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.
g/L: this is the normal level of LDL-cholesterol in the blood. If levels are above this, LDL-hypercholesterolemia is diagnosed and the risk of cardiovascular diseases increases.
reduction in LDL-cholesterol levels in the blood in hypercholesterolemic patients reduces the risk of cardiac diseases by 50% over 5 years.
Source: WHO, Global Health Observatory (GHO)
TOTUM-070 is a combination of 4 food plant extracts, with no phytosterol or red yeast rice content, for which a patent has been filed in 24 countries. This Nutrition Health product was developed to reduce the levels of LDL-cholesterol in the blood and improve the lipid profile of patients with mild to moderate hypercholesterolemia.
The composition of TOTUM-070 results from research in analytical chemistry followed by preclinical studies on models predictive of human physiopathology.
It is an exclusive product for which the company aims to obtain a proprietary health claim relating to the reduction of LDL-cholesterol in the blood, a risk factor of cardiovascular diseases.
The Phase I/II clinical study completed in July 2018 demonstrated the safety and tolerance of TOTUM-070.
This pilot study also validated the methodological criteria required to design the Phase II studies: main criterion, patient profile to be included and population size.
These studies should demonstrate the efficacy of VAL-070 on the reduction of LDL-cholesterol levels in the blood.