Business Wire

VALBIOTIS Authorized to Launch HEART, the Phase II Multi-center Clinical Study With TOTUM-070, for the Reduction of Blood LDL-cholesterol Levels

Share

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.

Contact information

VALBIOTIS / CORPORATE COMMUNICATION
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
media@valbiotis.com

ACTIFIN / FINANCIAL COMMUNICATION
Stéphane Ruiz
+33 1 56 88 11 14
sruiz@actifin.fr

About Business Wire

Business Wire
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

CGTN: What Are Generations of Chinese Communists Striving For?27.2.2021 16:36:00 CETPress release

The Communist Party of China (CPC), the ruling party of the world's most populous nation and the second largest economy, is turning 100 this year. What has been motivating the CPC to fight against one challenge after another over the past century? This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210227005021/en/ "The original aspiration and the mission of Chinese Communists is to seek happiness for the Chinese people and rejuvenation for the Chinese nation," General Secretary Xi Jinping of the CPC Central Committee said in his report to the 19th CPC National Congress in October 2017. "This founding aspiration, this mission, is what inspires the Chinese Communists to advance," Xi said. Self-discipline, selflessness In March 2018, Xi, also the Chinese president, further explained the cause pursued by the CPC with a quote from an ancient poem: "A virtuous person is as sharp-sighted as a clear mirror hanging high, a selfless perso

Colicity Inc. Announces Closing of $345 Million Initial Public Offering26.2.2021 23:00:00 CETPress release

Colicity Inc. (the “Company”) announced the closing today of its initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, at a price of $10.00 per unit. The units are listed on the NASDAQ Stock Market (NASDAQ) and began trading under the ticker symbol “COLIU” on February 24, 2021. Each unit consists of one Class A share and one-fifth of one redeemable warrant, with each whole warrant exercisable to purchase one Class A share at a price of $11.50 per share. Only whole warrants will be exercisable. Once the securities comprising the units begin separate trading, the Class A shares and warrants are expected to be listed on the NASDAQ under the symbols “COLI” and “COLIW,” respectively. Colicity Inc. is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The Company int

C3 AI and Baker Hughes to Provide Enterprise AI Solutions to Accelerate PETRONAS Digital Transformation Program26.2.2021 15:00:00 CETPress release

C3 AI (NYSE: AI) and Baker Hughes today announced an artificial intelligence (AI) collaboration with PETRONAS, a global energy and solutions company from Malaysia, to apply BakerHughesC3.ai (BHC3) technology across PETRONAS’s strategic digital transformation programs. As the custodian of Malaysia's national oil and gas resources, PETRONAS runs an extensive digital transformation program across energy operations to extract value from data. The adoption of AI as part of its overall program for improved oil and gas productivity, asset integrity, and safety supports PETRONAS’s commitment to provide clean, efficient energy solutions by harnessing the power of technology. PETRONAS will work with energy technology, data science, and AI experts at Baker Hughes and C3 AI to collaborate on projects focused on improved reliability of energy assets in critical operations. Utilizing Microsoft Azure, PETRONAS will deploy the BHC3™ Reliability application to further improve maintenance programs for g

Avania in Position for Next Stage of Growth26.2.2021 14:00:00 CETPress release

Avania, a leading global full-service contract research organization (CRO) focused on medical technology (MedTech) development, today announced that it has successfully refinanced its existing banking facilities with Crescent Capital Group. “This new banking facility allows us to accelerate our next phase of organic and acquisitive growth over the next few years,” said Edo van Houten, CFO of Avania. “This transaction is also a reflection of the progress we have made in our brand strategy and position in the market, and it demonstrates the confidence of the financial community in our operational and strategic plan.” Avania has navigated confidently through the COVID-19 pandemic, posting a strong year of growth in 2020 despite the pandemic. The company will continue its growth trajectory as a global MedTech-focused CRO, supporting products from concept through post-market support. MedTech is all Avania does, navigating innovative medical technologies to market effectively and efficiently

Ipsen Receives Positive CHMP Opinion Recommending Cabometyx ® in Combination With Opdivo ® as First-line Treatment for Patients Living With Advanced Renal Cell Carcinoma26.2.2021 12:37:00 CETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). The European Commission, which has the authority to approve medicines for the European Union (E.U.), will now review the CHMP recommendation and a final decision on the application in the E.U. is expected in the coming months. “Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world. We’re proud to be able to share that the CHMP has confirmed a positive recommendation for Cabometyx® in combination with Opdivo®, bringing this impactful new treatment option one step closer for patients,” said Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen. “At Ipsen, w

Hiro Capital Leads $15 Million of Games VC Investment Into Snowprint Studios, Double Loop Games and Happy Volcano Games26.2.2021 09:55:00 CETPress release

Three international video game studios are the latest investments for Hiro Capital, the entrepreneur-led Venture Capital fund focused on backing innovators in Video Games, the Metaverse, Esports and Digital Fitness. The three mobile and cross-platform studios – Snowprint in Stockholm/Berlin, Double Loop Games in San Francisco and Happy Volcano in Belgium – will use Hiro’s investment to expand their development pipelines and accelerate global growth. They join UK and US Games studios Flavourworks, Polyarc and Lightfox in the Hiro Capital portfolio, alongside pioneers in the gamification of Games Streaming and Digital Fitness LIV.tv, Edgegap,FitXR and Nurvv. Ian Livingstone, co-founding partner at Hiro Capital, said, "We are excited to begin 2021 by announcing Hiro's investment in three amazing games studios, Snowprint, Double Loop and Happy Volcano. Each studio has demonstrated innovation and expertise in developing fun to play games which resonate with today’s audiences. I’m especially

Inspur Information Releases 2020 Global Computing Index Report26.2.2021 09:07:00 CETPress release

Inspur Information, a leading IT infrastructure solutions provider, has sponsored an International Data Corporation (IDC) white paper on the 2020 Global Computing Index (henceforth referred to as The Report). As the world’s first index report on computing, The Report unveils the relationship between computing power and economic development and serves as a reference for the outlook of the global digital economy. Global digital transformation has entered a phase marked by exponential growth in innovation, with the size of the digital economy projected to continue on an upward trend. As a key factor that underlies digital technology development, computing is now defining the productivity of the digital economy era. According to The Report, economic growth directly correlates with the development of computing—one point of growth in the computing index translates to a 3.3‰ rise in the size of the digital economy and a 1.8‰ growth in GDP. Specifically, AI computing market share is projected

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