Business Wire

VALBIOTIS Announces the First Patient’s First Visit in the Phase II HEART Clinical Study on TOTUM-070 and Steps up Its Research Program Against Hypercholesterolemia in 2021

Share

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.

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

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

C3 AI and Baker Hughes to Provide Enterprise AI Solutions to Accelerate PETRONAS Digital Transformation Program26.2.2021 17:00:00 EETPress 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 16:00:00 EETPress 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 14:37:00 EETPress 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 11:55:00 EETPress 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 especiall

Inspur Information Releases 2020 Global Computing Index Report26.2.2021 11:07:00 EETPress 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

Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)26.2.2021 11:00:00 EETPress release

Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us

WDR expands HD capacity with SES on ASTRA 19.2 degrees East26.2.2021 10:50:00 EETPress release

The leading German public broadcaster Westdeutscher Rundfunk (WDR), regional member of the ARD broadcasting group operating in North Rhine-Westphalia, has expanded its partnership with SES to secure an additional transponder for High Definition (HD) programming on ASTRA 19.2 degrees East orbital position in a multi-year contract. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225006378/en/ WDR expands HD capacity with SES on ASTRA 19.2 degrees East (Photo: Business Wire) Starting 3 March 2021, viewers in the region will be able to receive WDR’s entire programming in HD quality, including the popular "WDR Lokalzeit", a regionally focused program produced by WDR’s numerous local studios. Viewers who do not own an HD-capable television set will continue to receive WDR's programming in SD format until termination of SD transmitting. “Delivering reliable and high-quality free-to-air regional TV news and entertainment content i

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