system are both important content in the draft outline of the 14th Five-Year Plan (2021-2025) for national economic and social development and the long-range objectives through the year 2035, which will be reviewed by lawmakers at the ongoing National People's Congress (NPC) session. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210306005020/en/ On the second day of this year's annual session of the NPC, China's national legislature, President Xi Jinping joined a group meeting with national political advisors from the education, medical and health sectors. He attended joint group meetings with national political advisors from various sectors during the Two Sessions eight times from 2013 to 2020, hearing their comments and suggestions. Ensuring people's health Talking about work in medical and health areas, Xi reiterated holding people's health as a strategic priority, call
CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 16:02:00 EET | Press release
China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi
Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 15:30:00 EET | Press release
Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif
COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 12:00:00 EET | Press release
Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™ Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan
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