Valbiotis Announces Positive Preclinical Results for TOTUM•070 in Hypercholesterolemia, Selected and Presented at the American Heart Association (AHA) Annual Meeting
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211114005021/en/
TOTUM•070 preclinical results AHA 2021 (Graphic: Valbiotis)
Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the selection of TOTUM•070's positive preclinical results in hypercholesterolemia by the annual meeting of the American Heart Association, the leading American learned society in the cardiovascular field.
Valbiotis is presenting two posters on TOTUM•070 at the AHA meeting, which is being held November 13-15, 2021, in virtual format. The results presented show a significant reduction in total cholesterol and particularly "bad" cholesterol (including LDL cholesterol)*, as well as initial data in favor of a multi-target mode of action on lipid metabolism. They support the potential of TOTUM•070, currently in Phase II of its clinical development against hypercholesterolemia. Recruitment has been completed and results are expected in the second quarter of 2022, with LDL cholesterol reduction as the primary endpoint.
TOTUM•070 is an innovative active substance based on a combination of 5 plant extracts (without phytosterols or red yeast rice), designed to reduce LDL cholesterol, a cardiovascular risk factor and the primary cause of atherosclerosis. It is developed for people with mild to moderate, untreated hypercholesterolemia.
The two studies presented at the AHA congress confirm the efficacy of TOTUM•070 on cholesterol and blood lipids and provide initial data on the mode of action of this active substance. In the two in vivo models explored, the work demonstrates that TOTUM•070 largely prevents hypercholesterolemia, with a dose-dependent reduction in "bad" cholesterol* of up to 47%. The first data on mode of action also reveal significant effects on several key mechanisms for the regulation of lipid metabolism, notably intestinal, hepatic and inflammatory.
This in-depth work is the result of close cooperation between Valbiotis' preclinical platform in Riom (Puy de Dôme) and Bruno GUIGAS' team at the University of Leiden (Netherlands), one of the Company's longstanding academic partners.
Pascal SIRVENT, Director of Discovery, Preclinical and Translational Research, member of the Valbiotis Board of Directors, comments:"These results on TOTUM•070 are striking in their consistency. First, they confirm a strong and dose-dependent preventive effect on blood cholesterol, the ultimate target of this active substance. Furthermore, they confirm the hypothesis of a multi-target mode of action on the regulation of lipid metabolism, a central objective of our plant-based approach. This is an important data set for the development and future commercialization of TOTUM•070 in hypercholesterolemia and a very promising signal for ongoing clinical studies. Their selection by the American Heart Association Congress is of course a great source of pride and recognition of the quality of the work done by our teams and those of the University of Leiden."
Bruno GUIGAS, Assistant Professor at the University of Leiden (Netherlands), adds:
"This research project had an exciting overall ambition for TOTUM•070, for the prevention of hypercholesterolemia. For our part, we focused on the intestinal mode of action of this active substance and demonstrated a significant effect on fat absorption. This is a particularly positive result on this well-known lever of lipid metabolism regulation. As an R&D partner of Valbiotis since 2015, we are very pleased with our contribution to the success of these joint projects, whose benefits and value are clearly demonstrated through their selection by the AHA Congress."
TOTUM•070 efficacy and mode of action results presented at AHA 2021
Both studies were conducted in two in vivo models, predictive of human pathophysiology, where hypercholesterolemia was induced by a high-fat diet. TOTUM•070 was administered according to a prevention protocol together with the high-fat diet. The design included two controls: one with a high-fat diet alone and the other with a normal diet. The first study was mainly oriented to efficacy objectives and tested TOTUM•070 at three different doses for 12 weeks. The second study, oriented to mode of action hypotheses, tested 2 different doses for 6 weeks. In both protocols, the results show a significant reduction of cholesterol levels by TOTUM•070 compared to a high-fat diet alone, confirming the preventive effect sought with this active substance.
The first study demonstrates a profound efficacy of TOTUM•070 on circulating lipids, with a dose-dependent reduction of 37-48% of "bad" cholesterol (non-HDL)*, 31-42% of total cholesterol as well as 30-46% of blood triglycerides, compared to the high-fat diet alone, after 12 weeks.
In terms of mode of action, the second study provided exploratory data indicating two major effects of TOTUM•070: reduction of intestinal absorption of lipids and reduction of their accumulation in the liver.
In both models, gene expression analyses also showed that TOTUM•070 administration normalized many markers involved in lipid metabolism as well as some pro-inflammatory markers, whereas they were strongly altered by a high-fat diet alone.
Link to the posters: https://www.valbiotis.com/en/publications/
TOTUM•070 is an innovative active substance derived from food plant extracts, without phytosterols or red yeast rice, developed to act on lipid metabolism in people with hypercholesterolemia.
TOTUM•070 is currently being tested in a Phase II clinical trial, the HEART study, an international, multi-center, randomized, placebo-controlled study on 120 volunteers with mild to moderate hypercholesterolemia. Enrolment in this study was completed in September 2021 and results are expected in the second quarter of 2022.
At the end of its development, this new Health Nutrition product will be positioned in particular in people with LDL hypercholesterolemia, for levels up to 190 mg/dl, with a moderate overall cardiovascular risk. TOTUM•070 could be recommended to this large population for whom no drug therapy is currently recommended as first-line treatment, with the objective of reducing LDL cholesterol levels and thus the overall cardiovascular risk.
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, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
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) – and a subsidiary in Quebec City (Canada).
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
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150
1"Bad" cholesterol is the non-HDL fraction of cholesterol. It includes ApoB lipoproteins, i.e. VLDL and LDL cholesterol.
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 Valbiotis 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 certain risks and uncertainties, including those described in the Valbiotis Universal Registration Document approved by the French Financial Markets Regulator (AMF) on July 27, 2021 (application number R 21-039). This document is available on the Company’s website ( www.valbiotis.com).
This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Corporate communication / Valbiotis
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
Financial communication / Actifin
+33 1 56 88 11 14
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Nel ASA: Receives Purchase Order for 20MW Alkaline Electrolyser From Ovako26.11.2021 20:45:00 CET | Press release
Nel Hydrogen Electrolyser AS, a division of Nel ASA (Nel, OSE:NEL), has received a purchase order for a 20MW alkaline water electrolyser from Ovako, a leading European manufacturer of engineering steel. The electrolyser will be installed at Ovako’s existing plant in Hofors, Sweden. The fossil-free hydrogen will replace the use of fossil propane gas currently used in the heating furnaces. “We are excited to announce the delivery of electrolyser equipment to Ovako. There is huge potential in reducing CO2-emissions from steel-heating processes through green hydrogen. We look forward to working with Ovako and its partners to further develop fossil-free steel production,” says Jon André Løkke, CEO at Nel. The purchase order has a contract value of approximately EUR 11 million with equipment delivery in late 2022. The electrolyser will produce oxygen and hydrogen for Ovako’s steel-heating process and is a major step towards zero-carbon emission steel production. The conversion to hydrogen wi
'Afghan Girl' Sharbat Gula Safely Evacuated to Italy Via Efforts of Photographer Steve McCurry, Metagood/OnChainMonkey Crypto Community & Future Brilliance Charity26.11.2021 18:16:00 CET | Press release
The legendary 'Afghan Girl' photographer, Steve McCurry, and his sister, Bonnie McCurry, are delighted to announce that, together with the British-American charity, Future Brilliance, and with the support of the Italian government, and NFT for Social Good platform Metagood, they have been able to bring the famous icon for Afghan female refugees, Sharbat Gula, to safety. Background: Six weeks ago, Bonnie McCurry reached out to Future Brilliance founder, impact pioneer, and investor Sophia Swire who has a 30-year track record of empowering women in Afghanistan. She told Sophia that Sharbat Gula wanted to be evacuated with her family. After considering all the various country options, they confirmed with Sharbat that her family hoped to seek asylum in Italy. Sophia and her team activated the Future Brilliance network in Afghanistan and, together with the McCurry family, arranged the necessary paperwork, visas, and logistics. The NFT for good platform Metagood (who worked with McCurry to d
ZOVOO Held Distributor Conference, Creating a Splash of Colour in Atomization Industry26.11.2021 16:45:00 CET | Press release
At 9:30pm (GMT +8) on November 12, ZOVOO, a new industry-leading atomization company, held its 2021 distributor conference online. Distributors from United States, United Kingdom, France and other countries participated in the conference. Meanwhile, ZOVOO also displayed its newly developed disposable products DRAGBAR series for the first time to the public, which attracted widespread attention from distributors worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005521/en/ (Photo: Business Wire) Founded in 2010, ZOVOO has sophisticated research and develop capability, forward-looking product design and perfect supply chain system. ZOVOO founding team has 10 years of proven strength and experience. They have the absolute advantages in terms of heating materials, air channel structure design, etc., and build up the five criteria of good flavor. The birth of each product needs to go through from R&D, design, product
Indeed and Quandoo Announce Partnership to Support the Restaurant Industry Hiring Crisis26.11.2021 15:21:00 CET | Press release
Indeed, the world’s largest jobs site, and Quandoo, one of the fastest growing restaurant reservation platforms worldwide, today announce a partnership to support the restaurant industry's current hiring crisis. This partnership will see restaurants be provided with £50 credit to post a sponsored job advertisement on Indeed’s platform. Sponsored jobs advertisements receive optimal visibility and are more likely to deliver hires* which Indeed and Quandoo hope will connect staff with the restaurants that need them the most. Employers posting a job on Indeed for the first time will have £50 credited to their account to start sponsoring their jobs and reaching more candidates. Employers in the UK can claim the offer here. “We are so excited about this partnership. It’s a topic that is close to home for us at Quandoo as we are hearing how challenging it is to find staff from our partners. So we wanted to do our bit to support the wider industry in any way we can. By partnering with Indeed w
The Leading Event for Payment, Identification and Security Professionals, TRUSTECH will present all the Latest trends in the sector26.11.2021 10:34:00 CET | Press release
For three days, professionals of the cards and digital trust technologies industries will meet at the TRUSTECH exhibition in Paris to discuss the issues and challenges of identity, security and payment, which are the real pillars of the digital transition for institutional or commercial organisations. A panel of international speakers will share their insights across the multiple conference sessions The 6,000 attendees expected from all over the world will also be able to discover concrete solutions to optimise their business and develop their practices. Visitors will have FREE access to participateat Trustech conferences program. AUTHENTICATION AND IDENTIFICATION: A STRATEGIC ISSUE FOR GOVERNMENTS AND ORGANISATIONS These new demands on governments require the use of increasingly complex technologies and processes.Digitization brings into question how the use of physical official documents will be used in the future. It also implies there will be new innovations regarding how physical
Vifor Pharma supports Iron Deficiency Day 2021: Call to action for early iron deficiency diagnosis26.11.2021 07:00:00 CET | Press release
Already for the seventh consecutive year of Iron Deficiency Day, Vifor Pharma is supporting a growing international alliance including the Heart Failure Policy Network, European Kidney Health Alliance, Global Heart Hub and Croí the West of Ireland Cardiac Foundation with the aim to educate people about the importance of iron for the body and what can happen if iron levels are not properly managed. Iron Deficiency Day 2021 encourages people at risk to listen to their body, to take iron seriously and to take control over their health by seeking early diagnosis and medical help from their physician. Iron Deficiency affects about half of the patients with chronic kidney disease2 and chronic heart failure and is associated with reduced quality of life3, an increased risk of hospitalization4 and cardiovascular death5. Despite the serious consequences and high prevalence, of iron deficiency, the condition remains under-recognized6. Diagnosis and treatment of iron deficiency has been further i
LightCON Unveils Global Teaser Site for New Mobile Game 'Rise of Stars (ROS)'26.11.2021 03:00:00 CET | Press release
Rise of Stars (ROS), a new mobile game that is being developed by LightCON, a subsidiary of WEMADE MAX (Co-CEOs: Hyunguk Chang, Gilhyung Lee) (KOSDAQ: 101730), today opened its global teaser site. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211125006252/en/ LightCON unveils global teaser site for new mobile game 'Rise of Stars (ROS).' ROS is a new mobile SF strategy game featuring elaborately designed warships and planets set in the vast universe. Under the slogan, 'The 4x Blockchain Game for the Greatest Conqueror,' the teaser site was designed to help users experience the unique atmosphere of ROS and the game concept with the representative image of the game. ROS will be building a system for players to obtain game tokens through resource mining within planets. It aims for a global launch in the 1st quarter of 2022. (Graphic: Business Wire) Under the slogan, ‘The 4x Blockchain Game for the Greatest Conqueror,’ the tease