TOTUM•070: dyslipidemia

An innovative active substance to reduce LDL-cholesterol

Designed for patients with untreated, mild to moderate LDL-hypercholesterolemia, associated with a moderate overall cardiovascular risk.
Clinical development: Phase II

Source :
1-www.inserm.fr/information-en-sante/dossiers-information/atherosclerose

Hypercholesterolemia: a major, yet modifiable, cardiovascular risk factor

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.
Today, hypercholesterolemia affects almost 30% of the French and American adult populations. 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;
-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

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.

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

Source : OMS, Global Health Observatory (GHO, données sur les hommes de 40 ans)

TOTUM•070: an innovative active substance 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 and has already been granted in Europe and the United States.
This exclusive active substance has been developed in particular for patients with mild to moderate LDL-hypercholesterolemia of up to 190 mg/dL, untreated and associated with an overall moderate cardiovascular risk.
TOTUM•070 is being developed with a view to obtaining a proprietary health claim relating to the reduction of blood LDL-cholesterol, a risk factor for cardiovascular diseases.
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Phase II clinical study in progress

Phase II of the HEART clinical study on TOTUM•070 was launched in February 2021, starting with the enrollment of volunteers.
This randomized, double-blind, placebo-controlled clinical study will include 120 patients with untreated moderate hypercholesterolemia ranging between 130 and 190 mg/dL. Participants will be divided into two equivalent arms of 60 people, receiving TOTUM•070 or a placebo for six months. The primary endpoint of the study will be the reduction of LDL-cholesterol levels; several secondary endpoints of interest will also be examined.

Intellectual property

The TOTUM•070 patent application has been filed in 23 countries, and patents have already been issued in Europe, the United States and Russia.