Business Wire

Valbiotis announces the major success of the Phase II HEART clinical study: the patented plant-based active substance TOTUM•070 proves its efficacy against hypercholesterolemia, a cardiovascular risk factor


Regulatory News:

Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the major success of the Phase II HEART clinical study, which achieved its objective of reducing blood LDL cholesterol level (primary endpoint) with TOTUM•070 and confirmed the very good tolerance of this active substance. This multicentric, randomized, placebo-controlled, double-blind study was conducted in 120 volunteers with mild to moderate untreated hypercholesterolemia and tested a daily dose of 5 g in two intakes for 6 months. As early as three months of supplementation, TOTUM•070 significantly reduced blood levels of LDL cholesterol (-13%, p<0.01), and triglycerides (-14%, p<0.05), compared to placebo. Excess of these blood lipid markers is a cardiovascular risk factor.

Thanks to these very good clinical results, TOTUM•070, an innovative patented active substance derived from food plant extracts, without phytosterols or red yeast rice, becomes a clinically proven non-drug option for people with untreated mild to moderate LDL hypercholesterolemia, as a complement to lifestyle and dietary recommendations.

Sébastien PELTIER, Chairman of the Board of Directors at Valbiotis, comments: "This clinical success exceeds our expectations, as it shows a significant reduction in LDL cholesterol, our primary objective, as well as blood triglycerides, which are associated with cardiovascular risk. Given these positive results, the quality of the scientific data already obtained and the need for solutions for untreated patients, we have decided to market TOTUM070 after these Phase II results. In this perspective, we are already engaged in the search for commercial partnerships with a commercialization horizon no later than the first half of 2024. The TOTUM070 scientific package, combined with our market studies with patients and healthcare professionals, supports this ambition. At the same time, we will be preparing a final Phase II/III clinical step to obtain a health claim that will enhance the value of this active substance."

Results of the Phase II HEART clinical study

The HEART clinical study was a multicentric, international, randomized, placebo-controlled, double-blind study involving 120 people with untreated mild to moderate hypercholesterolemia, with blood level of LDL cholesterol between 130 mg/dl and 190 mg/dl. The participants were divided into two equivalent arms of 60 people, supplemented for six months with a daily dose of 5 g of TOTUM•070 or a placebo, in two intakes.

After a 6-month supplementation, the study achieved its objective of significantly reducing LDL cholesterol in the blood (primary endpoint, -9% versus placebo, p<0,015). As early as 3 months of supplementation with TOTUM•070, the results showed a significant lipid-lowering effect, with:

  • a significant 13% reduction in blood LDL cholesterol level, compared to placebo (p<0.015);
  • a significant 14% reduction in blood triglyceride level, compared to placebo (p<0.055).

In clinical practice, the reduction of LDL blood cholesterol as early as 3 months of supplementation is an expected benefit by patients and healthcare professionals1. The HEART study also demonstrates the persistent lipid-lowering effect at 6 months.

In addition, the study confirmed the safety and very good tolerance of TOTUM•070.

The comprehensive data from the study will be presented at international scientific conferences.

Prof. Jean-Marie BARD, professor of biochemistry and pharmacy hospital practitioner at Nantes University Hospital and at the West Institute of Cancerology (Institut de Cancérologie de l'Ouest), scientific advisor of the HEART study, comments: "The results of the HEART study are very positive. They demonstrate the efficacy of TOTUM•070 on blood LDL cholesterol, a well-known cardiovascular risk factor, and a lipid-lowering effect on triglycerides, associated with cardiovascular risk. The study also confirms the very good tolerance of this active substance: this is an important issue in lipid-lowering strategies, as emphasized by international learned societies. With these data, TOTUM•070 is therefore a very good solution to address the lack of reliable options adapted to mild to moderate hypercholesterolemia, for which only lifestyle and dietary recommendations are currently proposed." 

Murielle CAZAUBIEL, Head of Development, Medical, Regulatory and Industrial Affairs, member of Valbiotis Board of Directors, adds: "These results exceed the ambitions we had announced for TOTUM•070. It was a challenge to demonstrate the relevance of a plant-based active substance in such a demanding clinical field, in line with the preclinical data we had already published. This has been achieved. We are very proud of this achievement and would like to thank all the people involved in this study, both professionals and volunteers: thanks to them, TOTUM•070 is now a clinically proven and well-tolerated non-drug option against high cholesterol, in the context of cardiovascular risk prevention."

The efficacy and mode of action data previously obtained for TOTUM•070

The results of the HEART clinical study are consistent with the preclinical efficacy data already obtained in dyslipidemia models and presented at the American Heart Association meeting in 2021. This work showed a significant dose-dependent reduction in LDL cholesterol and triglycerides.

In addition, clinical and preclinical studies (positive clinical results published March 29, 2022) have documented the multi-target mode of action of TOTUM•070. According to these data, the lipid-lowering effect of TOTUM•070 is based:

  • at the intestinal level, on the reduction of the absorption of cholesterol;
  • at the hepatic level, on the reduction of de novo6 cholesterol synthesis.

In these studies, additional liver benefits were observed, with a decrease in cholesterol storage and a decrease in gene expression of inflammatory markers.

Targeting the marketing of the product by the first half of 2024 at the latest

Given the need for clinically proven non-drug options, as highlighted by market studies with patients and healthcare professionals, the Company sets the objective of commercialization no later than the first half of 2024, based on all of these Phase II results, and is intensifying its discussions with major players in the health and nutrition sectors.

Following the finalization of the industrial scale-up, TOTUM•070 will be offered in two galenic forms (capsules or powder for dilution), to be taken twice daily. It will be available over the counter in pharmacies (pharmacy stores or online) for patients and consumers. Available without a prescription, TOTUM•070 may be advised by healthcare professionals.

From a regulatory standpoint, TOTUM•070 can already be marketed in Europe, after notification to the DGCCRF in France (mutual recognition applicable for other European Union countries). Regulatory processes for North America and other areas are ongoing.

Mild to moderate hypercholesterolemia: patients and physicians awaiting solutions

Excess blood LDL cholesterol is the primary cause of atherosclerosis, a serious disease of the arteries with debilitating and potentially deadly cardiovascular complications (stroke, heart attack, arterial diseases, amongst others). Given the risk, hypercholesterolemia must be managed according to international guidelines, to reduce blood LDL cholesterol levels.

How is it managed?

Other than essential lifestyle changes, therapeutic strategies are defined for each patient following an assessment of their overall cardiovascular risk level: smoking, blood pressure, overweight, age, individual and family history, amongst others.

  • For the most at-risk patients, long-term drug treatments (such as statins) are recommended and effective.
  • For patients with moderate hypercholesterolemia or a lower overall risk, the initiation of these treatments is discussed between the physician and the patient depending on their benefit/risk ratio.
  • For patients with a mild form and a moderate risk, the benefit/risk ratio of the treatment is unfavorable.

A real need for solutions for patients at moderate risk

Between lifestyle-dietary rules alone and long-term treatments, there is a lack of effective, well-tolerated intermediary solutions for managing cholesterolemia, preventing it from worsening, and delaying the initiation of treatment. Confronted with this need expressed by physicians and their patients, international guidelines recognize the potential benefit of non-drug products - in particular food - but highlight the lack of clinical proof so far.

A world with high cholesterol

And yet the epidemiological data is worrying: according to the WHO, hypercholesterolemia affects 39% of adults in total worldwide with its prevalence reaching 54% in Europe and 48% in North America2.

In France, 62% of adults have a total cholesterol level above 2.0 g/l3.

Overall, it is estimated that 174 million adults in the United States and the 5 major European countries have excessive LDL cholesterol levels4.

About Valbiotis

Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular 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 and cardiovascular 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:

Name: Valbiotis
ISIN Code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-PME 150

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 filed to the French Financial Markets Regulator (AMF) on May 19, 2022. This document is available on the Company’s website (

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.

1 Market studies conducted by IFOP and A+A institutes for Valbiotis in 2022
2 Global Health Observatory, WHO (2018, data 2008)
3 Wilkins E et al., European Cardiovascular Disease Statistics 2017. European Heart Network, Brussels
4 AEC Partners, Elevated LDL cholesterol preliminary market estimation, 2020
5 Intention-to-treat analysis (ITT)
6 Cholesterol can be supplied by the diet or produced by the body itself ("de novo synthesis").

To view this piece of content from, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
Communication and Public Affairs Director
+33 6 77 82 56 88

Communication Manager
+33 5 46 28 62 58

Financial communication / Actifin
Stéphane RUIZ
Associate Director
+33 1 56 88 11 14

Media Relations / PrPa
Operational Director
+33 6 80 28 47 70

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(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

The Minister of Trade and Industry Launches the Norwegian Government's Battery Strategy at FREYR Battery in Mo i Rana27.6.2022 13:39:00 CEST | Press release

FREYR Battery (NYSE: FREY) (“FREYR”), a developer of clean, next-generation battery cell production capacity, welcomes the Minister of Trade and Industry to launch the Norwegian Government's National Battery Strategy at FREYR Battery's giga giga factory location in Mo i Rana, Northern Norway. This press release features multimedia. View the full release here: "Sentraltomta" inside Mo industrial Park (Photo: Business Wire) This was announced at the Norwegian government’s webpages Monday morning 27th June Norwegian time: FREYR Battery CEO, Tom Einar Jensen, says: “We are very proud that the Norwegian Government has chosen FREYR Battery’s giga factory location in Mo i Rana, as the historic place to launch Norway's National Battery Strategy. We warmly welcome the Minister of Trade and Industry, and experience this as a strong con

Time Manufacturing Company Acquires France Elévateur27.6.2022 12:00:00 CEST | Press release

H.I.G. Capital ("H.I.G."), a leading global alternative investment firm with over $49 billion of equity capital under management, is pleased to announce that its portfolio company, Time Manufacturing Holdings, LLC (“Time Manufacturing” or the “Company”), a leading, global provider of vehicle-mounted aerial lifts, has acquired France Elévateur (“FE Group”). The pairing of the two companies, who share a mutual dedication to quality and safety, strengthens the combined platform’s global manufacturing capabilities while enhancing value to customers through a broader portfolio of complementary products and services. Founded in 1984 and headquartered in Flavigny, France, France Elévateur is a leading manufacturer of vehicle-mounted aerial platforms for customers in various trades including public lighting, electric utility, roofing, telecommunications, rail networks, and other fields requiring access solutions. Through its two manufacturing sites in France and Spain and its footprint of 15 s

Results from Phase 2 Study of Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency Published in New England Journal of Medicine27.6.2022 12:00:00 CEST | Press release

Takeda (TSE:4502/NYSE:TAK) (“Takeda”) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that results from a Phase 2 clinical study (AROAAT-2002) of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD) were recently published in the New England Journal of Medicine (NEJM) and presented in an oral presentation at The International Liver Congress™ 2022 - The Annual Meeting of the European Association for the Study of the Liver (EASL). The NEJM article was published online ahead of print and is titled, “Fazirsiran for Liver Disease Associated with Alpha-1 Antitrypsin Deficiency.” The EASL presentation was titled, “Reduction of Intra-hepatic Z-AAT Synthesis by Fazirsiran Decreases Globule Burden and Improves Histological Measures of Liver Disease in Adults with Alpha-1 Antitrypsin Deficiency.” This press release features multimedia. View the full release here:

Seoul Viosys 'Violeds' UV-C Technology Applied to 30,000 Cubic Meters Per Day for Municipal Water Purification System from Typhon Treatment Systems27.6.2022 10:45:00 CEST | Press release

Seoul Viosys (KOSDAQ: 092190), a company specializing in optical semiconductors, announced that the ‘Violeds’ technology was supplied to Typhon Treatment Systems Ltd., a British water treatment company, and applied to the UK's Cumbria water purification plant with a daily water purification capacity of 30,000 cubic meters. This press release features multimedia. View the full release here: Typhon’s integrated array of ‘Violeds’ UV LEDs inside water pipe (Photo: Business Wire) UV lamp sterilization using mercury has been used in water purification facilities for the past several decades, and despite the restrictions on mercury products by the Minamata Convention, it was difficult to replace the sterilization performance, so it was subject to special permission. However, Violeds uses LEDs as a UV source, so it does not use mercury and reduces the amount of chemicals used for sterilization, thereby reducing the occurrence of enviro

Topdanmark deploys Guidewire for reduced IT complexity and omnichannel customer engagement27.6.2022 10:00:00 CEST | Press release

Guidewire (NYSE: GWRE) today announced that Topdanmark, Denmark’s second largest insurance company, has implemented Guidewire to lower IT architecture complexity and focus on the development of a strong platform with streamlined systems. The implementation will enable Topdanmark to engage more effectively with customers across multiple channels, to digitize policy and billing processes, and enable self-service functionality. Guidewire has been deployed to Topdanmark’s wind turbine, property, and content lines of business in their Agriculture division. This has been in parallel with deployment of a Salesforce platform that is deeply integrated with Guidewire. Further Guidewire deployments are planned in 2022 for their Private and Commercial divisions. "It has been vital for us to get the cornerstone right from the beginning by creating basic Danish insurance processes, integrations, and customer communication,” said Monica Diaz, Head of Agriculture and Commercial division. "With the cor