TOTUM-070

Moderate hyper-cholesterolemia: a need for safe and effective healthcare products

Hypercholesterolemia is one of the major risk factors of cardiovascular diseases. Over time, the excess of blood cholesterol, in particular LDL-cholesterol, weakens and induces artery stenosis. This “atherosclerosis” contributes to the onset of serious diseases such as myocardial infarctus, stroke and arteritis in the lower limbs.
Today, hypercholesterolemia affects almost 30% of the French and American adult population.Treatment is based on making 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 preventive treatment options available. At the current time, food products containing phytosterols are most commonly used.

 

Sources: De Peretti C et al., Étude nationale nutrition santé (ENNS) 2006-2007;
Center for disease control, 2018;
Benjamin EJ et al., American Heart Association. Circulation. 2017;
US Preventive Services Task Force, Final Recommendation Statement, JAMA, 2016.

 

Key figures

Definition

1,6

g/L: this is the normal level of LDL-cholesterol in the blood, for patients without additional cardiovascular risk factor. If levels are above this, LDL-hypercholesterolemia is diagnosed and the risk of cardiovascular diseases increases.

Reduction of risk

10%

reduction in LDL-cholesterol levels in the blood in hypercholesterolemic patients reduces the risk of heart diseases by 50% over 5 years.

Source: WHO, Global Health Observatory (GHO)

TOTUM-070: an innovative product to reduce LDL-Cholesterol

TOTUM-070 is a combination of plant extracts, with no phytosterol or red yeast rice content, for which a patent has been filed in 24 countries.

 

This exclusive product is developed for patients with mild to moderate hypercholesterolemia, to reduce their blood LDL-cholesterol, a risk factor for cardiovascular diseases.

 

TOTUM-070 is being developed in order to obtain a proprietary health claim relating to the reduction of LDL-cholesterol in the blood, a risk factor of cardiovascular diseases.

A Phase II clinical development pending

The Phase I/II clinical study completed in July 2018 demonstrated the safety and tolerance of TOTUM-070.

This study suggested a 7-10% reduction in LDL cholesterol for the next Phase II study, in people with mild to moderate hypercholesterolemia. A 10% reduction in cholesterol reduces by 50% the risk of developing a heart disease within 5 years (WHO data, in men aged 40).

 

A phase II clinical study to be launched late 2020

This randomized, placebo-controlled, double-blind study will include 120 subjects with mild to moderate hypercholesterolemia, untreated. Reduction in LDL cholesterol will be the primary endpoint. Its launch is planned late 2020, with the first results expected late 2021.

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