TOTUM•070: to reduce blood LDL cholesterol

TOTUM•070 is a unique patented combination of plant extracts, clinically proven for patients with untreated, mild to moderate LDL hypercholesterolemia, associated with a moderate overall cardiovascular risk.

• 12 communications in international scientific congresses since 2021: American Heart Association (AHA), European Society of Cardiology (ESC), European Atherosclerosis Society (EAS).
• 1 first scientific publication of the mode of action results in 2023, in the international peer-reviewed Nutrients.

Over time, excess blood cholesterol, in particular LDL cholesterol, weakens and narrows the arteries. This “atherosclerosis” contributes to the onset of serious diseases such as heart attack, stroke and arteritis of the lower limbs.
Hypercholesterolemia affects 39% of adults worldwide according to the WHO. Treatment is based on lifestyle changes, combined with prescribed drugs for patients with a high risk of cardiovascular disease. For patients classified as medium-risk, there are few non-drug, clinically proven preventive treatment options available.

Sources:
– De Peretti C et al., Étude nationale nutrition santé (ENNS) 2006-2007;
– Benjamin EJ et al., American Heart Association. Circulation. 2017;
– US Preventive Services Task Force, Final Recommendation Statement, JAMA, 2016.
¹www.inserm.fr/information-en-sante/dossiers-information/atherosclerose 

1.6 g/l: this is the normal level of blood LDL cholesterol for patients with no additional cardiovascular risk factor. Above this level, LDL hypercholesterolemia is diagnosed and the risk of cardiovascular disease increases.

Source: Fédération française de cardiologie, 2021, https://www.fedecardio.org/je-m-informe/le-cholesterol/ (accessed June 29, 2022).

A 10% reduction in the blood LDL cholesterol levels of hypercholesterolemic patients reduces the risk of heart disease by 50% over five years.

Source: WHO, Global Health Observatory (GHO, data on men aged > 40 years old).

Clinical and preclinical studies have documented the multi-target mode of action of TOTUM•070. According to these data, the lipid-lowering effect of TOTUM•070 is mainly based:

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

The results of the Phase II HEART clinical study were published on June 13, 2022.

This multicentric, international, randomized, placebo-controlled, double-blind study involved 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<0,01). 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<0.01);
• a significant 14% reduction in blood triglyceride level, compared to placebo (p<0.05).

Analyses in 84 volunteers with blood LDL cholesterol levels above 130 mg/dl at randomization, the commercially targeted population of TOTUM•070, demonstrate:

• An increased and lasting efficacy of TOTUM•070 on blood LDL cholesterol levels, with a reduction of 13.7% after three months and 14.3% after six months, compared to placebo.
• A very high response rate to TOTUM•070, reaching 92.5% of responders, from three months in this subpopulation and up to 100% responders when cholesterol levels at baseline exceeded 160 mg/dl.

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.

Previously, an open label bioavailability and mode of action study was led on 10 volunteers. Published in March, 2022, the positive results validated the bioavailability of TOTUM•070 metabolites and their effects on human liver cells in vitro.

The patent has been granted in key markets : USA, Europe, Japan, Mexico, South Africa, Brazil.

Funding

The European Union participated in the financing of the research project on TOTUM•070.
https://www.europe-en-nouvelle-aquitaine.eu/fr